I I CS Health Care Guideline: Management of Labor · 2012-09-08 · Health Care Guideline:...

Health Care Guideline:

Management of Labor

Third Edition May 2009

I ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT

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Health Care Guideline:

Management of Labor

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Copyright © 2009 by Institute for Clinical Systems Improvement 1

A = Annotation

Third Edition May 2009

Is fetal heart rate a concern?

16

Pregnant patient > 20 weeks with symptoms

of labor

1

Triage for symptomsof labor

2

A

< 37 weeks?

3

See Management of Signs/Symptoms of

Preterm Laboralgorithm and

annotations

4

yes

Is patient in labor?

5

A

no

• Patient education for reassurance• Observe and re-evaluate• Consider labor induction if appropriate

6

noPrevious uterine

incision?

9

yes

Subsequent labor?

7

yes

Intrapartum care• Cervical exam• Supportive care• Adequate pain relief• Perform amniotomy if needed unless contraindicated• Monitoring of fetal heart rate• Nurse ausculatory monitoring or continuous EFM-ext

no

See VBAC algorithmand annotations

10

yes

11

A

Any concerns or complications?

12

A

Management of third stage of labor

no

See Intrapartum FetalHeart Rate Management

algorithm and annotations

See Management of Labor Dystocia algorithm and

annotations

18

Other• Out of guideline

yes

no

Out of guideline

8

Normal vaginal delivery

13 14

A

no

17

Is progression of labor a concern?

no

15

19

yes yes

Institute for Clinical Systems Improvement

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Management of Signs/Symptoms of Preterm Labor (PTL) Algorithm

Management of Labor Third Edition/May 2009

This algorithm applies to singleton pregnancies only.

Patient and fetus both medically

stable?

Is there a critical event?

21

23

no

yes

Cervix > 2 cm dilated, > 80%

effaced, contractions 4/20 or 6/60?

25

Ultrasound cervical length < 2.5 cm or fFn

positive?

26

no

yes

no

yes

no

Obstetric/medicalconsultation as indicated;

treat per standard emergency medical and obstetric

procedures

22

See Management of Critical Event algorithm

24

Assessment of patient with signs/symptoms of possible PTL

20

A

Assessment includes:

• Sterile speculum exam - Fetal fibronectin testing - Consider GBS, wet prep for bacterial vaginosis - GC, chlamydia• Digital cervical exam• Transvaginal ultrasound for cervical length (if available)• Ultrasound for growth, fluid, placenta• Assess contraction patterns• Assess fetal well-being• Urinalysis and urine culture

20

See ICSI Routine Prenatal Care

guideline

28

Critical events:

• Cervix 5+ cm dilated• pPROM• Vaginal bleeding• Chorioamnionitis suspected

23

Cervical change?

29

See Management of Critical Event algorithm

30

yes

• Consider antenatal cortiosteroids• Dismiss and schedule weekly follow-up - Digital exam to assess cervix - Repeat fFn until 33 weeks plus 6 days

31

Monitor for minimum2 hours for cervical

changes

27

no

yes


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A = Annotation

Management of Critical Event Algorithm

Possibly initiate tocolytics, antenatal corticosteroids and antibiotic group B streptococcus (GBS) prophylaxis

Deliver for:• Fetal distress• Chorioamnionitis• Active labor• 34 weeks PROM• Other obstetrical indicators

Cervix 5+ cm dilated?

Patient has critical event

33

Initial dose antenatal corticosteroids STAT, IV

antibiotics for groupB streptococcus (GBS) and

plan for delivery

yes

34

A

Safe to transfer or transport mother

before birth?

35

Prepare for preterm delivery/neonatal

transport

36

no

Chorioamnionitis suspected?

38

no

Broad spectrum antibiotics

yes

39

Plan for delivery

40

yes

• Stabilize on tocolytics• Transfer mother to appropriate level of care if possible

41

Antenatal corticosteroids23-34 weeks

42

A

Sonogram for:• Amniotic fluid index (AFI)• Presentation/placentation• Follow-up level II as indicated

43

Sonogram detects gross

anomaly?

44

Fetal anomaly compatible with

life?

45

no

47

ROM?

48

Vaginal pool + amnio at 32+ weeks for fetal lung

maturity (FLM)

yes

49

Vaginal bleeding?

50

no

Management of preterm labor with bleeding

yes

51

A

no

Fetal lung maturity (FLM) study

positive?

53

Preterm delivery

55

yes

A

A

32

A

yes no Await spontaneous labor

46

yes

Deliver for:• Disseminated intravascular coagulation (DIC)• FLM• Fetal distress• Nonreassuring FHT• Significant bleeding

52

A

54

no

A

• Stabilize on tocolytics• Transfer mother to appropriate level of care if possible

37

A

no


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Vaginal Birth After Caesarean (VBAC) Algorithm

A = AnnotationPatient in active labor with previous uterine

incision

56

Special considerations of labor management

57

A

Vaginal birth appropriate?

58

Repeat Caesarean delivery

no

Normal labor?62

59

yes

Complicated labor management

no

60

A

Vaginal birth

yes

61

• Availability of Caesarean delivery team• Review prior op report regarding previous uterine incision• EFM and intermittent auscultation• Use of foley bulb catheter for cervical ripening• Epidural anesthesia

57

Signs and symptoms of uterine rupture:• Fetal distress• Uterine pain• Hemorrhage• Palpation of fetal parts• Loss of contraction• Recession of presenting part• Fetal death

60


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Management of Labor Dystocia Algorithm

Labor dystocia diagnosis

Stage I labor Stage II labor

64 70

Fetal head descent

> 1 cm/hour?

71

A

Normal vaginal delivery

72

yes

< 1 cm dilation for 2 consecutive

hours?

65

Management of protracted labor• Evaluate potential causesConsider: - IV fluids - Amniotomy - Decrease anesthesia - Oxytocin augmentation - IUPC - OB/surgery consult

66

Adequate labor for 2-4 hours with

cervical change?

67

yes

Caesarean delivery

69

yes

Management of protracted labor• Evaluation of maternal and fetal position• Oxytocin augmentation• Allow contractions to move fetus• Decrease anesthesia• Evaluate fluid balance• Consider assisted delivery• Consider OB/surgery consult

73

A

no

Is the head descending?

74

yes

Assistedvaginal delivery

indicated?

75

A

no

no

Assisted vaginal delivery

yes76

no

no

A

Arrest of labor

68

63

A A

A


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Intrapartum Fetal Heart Rate (FHR) Management Algorithm

A = Annotation

Assessment and remedial techniques

Further FHR assessment predictive of normal acid-base

status?

FHR pattern is predictive of normal

acid-base status?

80

82

no

FHR pattern predictive of

normal acid-base status now?

83

Vaginal delivery imminent?

no

84

no

86

A

A

Expedited vaginal delivery

yes

85

Consider amnioinfusion for oligohydramnios and severe

variable or prolonged decelerations

79

Continuous EFM-ext orEFM-int (if needed)

78

Concern about fetal heart rate

77

See algorithm #12, "Any concerns or complications?"

yes

Emergent delivery

87

A

81

yes

yes

A

no

A


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Algorithms and Annotations ....................................................................................... 1-29Algorithm (Main) ............................................................................................................... 1Algorithm (Management of Signs/Symptoms of Preterm Labor [PTL]) ........................... 2Algorithm (Management of Critical Event) ....................................................................... 3Algorithm (Vaginal Birth After Caesarean [VBAC]) ......................................................... 4Algorithm (Management of Labor Dystocia) ..................................................................... 5Algorithm (Intrapartum Fetal Heart Rate [FHR] Management) ........................................ 6Foreword

Scope and Target Population ......................................................................................... 8Clinical Highlights and Recommendations .................................................................. 8Priority Aims ................................................................................................................. 9Related ICSI Scientific Documents .............................................................................. 9Disclosure of Potential Conflict of Interest ................................................................... 9Introduction to ICSI Document Development .............................................................. 9Description of Evidence Grading................................................................................ 10Abbreviations .............................................................................................................. 10

Annotations ..................................................................................................................11-27Annotations (Main) .................................................................................................11-14Annotations (Management of Signs/Symptoms of Preterm Labor [PTL]) ............ 15-16Annotations (Management of Critical Event) ........................................................ 16-20Annotations (Vaginal Birth After Caesarean [VBAC]) ......................................... 20-22Annotations (Management of Labor Dystocia) ..................................................... 22-24Annotations (Intrapartum Fetal Heart Rate [FHR] Management) ......................... 24-27

Appendix A – Patient Education Handout ................................................................... 28-29Supporting Evidence.................................................................................................... 30-51

Brief Description of Evidence Grading ............................................................................ 31References ...................................................................................................................32-39Conclusion Grading Worksheets .................................................................................40-51

Conclusion Grading Worksheet A – Annotation #20 (Bacterial Vaginosis) ..........40-43Conclusion Grading Worksheet B – Annotation #66 (Management of Protracted Labor) ..................................................................44-51

Support for Implementation ..................................................................................... 52-60Priority Aims and Suggested Measures ............................................................................ 53

Measurement Specifications .................................................................................. 54-58Knowledge Resources ...................................................................................................... 59Resources Available.......................................................................................................... 60

Table of Contents

Work Group LeaderDouglas Creedon, MDOB/Gyn, Mayo ClinicWork Group MembersFamily MedicineLeslie Atwood, MDAllina Medical ClinicLori Bates, MD Mayo ClinicDana-Rae Barr, MDHennepin County Medical CenterNurse MidwifeAnna Levin, CNMPark Nicollet Health ServicesCherida McCall, CNMHealthPartners Medical GroupRuth Wingeier, CNMCentraCareNursingBecky Walkes, RNMayo ClinicOB/GynDale Akkerman, MD Park Nicollet Health ServicesPerinatal MedicineLeslie Pratt, MDPark Nicollet Health ServicesFacilitatorsLinda Setterlund, MA, CPHQICSILynette Wheelock, RN, MSICSI


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Foreword

Scope and Target PopulationAll women who present in labor.

Clinical Highlights and Recommendations• Confirm active labor before admitting to facility evidenced by:

- Spontaneous contractions at least 2 per 15 minutes, and two or more of the following:

• Complete effacement of cervix

• Cervical dilation greater than or equal to 3 cm

• Spontaneous rupturing of membranes (SROM)

(Annotation #5)

• Perform amniotomy early in labor if indicated as discussed in the guideline. (Annotation #11)

• Assure fetal well-being with either intermittent auscultation or continuous electronic fetal heart rate monitoring. (Annotation #11)

• Patient's level of risk should be assessed on presentation of active labor.

- Oligohydramnios

- Chronic and acute medical conditions of mother and/or fetus

(Annotation #12; Aim #4)

• Start appropriate treatment for the type of preterm labor involved as soon as possible after preterm labor is identified. Treatment should be based on specific symptoms, as well as gestational age and condition of the mother and fetus. (Annotation #20; Aim #1)

• Women with preterm labor at appropriate gestational age should receive a single course of antepartum steroids to promote fetal lung maturity. (Annotations #34, 42, 47; Aim #1)

• Conduct frequent cervical checks (cervical checks afford best opportunity to detect labor progress and prevent failure to progress). (Annotation #65)

• Augment with oxytocin to achieve adequate labor for two to four hours. (Annotation #66)

• If patient is in Stage II labor and is not making progress, initiate management of protraction disorders (positioning, fluid balance, oxytocin augmentation, OB/surgical consult). (Annotation #73; Aim #2)

• When necessary, initiate remedial techniques such as maternal position, cervical exam for cord prolapse, monitoring maternal blood pressure, assessment for uterine hyperstimulation, discontinuing oxytocics and amnioinfusion. (Annotation #82; Aim #5)

• Recognize and manage fetal heart rate abnormal patterns. (Annotation #80; Aim #6)



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Priority Aims 1. Increase the percentage of women with PTL and/or PTB who receive antenatal corticosteroids appro-

priately.

2. Prevent unnecessary protracted labor with use of Management of Labor Dystocia algorithm and annota-tions and its methods.

3. Increase the use of procedures that assist in progress to vaginal birth.

4. Increase the percentage of women who are assessed for risk status on entry to labor and delivery.

5. Increase the use of remedial techniques that resolve temporary abnormal fetal heart tracing in labor.

6. Perform an appropriate evaluation for persistent abnormal fetal heart rate tracing in labor before Caesarean.

Related ICSI Scientific DocumentsGuidelines

• Routine Prenatal Care

Disclosure of Potential Conflict of InterestICSI has adopted a policy of transparency, disclosing potential conflict and competing interests of all indi-viduals who participate in the development, revision and approval of ICSI documents (guidelines, order sets and protocols). This applies to all work groups (guidelines, order sets and protocols) and committees (Committee on Evidence-Based Practice, Cardiovascular Steering Committee, Women's Health Steering Committee, Preventive & Health Maintenance Steering Committee and Respiratory Steering Committee).

Participants must disclose any potential conflict and competing interests they or their dependents (spouse, dependent children, or others claimed as dependents) may have with any organization with commercial, proprietary, or political interests relevant to the topics covered by ICSI documents. Such disclosures will be shared with all individuals who prepare, review and approve ICSI documents.

No work group members have potential conflicts of interest to disclose.

Introduction to ICSI Document DevelopmentThis document was developed and/or revised by a multidisciplinary work group utilizing a defined process for literature search and review, document development and revision, as well as obtaining input from and responding to ICSI members.

For a description of ICSI's development and revision process, please see the Development and Revision Process for Guidelines, Order Sets and Protocols at http://www.icsi.org.

Management of Labor Foreword Third Edition/May 2009


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Evidence Grading SystemA. Primary Reports of New Data Collection:

Class A: Randomized, controlled trial

Class B: Cohort study

Class C: Non-randomized trial with concurrent or historical controls Case-control study Study of sensitivity and specificity of a diagnostic test Population-based descriptive study

Class D: Cross-sectional study Case series Case report

B. ReportsthatSynthesizeorReflectUponCollectionsofPrimaryReports:

Class M: Meta-analysis Systematic review Decision analysis Cost-effectiveness analysis

Class R: Consensus statement Consensus report Narrative review

Class X: Medical opinion

Citations are listed in the guideline utilizing the format of (Author, YYYY [report class]). A full explanation of ICSI's Evidence Grading System can be found at http://www.icsi.org.

Abbreviations Used in This GuidelinefFN fetal fibronectin

FHR fetal heart rate

FHT fetal heart tracing

FLM fetal lung maturity

GBS group B streptococcus

N, P, F nitrazine, pooling and ferning

PROM premature rupture of membranes

pPROM preterm premature rupture of membranes

PTL preterm labor

ROM rupture of membranes

VBAC vaginal birth after Caesarean

Management of Labor Foreword Third Edition/May 2009


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Algorithm Annotations

The recommendations in this guideline are supported by large controlled studies. The guideline work group would prefer to refer to double-blind studies, but it is not feasible to blind a woman to whether she is having labor or delivery. It is unsafe to blind care providers to whether a woman has had a previous Caesarean delivery or not or previous labor and delivery complications. It is also unsafe to blind providers to whether persistent non-reassuring heart rate tracings have occurred. Given these limitations, the work group feels confident of the literature support for the recommendations within this guideline. Furthermore, these recommendations are consistent with the latest practice patterns published by the American College of Obstetricians and Gynecologists.

Management of Labor Main Algorithm Annotations

2. Triage for Symptoms of Labor Hospital and/or clinic triage for the labor patient will include these questions. Triage staff will assess general questions from OB experience. Some questions may require more details for assessment. Generally, the patient is encouraged to remain home as long as possible. The caregiver will manage any/all medical concerns according to accepted standards.

General Questions:

• Are you having contractions?

• Is this your first baby?

• Was your cervix dilated at least 2-3 cm on your last office visit?

• Did you have medical complications during your pregnancy? Get specifics.

• Are you at term? (What is your estimated date of conception?)

SpecificQuestions:

• Is your baby moving as usual?

- If no, advise go to hospital.

• Has your water broken?

- If yes, advise go to hospital.

• Are you bleeding?


• Are you having unbearable contractions?


When a patient presents to hospital and assessment shows the patient is NOT in labor: Patient education will include signs to look for, changes to assess, and reassurance that she can come back to the hospital when changes occur. When the caregiver prefers to hold and observe the patient, a reassessment must be conducted prior to release from the hospital.



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5. Is Patient in Labor? Laborisdefinedas:

Spontaneous contractions at least 2 per 15 minutes and at least two of the following:

• Complete effacement of cervix

• Cervical dilation 3 cm or greater (cervical exam #1)

• Spontaneous rupturing of membrane (SROM)

Onlypatientswhomeetthisdefinitionoflaborshouldbeadmittedforcarefulmanagementoflabor.Careful assessment of presenting patients is critical.

Patients who are not in labor should receive education that includes signs to look for, changes to assess, and reassurance that they can come back to the hospital when changes occur. (See Appendix A, "Patient Educa-tion Handout.") A patient may be placed on "hold" status for observation. Hold patients require medical reassessment before leaving the hospital.

If the patient's cervix is dilated less than 3 cm and oxytocin is started, this should be considered induction of labor, NOT augmentation of labor (American College of Obstetricians and Gynecologists, The, Practice Bulletin, 2003 [R]).

11. Intrapartum Care See ICSI Admission for Routine Labor Order Set.

Characteristics of care for a patient at time of admission to labor and delivery include:

• Chart evaluation

• Cervical exam #2

• Appropriate supportive care/comfort measures as per individual provider. May include, but are not limited to PO fluids, fluid balance maintenance, position changes, back rubs, music, ambulation, and tub bath/shower. Management of labor using patient care measures and comfort measures is supported. Documentation of progress of labor using a graphic medium is helpful to patient and staff (McNiven, 1992 [D]; Radin, 1993 [C]).

• Adequate pain relief. This includes parenteral analgesics, e.g., nalbuphine hydrochloride (such as Nubain), butorphanol tartrate (such as Stadol) or hydroxyzine hydrochloride (such as Vistaril) or epidural or intrathecal narcotics for patients in active progressing labor (continued dilation of the cervix) (Clark, 1998 [A]; Halpern, 1998 [M]; Rogers, 1999 [C]).

• Documentation of progress of labor using a graphic medium (partogram) is started on admission.

• Monitoring of fetal heart rate. (See Intrapartum Fetal Heart Rate [FHR] Management algorithm and annotations).

• Amniotomy unless contraindicated. Amniotomy should be done early in labor unless spontaneous rupture has occurred or contraindications are present. Early amniotomy has been shown to be asso-ciated with a decrease in duration of labor and is part of the failure to progress protocol (Brisson-Carroll, 1996 [M]; Fraser, 1993 [A]; Fraser, 2000a [M]; Garite, 1993 [A]).

Management of Labor Algorithm Annotations Third Edition/May 2009


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Contraindications for amniotomy include:

• Presentation unknown, floating or unstable

• Cervix dilated less than 3 cm

• Patient refuses

Continuous Electronic Fetal Heart Rate Monitoring or Intermittent AuscultationThe established purpose of fetal heart rate (FHR) monitoring is to identify fetal hypoxemia and acidemia so timely intervention can prevent fetal morbidity and mortality. This is based on the rationale that FHR patterns are indirect markers for hypoxemia and acidemia since the central nervous system controls heart rate. Virtually all obstetrical organizations advise monitoring the FHR during labor, although no trials have compared FHR monitoring versus no monitoring (Freeman, 2002 [R]). The most common methods of FHR monitoring are continuous electronic FHR monitoring (EFM) and intermittent auscultation. EFM can be done with an external cardiotocography monitor or an internal (scalp) lead and can provide a continuous assessment of FHR variability and any changes from the baseline heart rate (see table of interpreting FHR monitoring). Intermittent auscultation consists of auscultating FHR with either a DeLee stethoscope or a Doppler probe for 30 seconds immediately following a contraction. This monitoring must be performed every 30 minutes during Stage I of labor and every 15 minutes during Stage II (American College of Obestetrics and Gynetcolgists, The, 2005 [R]).

Analysis of data from randomized trials comparing these two techniques shows:

• No difference in the rate of intrapartum fetal death rate (approximately 0.5 per 1,000 births with either approach)

• No difference in APGAR scores and NICU admissions

• Neither approach has resulted in a reduction in cerebral palsy or incidence of infant neurologic impairment

Several advantages to EFM have been demonstrated, including a reduction in neonatal seizures (Alfirevic, 2006 [M]) and better prediction of fetal acidemia at birth (Vintzileos, 1993 [A]; Vintzileos, 1995 [M]). One disadvantage to EFM is that it leads to higher assisted deliveries and Caesarean birth without an associated neonatal benefit (Alfirevic, 2006 [M]). Compared to intermittent auscultation, EFM is associated with a twofold increase in Caesarean delivery rate for non-reassuring FHR patterns.

12. Any Concerns or Complications?Risk assessment should be performed on all patients in active labor and is the responsibility of all members of the health care team. This includes, but is not limited to nurses, midwives and physicians. Patient is in active labor. (See Annotation #5, "Is Patient in Labor?" for specific definition.)

Initial assessments on entry into labor and delivery area:

• Fetal heart rate assessment (Cheyne, 2003 [A]; Impey, 2003 [A])

• Patient assessment

• Prenatal risk review

• Risk in labor assessment



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High-risk situations may include any of the following conditions:

• Abnormal fetal heart rate (see Intrapartum Fetal Heart Rate [FHR] Monitoring algorithm and anno-tations)

• Situations that involve arrest or protraction disorders (see Management of Labor Dystocia algorithm and annotations)

• Bleeding

• Breech presentation

• Dysfunctional labor

• Fetal congenital heart disease

• Intrauterine growth retardation

• Maternal congenital heart disease

• Maternal diabetes or gestational diabetes

• Maternal hypertension

• Maternal lupus

• Multiple gestation

• Oligohydramnios

• Other serious chronic and acute medical conditions of mother and/or fetus

• Oxytocin use

• Postdate pregnancy (greater than or equal to 42 weeks, per physician discretion)

• Thick meconium

For the evaluation of fetal heart rate in high-risk labor see (Haverkamp, 1976 [A]; Renou, 1976 [A]; Vintzi-leos, 1993 [A]; Vintzileos, 1995 [M]).

14. Management of Third Stage of LaborActive Management of the third stage of labor should be offered to women since it reduces the incidence of postpartum hemorrhage due to uterine atony. Active management of the third stage of labor consists of interventions designed to facilitate the delivery of the placenta by increasing uterine contractions and to prevent postpartum hemorrhage by averting uterine atony. The usual components include:

• administration of uterotonic agents,

• controlled cord traction, and

• uterine massage after delivery of the placenta, as appropriate.

(Elbourne, 2003 [M]; International Confederation of Midwives [ICM], 2004 [R])



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Management of Signs/Symptoms of Preterm Labor (PTL) Algorithm Annotations

20. Assessment of Patient with Signs/Symptoms of Possible Preterm LaborBe certain intervention is appropriate, including certainty of gestational age. A sonogram should be consid-ered if one has not been done.

A thorough medical evaluation should include the following:

• Perform a sterile speculum exam to visualize the cervix to:

- identify any source of bleeding or cervical or vaginal pathology or trauma

- estimate dilation and effacement of the cervix and look for pooling of amniotic fluid as a sign of ruptured membranes

- obtain samples for fetal fibronectin testing (fFN)*, consider samples for gonorrhea, chlamydia, (Andrews, 2000 [C]) wet prep for bacterial vaginosis**, group B streptococcus (GBS), and a sample for detecting amniotic fluid with either ferning, nitrazine paper, or Amnisure

* Perform fetal fibronectin testing (fFN), if patient is between 24 and 34 weeks gestation, and cervix less than 3 cm dilated. Patients with a negative test can expect pregnancy to continue for 7-14 days.

** Consider screening high-risk women with a history of at least one preterm delivery for bacte-rial vaginosis. If positive, treatment should include oral metronidazole. Treatment of bacterial vaginosis infection in pregnant women at high risk for preterm delivery by traditional seven-day courses of therapy early in pregnancy appears to reduce preterm delivery. [Conclusion Grade II: See Conclusion Grading Worksheet A – Annotation #20 (Bacterial Vaginosis)] The evidence regarding treatment of low-risk, pregnant women with asymptomatic bacterial vaginosis is limited by use of inadequate therapy in the available studies. [Conclusion Grade Not Assignable: See Conclusion Grading Worksheet A – Annotation #20 (Bacterial Vaginosis)]

(Carey, 2000 [A]; Leitich, 2003 [M]; McDonald, 1997 [A]; McGregor, 1995 [C]; Morales, 1994 [A]; Tebes, 2003 [R])

• Perform digital cervical exam if membranes are intact and there is no vaginal bleeding. If ruptured, digital exams increase the risk of infection.

• Obtain transvaginal sonogram (TVS) for cervical length for monitoring of patients with sign/symp-toms of preterm labor and early cervical change. Cervical length of less than or equal to 25 mm or a rapidly thinning cervix correlate with increased preterm birth rates (Vendittelli, 2000 [R]).

• Perform bedside ultrasound (if feasible) to assess:

- Presentation

- Amniotic fluid index

- Biophysical profile

- Estimated fetal weight

• Assess contraction pattern



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• Assess fetal heart rate pattern and fetal well-being

• Obtain urinalysis, urine culture and urine drug screen (if appropriate)

Consider non-intervention near-term if gestational age is well documented. Do not inhibit labor where there is fetal or maternal jeopardy, fetal malformation or death.

Evidence indicates prophylaxis with progesterone may decrease the reoccurrence of preterm labor in women with a history of one or more preterm births (da Fonseca, 2003 [A]; Meis, 2003 [A]). See ICSI Routine Prenatal guideline.

Fish oil supplementation has not been found to be helpful in preventing preterm labor. One analysis of six clinical trials found an increase in intracranial hemorrhage among infants whose mothers took fish oil supplements during pregnancy compared to those who took olive oil (Olsen, 2000 [A]).

DefinitionofPretermLabor:

• Labor occurring after 20 and before 37 completed weeks plus

• Clinically documented uterine contractions (4/20 minutes or 6/60 minutes) plus

• Ruptured membranes or

• Intact membranes and cervical dilation greater than 2 cm or

• Intact membranes and cervical effacement greater than 80% or

• Intact membranes and cervical change during observation. These can be measured by changes in dilation or effacement, or by changes in cervical length measured clinically or by ultrasound.

Management of Critical Event Algorithm Annotations

34. Initial Dose Antenatal Corticosteroids STAT, IV Antibiotics for Group B Streptococcus (GBS), and Plan for DeliveryPlease refer to Annotation #47, "Possibly Initiate Tocolytics, Antenatal Corticosteroids and Antibiotic Group B Strepcoccus (GBS) Prophylaxis," for information on dosing of other corticosteroids.

37. Stabilize on Tocolytics/Transfer Mother to Appropriate Level of Care if PossibleSeveral medications are available for the inhibition of preterm labor (tocolysis). These drugs have different routes of administration, dose schedules, safety profiles, contraindications, and fetal and maternal side effects (Simhan, 2007 [R]). Although several medications can prevent delivery for 24-48 hours (allowing time for the administration and beneficial effects of corticosteroid therapy), the longer-term efficacy of all tocolytics is poor (Gyetvai, 1999 [M]).

Magnesium sulfate

Review of the literature does not support the efficacy of magnesium sulfate as a tocolytic. The largest random-ized, placebo-controlled trial showed no benefit over placebo (Cox, 1990 [A]). A more recent meta-analysis of 11 studies showed no benefit regarding the risk of preterm birth (less than 37 weeks) or very preterm birth (less than 34 weeks). Moreover, in seven of the trials analyzed, the risk of perinatal mortality was increased for infants exposed to magnesium sulfate (Crowther, 2002 [M]; Grimes, 2006 [R]; Mittendorf, 2002 [R]). The work group does not recommend the use of this medication for this indication.



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A series of recent randomized controlled trials (Doyle, 2009 [M]; Marret, 2008 [A]; Rouse, 2008 [A]) evaluated the administration of magnesium sulfate in clinical situations when preterm delivery is regarded as imminent. Review of these trials has suggested magnesium sulfate does not work well as a tocolytic, but does provide a reduction in both the frequency and severity of cerebral palsy for those infants surviving the immediate intrapartum time frame. The following points from these studies are important to note:

• Very preterm birth (less than 34 weeks) and very low birth weight (less than 1,500 g) are principal risk factors for cerebral palsy, making up between 17% to 32% of all cases of cerebral palsy.

• Evidence from population-based registries shows the prevalence of cerebral palsy is rising in very low birth weight infants.

• Recent retrospective studies confirm that the increasing prevalence of cerebral palsy is from higher rates in preterm, not term, infants.

The term neuroprotection is used to describe the possible indication for magnesium sulfate in these clinical situations. Although the results from the relevant studies are intriguing, one of the principal researchers for two of these studies suggests it is not yet time to recommend the routine use of magnesium sulfate for neuroprotective benefits in any circumstance of preterm labor (Crowther, 2002 [M]):

A meta-analysis involving individual patient data from the various trials might help to answer these ques-tions, better guide clinical-practice recommendations, and frame future research. Information from long-term follow-up of children whose mothers received antenatal magnesium sulfate also is needed to clarify the neuroprotective role of this therapy before preterm birth (Stanley, 2008 [R]).

Calcium channel blockers

Nifedipine is the drug most commonly employed from this class of medications for tocolysis. No placebo-controlled trials have evaluated the drug for this indication, but comparative trials have demonstrated the efficacy and safety of the drug (King, 2003 [M]; Papatsonis, 1997 [A]).

Beta-adrenergic-receptor agonists

Terbutaline is one of the commonly employed drugs from this class of medications for tocolysis. Avail-able studies show a prolongation of pregnancy similar to the results of calcium channel blockers, but no significant reduction in perinatal morbidity or mortality (Anotayanouth, 2004 [M]). However, the absence of such findings may be a result of the sample size in some of the trials analyzed.

Cyclooxygenase inhibitors

Indomethacin is the drug most commonly employed from this class of medications for tocolysis. A meta-analysis of three comparative trials with other classes of tocolytics showed a reduction of preterm births (< 37 week) (King, 2005 [M]). Indomethacin should only be used at less than 32 weeks gestation and only for 48 hours maximum to allow for the administration of antenatal corticosteroids (Doyle, 2005 [M]; Loe, 2005 [M]).

Maternal transfer to prevent the need for premature neonatal transfer reduces preterm neonatal morbidity and mortality. Very low birthweight infants (less than 1,500 grams) inborn to Level III perinatal centers have lower mortality, reduced incidence of Grade III and Grade IV intraventricular hemorrhage, and lower sensorineural disability rates than outborn infants (Menard, 1998 [C]; Towers, 2000 [C]; Yeast, 1998 [C]).

39. Broad Spectrum AntibioticsBroad-spectrum antibiotic coverage appears to lengthen the latency from preterm premature rupture of membranes (pPROM) until delivery and/or chorioamnionitis. Antibiotic therapy reduces maternal and neonatal morbidity in women with pPROM. There is no consensus on the choice of antibiotic or dose. A



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combination of ampicillin and erythromycin appears promising (Bar, 2000 [C]; Edwards, 2000 [C]; Kenyon, 2000 [M]; Mercer, 1997 [A]).

41. Stabilize on Tocolytics/Transfer Mother to Appropriate Level of Care if PossibleSee Annotation #37, "Stabilize on Tocolytics/Transfer Mother to Appropriate Level of Care if Possible," for a discussion about tocolytics.

42. Antenatal Corticosteroids 23-34 WeeksPlease refer to annotation #47, "Possibly Initiate Tocolytics, Antenatal Corticosteroids and Antibiotic Group B Streptococcus (GBS) Prophylaxis," for dosing of betamethasone and other corticosteroids.

47. Possibly Initiate Tocolytics, Antenatal Corticosteroids and Antibiotic Group B Streptococcus (GBS) ProphylaxisAgents to be considered for tocolytic therapy include terbutaline sulfate (including pump), indomethacin and nifedipine. In February 1997, the FDA alerted practitioners to use caution in the continuous subcutaneous administration of terbutaline sulfate.

Other considerations for initial management of preterm labor include the following:

• Initiate antenatal corticosteroids if 23-34 weeks gestation. Please refer below to "Pharmacologic Management of Preterm Labor" for more information on administration of betamethasone and other corticosteroids.

• Administer IV antibiotic effective against group B streptococcus (GBS) until GBS results are back or if patient is known to be positive for GBS (Thorp, 2002 [M]).

• Activity limitation as indicated.

• Order additional laboratory analysis pertinent to tocolytic being used.

Pharmacologic Management of Preterm LaborA. Tocolysis and betamethasone

Management of preterm labor should include parenteral tocolysis for 48 hours with administration of two doses of betamethasone.

The usual dosage regimen is betamethasone 12 mg IM STAT, then repeat in 24 hours.

An alternative medication is dexamethasone for a total of 24 mg (usual dosing regimen is 6 mg IM every 12 hours times four doses).

Treatment should be initiated in women with any symptoms or signs that might herald the onset of preterm delivery or a potential need for elective birth, rather than waiting until the diagnosis is in no doubt. While a single complete course of antenatal steroids provides significant multiple benefits to the preterm neonate, multiple courses should not be used. Please refer to the NIH Consensus Statement (Guinn, 2001 [A]; National Institutes of Health, 2000 [A]; Thorp, 2001 [A]).

Treatment should not be withheld because delivery appears to be imminent.

Antenatal corticosteroid therapy for fetal lung maturation reduces mortality, respiratory distress syndrome and intraventricular hemorrhage in preterm infants. These benefits extend to a broad range



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of gestational ages and are not limited by gender or race (Crowley, 2002 [M]). New data indicate that the benefits of postnatal surfactant are enhanced by antenatal corticosteroid administration. No adverse consequences to a policy of administration of antenatal steroids to women in preterm labor have been identified (American College of Clinical Pharmacy, 2000 [R]; American College of Obestricians and Gynecologists, The, 2002a [R]).

The beneficial effects of corticosteroids are greatest more than 24 hours after beginning treatment. However, treatment less than 24 hours in duration may improve outcome. Every effort should be made to treat women before spontaneous or elective preterm delivery.

Aggressive Management with TocolysisTocolysis should be continued if necessary until fetal lung maturity is documented or maternal or fetal complications arise for which preterm delivery is indicated.

The etiology of preterm labor remains obscure. Consequently, patients who continue to have regular uterine activity and/or gradual cervical changes on parenteral tocolysis must be managed with clinical judgment, balancing the risks to the mother of ongoing tocolysis against the risks of preterm birth for the neonate.

For additional information regarding tocolytic therapy, please refer to the following: (American College of Obstetricians and Gynecologists, The, 1989 [R]; National Institutes of Health Consensus Development Conference Statement, 1995 [R]; Ogburn, 1990 [R]; Sanchez-Ramos, 1999 [M]).

Terbutaline PumpSeveral well-designed studies have concluded that terbutaline administered by infusion pump may be a safe and effective treatment option for the prolongation of pregnancy. However, there continues to be debate in the medical literature concerning the safety and efficacy of the pump (Allbert, 1994 [C]; Elliott, 1997 [D]; Perry, 1995 [D]).

Another study (Elliott, 2004 [B]), concludes that continuous subcutaneous terbutaline infusion was associ-ated with an exremely low incidence of serious events.

B. Administer antibiotics for group B streptococcus (GBS) prophylaxis until GBS results are back. Please refer to the GBS prophylaxis guidelines at your institution (Hager, 2000 [R]).

The Agency for HealthCare Research and Quality reviewed literature on the use of antibiotics in preterm labor (Agency for HealthCare Research and Quality, 2000 [M]).

(Centers for Disease Control and Prevention, 2002 [R])

49. Vaginal Pool + Amnio at 32+ Weeks for Fetal Lung Maturity (FLM)Phosphatidyl glycerol (PG) is a reliable indicator of FLM if present in vaginal pool specimens. L/S ratio is unreliable if blood and/or meconium are present in the fluid. Certain assays of PG may be influenced by the presence of heavy growth of gardnerella vaginalis. Please consult with your local hospital clinical laboratory (Beazley, 1996 [R]).

Maternal chorioamnionitis and hospital length of stay were lessened with induction of labor in preterm premature rupture of membranes (pPROM) with mature fetal lung maturity studies after 32 weeks, with no difference in neonatal outcomes compared with expectant management (Mercer, 1993 [R]).



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51. Management of Preterm Labor with BleedingIn the presence of preterm labor with bleeding, IV access is essential.

• The patient should be on strict bedrest.

• Blood should be typed and crossmatched.

• Complete blood counts (CBCs) with platelets, prothrombin time (PT), partial thromboplastin time (PTT) and fibrinogen.

• Continue fetal monitoring while bleeding.

54. Deliver for Fetal Distress/Chorioamnionitis/Active Labor/34 Weeks PROM/Other Obstetrical IndicatorsUnder these conditions, we recommend delivery (Hauth, 2006 [M]).

A "break point" in neonatal morbidity was observed at 34 weeks gestation, which supports induction of labor at this gestional age (Neerhof, 1999 [B].

Vaginal Birth After Caesarean (VBAC) Algorithm Annotations

57. Special Considerations of Labor Management• Availability of a team capable of performing a Caesarean delivery within a short time (American College

of Obstetricians and Gynecologists, The Practice Bulletin, 2004 [R]).

• Review the prior operative report(s) to ensure that the uterine incision did not involve the contractile portion of the uterus such as a classical incision. A VBAC after a Caesarean with classical incision carries a tenfold higher risk of uterine rupture compared to a low transverse uterine incision.

• Intermittent auscultation or continuous electronic fetal heart rate monitoring should be done. See Intra-partum Fetal Heart Rate (FHR) Management algorithm and annotations.

• Augmentation or induction of labor with oxytocin increases the risk of uterine rupture (Blanchette, 2001 [C]) though the risk is still low (1%-2.4%). Oxytocin and prostaglandin were not individually associ-ated with uterine rupture except when sequential prostaglandin-oxytocin was used (Macones, 2005 [R]). A meta-analysis (Dodd, 2006 [R]) found sufficient evidence to help in choosing planned induction in VBAC versus elective repeat Caesarean delivery.

• The ACOG Committee on Obstetric Practice recommends that misoprostol not be used for induction of labor in women with prior Caesareans or major uterine surgery (American College of Obstetricians and Gynecologists, The, 2006 [R]).

• Use of the Foley bulb catheter has a uterine rupture rate close to that of women laboring spontaneously and has a VBAC success rate similar to that of women who have induced labor (Ravasia, 2000 [B]). The intracervical catheter ripening method does not stimulate uterine contractions, which is an advantage for women with previous Caesareans (Bujold, 2004 [B]). The Society of Obstetricians and Gynecologists of Canada has endorsed the use of the Foley bulb catheter for cervical ripening for women with a low transverse uterine scar. ACOG has no statement either endorsing or discouraging mechanical dilators for cervical ripening in women attempting VBAC (SOGC Clinical Practice Guidelines, 2005 [R]).



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60. Complicated Labor ManagementThe same considerations for intervention in labor apply to VBACs as for other attempted deliveries.

Complicated labor can be manifested in several categories:

• Failure to progress – the same considerations for intervention – including amniotomy, oxytocin, epidural anesthesia/analgesia – apply to VBACs. If indication for primary Caesarean was dystocia, percentage successful VBACs was 77%. Women who required oxytocin for induction had 58% successful vaginal delivery versus 88% who required oxytocin for augmentation (Sakala, 1990 [C]; Silver, 1987 [D]; Stovall, 1987 [D]).

• Fetal distress – see Intrapartum Fetal Heart Rate (FHR) Management algorithm and annotations.

• Maternal complications – pre-eclampsia and exacerbation of pre-existing maternal illness are managed similarly in complicated VBAC versus a complicated vaginal labor patient.

• Uterine rupture – the scarred uterus has an increased potential to rupture. Uterine rupture occurs in between 1/100 and 1/11,000 deliveries, depending on whose data one uses and the clinical presenta-tion. The type of scar makes a difference in frequency of rupture and severity of symptoms, also (LST 0.2-0.8 Classical 4.3-8.8, T4.3-8.8, Low Vertical 0.5-6.5) (Pridjian, 1992 [R]).

Rupture through a low segment transverse scar is much more likely to go undetected or produce maternal hypovolemia or gradual fetal distress. Complete rupture with expulsion of fetus or placenta is a true obstetric emergency and can lead to maternal or hypovolemic complication, even death, as well as fetal hypoxia and death.

Conditions that increase the risk for uterine rupture:

• Previous uterine injury, Caesarean delivery, myomectomy, etc.

• Intrapartum – hyperstimulation, difficult forceps, internal podalic versions, fundal pressure, etc.

• Uterine defects not related to trauma, e.g., congenital defect, invasive mole

• Multiple previous Caesarean deliveries

Signs and symptoms of uterine rupture include:

• Fetal distress – 50%-70% of detected ruptures present with abnormal FH tracings (e.g., variable decelerations that evolve into late decelerations)

• Uterine pain, especially pain over previous incision that continues between contractions

• Hemorrhage – intra-abdominal, vaginal or urinary

• Palpation of fetal parts

• Loss of contractions

• Recession of presenting part

• Fetal death

Uterine scar disruptions can be classified into three types:

• Scar dehiscence – Opening of previous scar, with intact overlying peritoneum (uterine serosa), no expulsion of uterine contents

• Incomplete rupture – Opening of previous scar, but not overlying peritoneum, extraperitoneal extru-sion of intrauterine contents



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• Complete rupture – Opening of previous scar and overlying peritoneum with extrusion of intrauterine contents into peritoneal cavity

(American College of Obstetrics and Gynecologists, 2006 [R]; Pridjian, 1992 [R])

Management of Labor Dystocia Algorithm Annotations

63. Labor Dystocia DiagnosisLabor abnormalities are classified as either protraction disorders (slower than normal progress) or arrest disorders (complete cessation of progress). Labor dystocia can only be defined when labor is in the active phase. Management of labor dystocia is especially important in the nulliparous woman to prevent unneeded Caesarean sections (Gifford, 2000 [D]).

Friedman provided the definition for "normal labor" in the 1950s. Further observation has shown that the definition of "normal labor" is broader than Friedman's definition. This has lead to more flexibility in the management of abnormal labor. Management strategies assume that mother and baby are doing well (including reassuring fetal monitoring).

65. Less than 1 cm Dilation for Two Consecutive Hours? Labor progress is measured by checking for cervical change using a digital cervical exam. Cervical exams should indicate at least one centimeter dilation per hour during the active phase. Frequent cervical checks afford the best opportunity to assess the progress of labor and to diagnose labor with abnormal progress.

At least one clinical trial testing the effectiveness of active management of labor in reducing Caesarean deliveries used hourly cervical exams; others studies have used every-two-hour exams. The "two-hour" rule for determining dilatation has been challenged. However, there is not enough supporting evidence to change our recommendation of "one-hour" cervical exams (American College of Obstetricians and Gynecologists, The Practice Bulletin, 2003a [R]; Frigoletto, 1995 [A]; Lopez-Zeno, 1992 [A]; Zhang, 2002 [C]).

66. Management of Protracted LaborProtracted labor is defined as labor which progresses more slowly than usual. "Active" management of labor as defined by O'Driscoll, et al does not reduce the rate of Caesarean delivery but may decrease the length of labor and increase patient satisfaction in nulliparas [Conclusion Grade II: See Conclusion Grading Worksheet B – Annotation #66 (Management of Protracted Labor)] (DeMott, 1992 [C]; Glantz, 1997 [M]; Harman, 1999 [R]; MN Clinical Comparison and Assessment Project, 1991 [R]; O'Driscoll, 1984 [C]).

Management of protraction disorders includes (Frigoletto, 1995 [A]; Lopez-Zeno, 1992 [A]; Sadler, 2000 [A]:

• Evaluation of the potential causes:

- Power: hypocontractile uterine activity is the most common cause of first stage of labor abnor-malities. Adequate contractions are defined as a minimum of 200 Montevideo units in 10 minutes.

- Passenger: check for malposition, malpresentation, macrosomia.

- Passageway: is pelvis adequate? Is there cephalopelvic disproportion?



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Consider:

• IV fluids (IV fluids 150 cc/hr may decrease the need for oxytocin augmentation) (Garite, 2000 [A].

• Artificial rupture of membranes if membranes are intact and there are no contraindications. (See Annotation #11, "Intrapartum Care.")

Amniotomy may be used to enhance progress in active labor (may decrease length of labor and decrease the need for oxytocin augmentation), but may increase the rate of maternal fever. First-stage amniotomy should be reserved for slowly progressing labors (Fraser, 2000 [M]).

• Discontinuing or reducing epidural anesthesia, as the use of epidurals has been shown to increase the length of labor. However, there is no increased rate of Caesarean birth for dystocia when epidural anesthesia is in use (King, 1997 [R]; Rogers, 1999 [C]).

• Oxytocin augmentation. The use of low-dose or high-dose dosing regimens has been shown to shorten labor by hours (Hinshaw, 2008 [A].

Contraindications to oxytocin augmentation include:

• unknown presentation or floating/unstable,

• patient refusal, and

• inability to monitor contractions adequately.

• Obtain an obstetrical/surgical consult if necessary. Caesarean delivery is performed when there is an arrest of labor: patient has not made progress for two to four hours after strength of contractions deemed adequate (regardless of oxytocin dosage or duration of oxytocin).

Extending time of observation to four hours before operative treatment has been shown to decrease the Caesarean delivery rate for arrested labor (Rouse, 2001 [A]). Although studies of single aspects of "active" management of labor have not demonstrated a decrease in the rate of Caesarean delivery, an analysis of the literature suggests that some combination of active management techniques will lead to an overall decrease in the rate of Caesarean delivery (Turner, 1988 [C]).

71. Fetal Head Descent Greater than 1 cm/Hour? When the patient has reached Stage II labor, a reassessment at least every 30 minutes for two consecutive hours is done to assess descent of the fetus and rotation of the fetus. If the patient is making appropriate progress, the caregiver can anticipate vaginal delivery. Fetal descent should be greater than 1 cm per hour.

If labor is not progressing, consider an internal monitor to measure strength of uterine contractions. After two hours of internal monitoring there should be enough evidence to determine if patient is making progress (Harbert, 1992 [R]).

Relative contraindications to direct, invasive monitoring include chorioamnionitis, active maternal genital herpes infection and HIV infection, certain fetal presentations and conditions that preclude vaginal examinations such as placenta previa or undiagnosed vaginal bleeding (Association of Women's Health Obstetrics and Neonatal Nurses, 2003 [R]).



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73. Management of Protracted Labor If the patient in Stage II labor is not making progress, management of protraction disorders will include:

• Evaluation of maternal and fetal position. Consider having the patient move into different posi-tions.

• Oxytocin augmentation.

• Allowing fetus to "labor down." Do not start active pushing as soon as patient is fully dilated. Allow contractions to move the baby down (Fraser, 2000a [A]).

• Decreasing or stopping epidural anesthesia. Epidural anesthesia is associated with a prolongation of the second stage of labor and an increase in oxytocin use and assisted vaginal delivery (Shields, 2007 [R]).

• Evaluation of fluid balance may be beneficial for affecting labor progress (American College of Obstetricians and Gynecologists, The, 2003 [R]).

• Consideration of assisted delivery.

• OB/surgical consult if necessary.

(Minnesota Clinical Comparison and Assessment Project, 1991 [R]; Saunders, 1992 [B])

74. Is the Head Descending?Prolongation of the second stage of labor beyond an arbitrary time limit is no longer an indication for assisted vaginal or Caesarean delivery. As long as progress is being made and fetal monitoring is reassuring, the patient can continue pushing (Cheng, 2004 [A]; Myles, 2003 [B]).

75. Assisted Vaginal Delivery Indicated? If there is no descent for two hours despite optimizing labor, an assisted delivery or surgical consult is suggested. Vacuum extraction or mid/low forceps delivery contraindications include:

• vertex is too high,

• provider is inexperienced,

• fetal distress with inability to do timely operative vaginal delivery, and

• patient refusal.

Note: When using vacuum extraction or forcep application with a suspected macrosomic infant, be aware of the risk of shoulder dystocia.

(O'Driscoll, 1984 [C]; Rouse, 2001 [D]; Shields, 2007 [R])

Intrapartum Fetal Heart Rate (FHR) Monitoring Algorithm Annotations

78. Continuous EFM-ext or EFM-int (if needed) Electronic fetal monitoring (EFM) is indicated in all high-risk situations and in low-risk situations when the auscultatory pattern is unclear or when 1:1 nursing staff is not available. Internal EFM may allow easier patient positioning and promote patient activity by being less confining than external EFM. Low-risk patients should be encouraged to be as active and mobile as possible.



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80. FHR Pattern Is Predictive of Normal Acid-Base Status? All obstetrical nurses, nurse midwives and physicians must achieve competence and confidence in fetal heart rate monitoring and FHR pattern analysis. Based on careful review of the available options, a three-tier system for the categorization of FHR patterns is recommended. Fetal heart rate tracing patterns can provide information on the current acid-base status of the fetus but cannot predict the development of cerebral palsy. Categorization of the FHR tracing evaluates the fetus at that point in time; tracing patterns can and will change (Macones, 2008 [R]).

Category of

FHR Pattern

Interpretation

Baseline and

Variability

Accelerations

(15 x 15)

Decelerations Interventions

Category I:

strongly

predictive of

normal fetal acid-

base status

• BL 110-160

• Moderate

variability

• Present or

absent

+/- Early decels

• No variable or

late decelerations

No specific

interventions

required, ongoing

assessment and

evaluation.

Category II:

Indeterminate.

Not predictive of

abnormal fetal

acid-base status

• BL < 110

without absent

variability

• BL > 160

• Marked

variability

• Absent

variability

without

decelerations

• Absence of

accelerations

after fetal

stimulation

• Prolonged

decelerations

(> 2 minutes but

< 10 minutes)

• Recurrent late

decels with

moderate

variability

• Recurrent variable

decels with

minimal or

moderate

variability

Requires evaluation

and continued

surveillance. Review

and take into account

associated clinical

circumstances.

Category III:

Predictive of

abnormal fetal

acid-base status at

the time of

observation

• Absent

variability and

any of the

following:

• Recurrent late

decels

• Recurrent

variable decels,

• BL < 110

• Sinusoidal

pattern

Prompt evaluation

and management

indicated. May

include:

• Maternal position

change

• Maternal oxygen

• Discontinuation of

labor stimulus

• Treatment of

possible underlying

condition

• Expedited delivery

Developed by the guideline committee.

Source: American College of Obstetricians and Gynecologists, The, 2005 and Macones, 2008

Definitions:

Late decelerations

• Deceleration is delayed in timing, onset-to-nadir if the deceleration is 30 seconds or greater, and there is a gradual decrease and return to baseline.



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Early decelerations

• Onset, nadir and recovery mirror the beginning, peak and ending of the contraction.

Variable decelerations

• Abrupt decrease in the FHR with onset to nadir of deceleration reached in less than 30 seconds, decrease in FHR is 15 seconds or greater and less than two minutes in duration.

Variability

• Fluctuations in the FHR baseline over a 10-minute window, accelerations and decelerations are not included in the range.

• Absent - amplitude range is undetectable.

• Minimal - amplitude range is between 2 beats per minutes (bpm) and 5 bpm.

• Moderate - amplitude range is between 6 bpm and 25 bpm.

• Marked - amplitude range is greater than 25 bpm.

Recurrent

• Decelerations that occur with 50% or greater of uterine contractions in any 20-minute window.

Sinusoidal pattern

• Cyclic, smooth, sine wavelike undulating pattern in the FHR baseline frequency cycle of 3-5 per minute that persists for 20 minutes or longer.

(American College of Obstetricians and Gynecologists, The, 2005 [R]; Macones, 2008 [R])

82. Assessment and Remedial Techniques A persistent Category II or Category III FHR tracing requires evaluation of the possible causes. Initial evaluation and treatment may include:

• discontinuation of any labor stimulating agent;

• cervical examination to assess for umbilical cord prolapse or rapid cervical dilation or descent of the fetal head;

• changing maternal position to the left or right lateral recumbent position, reducing compression of the vena cava and improving uteroplacental blood flow;

• monitoring maternal blood pressure level for evidence of hypotension, especially in those with regional anesthesia (if present, treatment with ephedrine or phenylephrine may be warranted);

• assessment of patient for uterine hyperstimulation by evaluating uterine contraction frequency and duration; and

• amnioinfusion – indications for therapeutic amnioinfusion include repetitive severe variable decel-erations and prolonged decelerations (Fraser, 2005 [A]; Miyazaki, 1985 [A]; Rinehart, 2000 [A]). Amnioinfusion for thick meconium is no longer recommended.

(American College of Obstetricians and Gynecologists, The Practice Bulletin, 2005 [R])



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86. Further FHR Assessment Predictive of Normal Acid-Base Status? Obtain obstetrical or surgical consultation or referral where needed to plan for operative delivery if the FHR pattern is Category III. Category III tracings are predictive of fetal academia. Consider contacting a neonatology team to plan for possible neonatal intervention.

Scalp stimulation or vibroacoustic testing may be used for further fetal assessment. A 15-beat-per-minute rise in FHR lasting 15 seconds from the beginning to the end of the acceleration in response to scalp stimu-lation or to vibration or sound is predictive of normal fetal acid-base status. If the scalp stimulation test or vibroacoustic test response is abnormal, immediate delivery is indicated.

Other tests to assess fetal acid-base status may be helpful if available. This includes fetal scalp sampling for PH. A scalp pH greater than 7.19 is a positive result (Skupski, 2002 [M]; Smith, 1986 [D]).

However, proper FHR pattern interpretation and the response to scalp stimulation or vibroacoustic stimula-tion can allow the clinician to detect tracings predictive of abnormal feta acid-base status.

Knowledge of the fetal oxygen saturation is not associated with a reduction in the rate of Caesarean delivery or with improvement in the condition of the newborn (Bloom, 2006 [A]).

87. Emergent Delivery Tracings predictive of abnormal fetal acid-base status (Category III) indicate the need for emergent delivery. Delivery should be affected by appropriate means, depending on the clinical situation. This may include vacuum extraction, forceps or Caesarean delivery, depending upon fetal presentation and the expertise of the attending physician(s).

Caesarean delivery should be performed if vacuum extraction or forceps are inappropriate for use.

If a Caesarean delivery is performed, the suitability of a VBAC in a subsequent pregnancy should be discussed with the patient.

The following are indications for Caesarean birth based on abnormal FHR monitoring, according to the Minnesota Clinical Comparison and Assessment Project:

• Late decelerations that comprise the majority of contractions over a minimum 20-minute period in the absence of adequate beat-to-beat variability and that do not respond to remedial techniques.

• Severe variable decelerations that comprise the majority of contractions over 20-60 minutes and that do not respond to remedial techniques.

• Severe persistent non-remediable bradycardia.

• Scalp pH less than 7.2 or negative FHR acceleration test (confirmation in 15-20 minutes recom-mended).

• There may be other combinations or non-remediable patterns that may not meet severity criteria listed above that may be indications for preparation for Caesarean birth. A scalp pH or FHR acceleration test (scalp or acoustic) may help clarify the issue. Consultation or second opinion is suggested.

• In the second stage of labor, depending on the judgment and skill of the physician, operative vaginal delivery may be the least hazardous for the mother and child.

If one-minute APGAR is less than three, or five-minute APGAR is less than six, cord pH or gases are recommended. Cord pH is a better indicator than APGAR for fetal compromise. A segment of umbilical cord is isolated with clamps and may be stored up to 60 minutes after delivery with reliable umbilical artery pH determination. The segment does not need to be heparinized or placed on ice (Duerbeck, 1992 [D]; Johnson, 1993 [D]).



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Appendix A – Patient Education Handout


ACTIVE MANAGEMENT OF LABORIs active management of labor for you?

This is for you if you are going to be giving birth for the first time, you are healthy and are within three weeks of your due date, and the baby is in the usual head-down position.

This is not for you if you have delivered a baby before, or if you are having your labor induced (started) in the hospital, or if you are expecting more than one baby.

Why is active management of labor used?

Active management of labor is a method of intervention that prevents labor from lasting too long. Prolonged labor increases a woman's risk of exhaustion, infection, hemorrhage after delivery and need for Caesarean delivery.

Recent studies in both the United States and abroad have demonstrated clear benefits of this intervention. Active management of labor does not cause any increased risks to the baby.

How is active management of labor used?

It begins when you are admitted to the hospital in labor, and you are having regular contractions at least every five to seven minutes. When your cervix is effaced (thinned out) and dilated to 3 centimeters or more, your care provider will check if your membranes have ruptured (water has broken). If not, the membranes will be opened unless the baby's head is too high. This procedure is known as an "amniotomy." The amniotic fluid will then start to leak out. This procedure may be enough to keep your labor progressing and prevent it from lasting a long time.

During your labor, you will need to have a vaginal exam every two hours or so to check your progress. If your cervix continues to dilate at least one centimeter or more per hour, your labor is making normal progress.

If your labor progress stalls and your cervix changes too slowly (less than 1 centimeter in two hours), your labor will be augmented with a medication, oxytocin.

Oxytocin (Pitocin) Augmentation

Pitocin is a synthetic hormone that helps to increase the strength of the contractions and make them more effective. It is given through an intravenous (IV) drip and the amount is carefully monitored.

A fetal monitor will be used to follow the baby's heartbeat and record the contractions.

You will still be able to move around and change positions for your own comfort. You can certainly also receive pain relief as needed.

Failure to Progress

If following this labor management plan does not progress to vaginal delivery, you will need a Caesarean delivery. Active management does not increase your chances of failure to progress; however, it can shorten the time between the beginning of your labor and when the decision is made for a Caesarean delivery. This can help in your recovery from surgery.


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The third stage of labor (delivery of placenta)

Following delivery of the baby, oxytocin can be given to help your uterus contract to deliver the placenta and control bleeding. This can be given through your intravenous drip (if you have one) or as a shot. Studies have shown that this management reduces the rate of heavy bleeding after delivery, anemia (low iron in the blood) and the need for blood transfusion.

How do women like active management of labor?

Many women like having an idea of knowing how long their labor will last and knowing that it will not last too long. After delivery, they have more energy to enjoy their baby and to get breast-feeding off to a good start.

This information is meant to enhance but not replace what you learn in childbirth education classes. Child-birth education classes are highly recommended.

Please discuss further questions with your pregnancy care provider during your prenatal visits.

Management of Labor Appendix A – Patient Education Handout Third Edition/May 2009

30Copyright © 2009 by Institute for Clinical Systems Improvement

Released in May 2009 for Third Edition. The next scheduled revision will occur within 24 months.

Contact ICSI at: 8009 34th Avenue South, Suite 1200; Bloomington, MN 55425; (952) 814-7060; (952) 858-9675 (fax)

Online at http://www.ICSI.org


Document Drafted Jul – Sep 2005

First Edition Nov 2005

Second Edition Apr 2007

Third Edition Begins Jun 2009

Supporting Evidence:

Management of Labor

Original Work Group MembersThe Management of Labor guideline is the result of merging the Preterm Birth Prevention (Preterm), Intrapartum Fetal Heart Rate Monitoring (IFHRM), The Prevention, Diagnosis and Treatment of Failure to Progress in Obstetrical Labor (FTP), and Vaginal Birth after Caesarean (VBAC) guidelines.

Health EducationDianne Eggen, RN, MPH – PretermHealthPartnersFamily PracticeGreg Angstman, MD – IFHRMMayo ClinicAndy Bock, MD – FTPMayo ClinicDonald Lum, MD – VBACRiverValleyClinicofNorthfieldCarol Stark, MDMinnHealth Family PhysiciansNurse MidwifeSandy Lindell – IFHRMTwin City OB/Gyn, Ltd.Debra Monson, CNM – VBACTwin City OB/Gyn, Ltd.Mary Jo Rourke, CNM – FTPGroup Health, Inc.Nurse PractitionerJulie Rice, RN, NP – PretermHealthSystem MinnesotaOB/GYNDale Akkerman, MD – VBACPark Nicollet Medical Center

Work Group Leaders John Farr, MD – FTPOB/Gyn Twin City OB/Gyn, Ltd.John Hering, MD – VBACObstetricianGroup Health, Inc.Peter Mark, MD – PretermOB/GynHealthPartnersLeslie Pratt, MD – PretermOB/GynHealthSystem MinnesotaDeborah Thorp, MD – IFHRMOB/GynPark Nicollet Medical CenterBusiness Health Care Action GroupKathy Halvorsen, RN – VBACHoneywell Inc.Terry Kent, RN, MS – PretermHoneywell, Inc.Marcia McCarty – FTPTarget StoresAnne Widtfeldt – IFHRMHoneywell, Inc.

John Hachiya, MD – FTPPark Nicollet Medical CenterJaved Malik, MD – FTPGroup Health, Inc.Paul Ogburn, MD – VBAC, PretermMayo ClinicCharles Stegeman, MD – IFHRMGroup Health, Inc.John Underwood, MD – IFHRMCoon Rapids Medical CenterMeasurement AdvisorRick Carlson – FTP, IFHRM, VBACGroup Health, Inc.Leif Solberg, MD – PretermGroup Health FoundationFacilitatorsKatie Conlin, RN, MPH – VBACGroup Health, Inc.Stacie Emberley, RN – VBACICSIBrenda Gorder, RN – FTPGroup Health, Inc.Jackie Rikhus, RN – PretermICSI


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Individual research reports are assigned a letter indicating the class of report based on design type: A, B, C, D, M, R, X.

A full explanation of these designators is found in the Foreword of the guideline.

II. CONCLUSION GRADES

Key conclusions (as determined by the work group) are supported by a conclusion grading worksheet that summarizes the important studies pertaining to the conclusion. Individual studies are classed according to the system defined in the Foreword and are assigned a designator of +, -, or ø to reflect the study quality. Conclusion grades are determined by the work group based on the following definitions:

Grade I: The evidence consists of results from studies of strong design for answering the question addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative results have sufficiently large samples to have adequate statistical power.

Grade II: The evidence consists of results from studies of strong design for answering the question addressed, but there is some uncertainty attached to the conclusion because of inconsistencies among the results from the studies or because of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the question addressed, but the results have been confirmed in separate studies and are consistent with minor exceptions at most.

Grade III: The evidence consists of results from studies of strong design for answering the question addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among the results from different studies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering the question addressed.

Grade Not Assignable: There is no evidence available that directly supports or refutes the conclu-sion.

The symbols +, –, ø, and N/A found on the conclusion grading worksheets are used to designate the quality of the primary research reports and systematic reviews:

+ indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias, generaliz-ability, and data collection and analysis;

– indicates that these issues have not been adequately addressed;

ø indicates that the report or review is neither exceptionally strong or exceptionally weak;

N/A indicates that the report is not a primary reference or a systematic review and therefore the quality has not been assessed.

Brief Description of Evidence Grading System



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Management of Labor References Third Edition/May 2009


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Thorp JA, Jones AMH, Hunt C, Clark R. The effect of multidose antenatal betamethasone on maternal and infant outcomes. Am J Obstet Gynecol 2001;184:196-202. (Class A)

Towers CV, Bonebrake R, Padilla G, Rumney P. The effect of transport on the rate of severe intraven-tricular hemorrhage in very low birthweight infants. Obstet Gynecol 2000;95:291-95. (Class C)

Turner MJ, Brassil M, Gordon H. Active management of labor associated with a decrease in the Caesarean delivery rate in nulliparas. Obstet Gynecol 1988;71:150-54. (Class C)

Vendittelli F, Volumenie J. Transvaginal ultrasonography examination of the uterine cervix in hospitalised women undergoing preterm labour. Eur J Obstet Gynecol Reprod Biol 2000;90:3-11. (Class R)

Vintzileos AM, Antsaklis A, Varvarigos I, et al. A randomized trial of intrapartum electronic fetal heart rate monitoring versus intermittent auscultation. Obstet Gynecol 1993;81:899-907. (Class A)

Vintzileos AM, Nochimson DJ, Guzman ER, et al. Intrapartum electronic fetal heart rate monitoring versus intermittent auscultation: a meta-analysis. Obstet Gynecol 1995;85:149-55. (Class M)

Yeast JD, Poskin M, Stockbauer JW, Shaffer S. Changing patterns in regionalization of perinatal care and the impact on neonatal mortality. Am J Obstet Gynecol 1998;178:131-35. (Class C)

Zhang J, Troendle JF, Yancey MK. Transactions of the twenty-second annual meeting of the society for maternal-fetal medicine: reassessing the labor curve in nulliparous women. Am J Obstet Gynecol 2002;187:824-28. (Class C)



www.icsi.org

40

Conclusion Grading Worksheet A – Annotation #20 (Bacterial Vaginosis)


Work

Grou

p's

Con

clu

sion

: T

reat

men

t of

bac

teri

al v

agin

osi

s in

fect

ion i

n p

regnant

wom

en a

t hig

h r

isk f

or

pre

term

del

ivery

by

trad

itio

nal

sev

en-d

ay c

ours

es o

f th

erap

y e

arly

in p

regnan

cy a

ppea

rs t

o r

educe

pre

term

del

iver

y.

Con

clu

sio

n G

rad

e:

II

Work

Grou

p's

Con

clu

sion

: T

he

evid

ence

reg

ardin

g t

reat

men

t of

low

-ris

k,

pre

gnan

t w

om

en w

ith a

sym

pto

mat

ic b

acte

rial

vag

i-nosi

s is

lim

ited

by u

se o

f in

adeq

uat

e th

erap

y i

n t

he

avai

lable

stu

die

s.

Con

clu

sio

n G

rad

e:

Gra

de

Not

Ass

ignab

le

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Mo

rale

s,

Sch

orr

, &

Al-

bri

tto

n (

19

94

)

RC

T

A

ø

-Wo

men

wit

h a

sin

gle

ton

ges

ta-

tio

n a

t 1

3-2

0 w

eek

s; p

rete

rm d

e-li

ver

y i

n p

reced

ing

pre

gn

ancy

;

po

siti

ve

for

BV

; n

o e

vid

ence

of

tric

ho

mo

na

infe

cti

on

-E

xcl

ud

ed:

con

gen

ital

ano

ma-

lies

; si

gn

ific

ant

mate

rnal

com

-p

licati

on

s; d

ocu

men

ted

co

cain

e

use

; in

com

pete

nt

cer

vix

lik

ely

; p

rio

r d

ocu

men

ted

in

tra-

am

nio

tic

or

uri

nar

y t

ract

infe

ctio

n r

esu

lt-

ing

in

pre

term

bir

th;

2n

d t

rim

es-

ter

ble

edin

g,

asy

mp

tom

atic

bac

-te

riu

ria

on

in

itia

l sc

reen

-R

and

om

ized

to

rece

ive

25

0 m

g

met

ron

idaz

ole

(3

X/d

ay f

or

7

day

s) o

r v

itam

in C

tab

let

-Pat

ien

ts i

n P

TL

rec

eiv

ed I

V

mag

nes

ium

su

lfate

an

d,

if t

hat

fa

iled

, o

ral

ind

om

eth

acin

(m

ain

-ta

ined

on

ora

l te

rbu

tali

ne)

-94

en

roll

ed:

14

su

bse

qu

entl

y e

xclu

ded

fro

m a

naly

-si

s (5

lo

st t

o f

oll

ow

-up

, 6

fai

led

to

co

mp

lete

tre

at-

men

t, 3

req

uir

ed t

reatm

ent

for

ren

al

or

pu

lmo

nar

y

dis

eas

e)

-44

of

the

rem

ain

ing

80

wer

e tr

eat

ed w

ith

metr

oni-

daz

ole

, 3

6 w

ith

pla

ceb

o

-Gro

up

s w

ere

sim

ilar

at

bas

eli

ne i

n a

ge, p

arit

y, ra

ce,

sm

ok

ing

sta

tus,

sp

on

tan

eou

s ab

ort

ion

s, p

rete

rm

bir

ths,

ou

tco

me o

f p

enu

ltim

ate

pre

gn

ancy

, fi

rst

tri-

mes

ter

ble

edin

g

-Metr

on

idazo

le g

rou

p h

ad f

ewer

ho

spit

al

adm

issi

on

s fo

r p

rete

rm l

abo

r, f

ewer

wit

h >

1 h

osp

ital

adm

issi

on

, fe

wer

wit

h g

esta

tio

nal

ag

e a

t d

eliv

ery

of

<3

7 w

eek

s,

few

er w

ith

bir

th w

eig

ht

<2

50

0g

, an

d f

ewer

wit

h

PR

OM

(al

l p

<0

.05

)

-In

a v

ery

hig

h-r

isk

gro

up

of

pati

ents

wit

h a

p

rem

atu

re d

eliv

ery

in

th

e p

rece

din

g p

reg

-n

ancy

, th

e t

reatm

ent

of

bac

teri

al

vag

ino

sis

and

per

hap

s ele

vate

d v

agin

al p

H i

n t

he

sec-

on

d t

rim

este

r w

ou

ld r

esu

lt i

n a

su

bst

anti

al

red

uct

ion

of

recu

rren

t p

rete

rm b

irth

s fr

om

ei

ther

id

iop

ath

ic p

rete

rm l

abo

r o

r P

RO

M.

NO

TE

S:

did

sam

ple

siz

e e

stim

atio

n –

wit

h

40

% r

isk

of

pre

mat

uri

ty, a s

amp

le s

ize o

f 4

5

per

gro

up

was

nee

ded

to

dete

ct

at

leas

t a

40

% r

edu

cti

on

in

pre

matu

rity

wit

h 8

0%

p

ow

er a

t 0

.05

lev

el


www.icsi.org

41

Conclusion Grading Worksheet A – Management of Labor Annotation #20 (Bacterial Vaginosis) Third Edition/May 2009

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

McG

reg

or,

et

al.

(19

95

) N

on

R

an-

do

m

C

ø

-Wo

men

in

itia

tin

g p

ren

atal

car

e -P

has

e I-

ob

serv

atio

n:

7 m

on

ths,

w

om

en e

xam

ined

fo

r p

anel

of

low

er r

epro

du

ctiv

e tr

act

mic

ro-

org

anis

ms

& s

ele

cted

vag

inal

enzy

mes

at

1st p

ren

atal

vis

it, 2

2-

29

wk

s g

esta

tio

n,

afte

r 3

2 w

ks

ges

tati

on

; tr

eat

men

t p

rov

ided

fo

r N

. g

on

orr

hea

, C

. tr

ach

om

a-

tis,

sy

ph

ilis

, &

uri

nar

y t

ract

in

-fe

ctio

n;

no

tre

atm

ent

un

less

co

mp

lain

ts o

r sy

mp

tom

s fo

r B

V,

T.

vag

ina

lis,

an

d y

eas

t -P

has

e II

: 8

mo

nth

s; i

den

tical

scre

enin

g a

nd

sam

pli

ng

, tr

eat

-m

ent

for

N. g

on

orr

hea

, C

. tr

a-

cho

ma

tis,

T.

vag

ina

lis,

BV

, y

east

& g

rou

p B

str

epto

cocc

al

bac

teri

uri

a

-Tre

atm

ent

of

BV

was

clin

-d

amy

cin

(3

00

mg

ora

lly

2X

/day

for

7 d

ays)

-61

4 e

nro

lled

in

Ph

ase

I, 6

40

in

Ph

ase

II;

anal

ysi

s b

ased

on

55

9 i

n P

has

e I

, 5

79

in

Ph

ase I

I (s

ee

NO

TE

S)

-Ph

ase

I an

d I

I g

rou

ps

wer

e s

imil

ar i

n a

ge,

eth

nic

ity

, m

arit

al

stat

us,

med

ical

his

tory

, sm

ok

ing

, d

rug

use

&

ante

nat

al f

act

ors

; B

V w

as p

rese

nt

in 3

1%

of

Ph

ase I

an

d 3

4%

of

Ph

ase

II p

atie

nts

-Sp

on

tan

eou

s ab

ort

ion

s at

<2

2 w

ks

occ

urr

ed i

n 2

%

of

Ph

ase I

an

d 3

% o

f P

has

e II

pat

ien

ts;

asso

cia

ted

w

ith

BV

at

enro

llm

ent

(RR

=3

.1, 9

5%

CI:

1.4

-6.9

) -P

rete

rm b

irth

in

13

% o

f P

hase

I a

nd

10

% o

f P

has

e II

pat

ien

ts (

NS

) b

ut

rate

of

pre

term

bir

th a

fter

id

io-

pat

hic

pre

term

lab

or

was

red

uce

d i

n P

has

e II

(R

R=

0.4

8;

95

%C

I: 0

.27

-0.8

8)

-Bir

thw

eig

hts

an

d r

ate

s o

f p

rete

rm b

irth

aft

er P

RO

M

or

for

med

ical

com

pli

cati

on

s d

id n

ot

dif

fer

-Ph

ase

I:

BV

ass

ocia

ted

wit

h i

ncr

eas

ed r

isk

of

pre

-te

rm b

irth

(R

R=

1.9

; 9

5%

CI:

1.2

-3.0

) &

pre

term

P

RO

M (

RR

=3

.5;

95

%C

I 1

.4-8

.9)

-Ph

ase

II p

ati

ents

had

red

uce

d r

ates

of

pre

term

bir

th

(vs.

Ph

ase

I, p

=0

.02

)

-In

Ph

ase I

(ri

sk o

f p

rete

rm b

irth

), w

ith

T.

vag

ina

lis

on

ly,

RR

=1

.4;

wit

h B

V o

nly

, R

R=

2.1

; w

ith

T.

vag

i-n

ali

s an

d B

V,

RR

=3

.3

-Tre

atm

ent

of

BV

(p

has

e II

) re

du

ced

ris

ks

of

pre

-te

rm b

irth

(2

5%

) to

rat

es s

imil

ar t

o t

ho

se a

mo

ng

B

V-n

egati

ve

wo

men

wit

h a

pri

or

pre

term

bir

th

-Mu

ltip

le l

og

isti

c r

egre

ssio

n i

nd

icate

d t

hat

BV

(OR

=1

.6;

95

%C

I: 1

.1-2

.4)

was

ass

ocia

ted

wit

h r

isk

o

f p

rete

rm b

irth

-O

ral

clin

dam

yci

n w

as e

ffec

tiv

e fo

r 9

3%

of

wo

men

w

ith

BV

at

the 2

-4 w

k f

oll

ow

-up

-Wo

men

wit

h B

V h

ad i

ncr

ease

d o

ccu

rren

ces

o

f sp

on

tan

eou

s p

reg

nan

cy l

oss

, p

rete

rm

PR

OM

, id

iop

ath

ic p

rete

rm b

irth

, an

d o

ver

all

p

rete

rm b

irth

. S

yst

em

ati

c cl

inic

al

scre

enin

g

and

sta

nd

ard

ized

tre

atm

ent

of

wo

men

wit

h

BV

wer

e a

sso

ciate

d w

ith

a 5

0%

red

ucti

on

in

b

oth

pre

term

bir

th a

nd

pre

term

PR

OM

.

NO

TE

S:

did

sam

ple

siz

e e

stim

atio

n –

wit

h

pre

term

bir

th r

ate

of

13

%,

esti

mate

d t

hat

56

4

wo

men

wo

uld

nee

d t

o b

e st

ud

ied

in

eac

h

ph

ase

to d

ete

ct

a 5

0%

red

ucti

on

in

th

e r

ate

of

pre

term

bir

th w

ith

po

wer

of

80

% a

t 0

.05

lev

el;

ex

clu

ded

th

ose

wit

h n

o p

reg

nan

cy

ou

tco

me d

ata

; al

so e

xcl

ud

ed 3

wh

o h

ad

ther

apeu

tic

abo

rtio

ns

(Ph

ase

I),

1 n

on

pre

g-

nan

t w

om

an (

Ph

ase I

I), w

om

en w

ith

mu

lti-

ple

ges

tati

on

s (4

Ph

ase

I, 1

3 P

hase

II)

; lo

st

or

exclu

ded

pati

ents

dif

fere

d f

rom

th

ose

in

fi

nal

an

aly

sis

in e

thn

ic g

rou

p, 1

st t

rim

este

r

ble

edin

g, re

po

rt o

f tr

aum

a o

r in

jury

du

rin

g

pre

gn

ancy

, ea

rlie

r en

roll

men

t fo

r p

ren

atal

ca

re


www.icsi.org

42


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

McD

on

ald

, et

al.

(19

97

) R

CT

A

–

-S

cree

ned

fo

r B

V f

lora

(G

. va

gi-

na

lis)

an

d B

V a

t 1

6-2

6 w

eek

s at

4 S

ou

th A

ust

rali

a p

erin

ata

l ce

n-

ters

; as

ym

pto

mati

c w

om

en w

ere

inv

ited

to

en

roll

-R

and

om

ized

to

pla

ceb

o o

r o

ral

met

ron

idaz

ole

(4

00

mg

, 2

X/d

ay

for

2 d

ays)

-E

xcl

ud

ed:

mu

ltip

le p

reg

nan

cy,

< 1

7 y

rs o

ld,

in v

itro

fer

tili

za-

tio

n,

all

erg

y t

o m

etr

on

idazo

le,

sym

pto

mat

ic B

V, ru

ptu

red

m

emb

ran

es,

cer

vic

al

cerc

lag

e,

insu

lin

-dep

end

ent

dia

bete

s, p

la-

cen

ta p

raev

ia,

anti

bio

tic

tx f

or

vag

init

is i

n p

ast

2 w

ks,

lan

gu

age

dif

ficu

ltie

s, u

nab

le t

o a

tten

d

clin

ic a

fter

4 w

ks

of

tx

-9,4

07

wer

e sc

reen

ed;

2,4

90

wer

e p

osi

tiv

e; 1

,73

4

wer

e el

igib

le f

or

enro

llm

ent;

87

9 (

51

%)

wer

e en

-ro

lled

-4

39

rec

eiv

ed m

etr

on

idazo

le;

44

0 r

ecei

ved

pla

ceb

o

-Gro

up

s si

mil

ar a

t b

asel

ine

in r

ace,

mate

rnal

ag

e a

t en

roll

men

t, l

ow

so

cio

eco

no

mic

sta

tus,

pri

mi-

gra

vid

a, p

rev

iou

s p

rete

rm b

irth

, g

est

atio

n;

mo

re <

20

yrs

at

enro

llm

ent

in p

lace

bo

gro

up

(p

<0

.01

) -C

om

pli

ance

81

% i

n t

reat

men

t g

rou

p, 8

3%

in

pla

-ce

bo

gro

up

; 1

89

in

tre

atm

ent

gro

up

an

d 2

36

in

pla

-ce

bo

gro

up

to

ok

sec

on

d c

ou

rse

of

treatm

ent;

11

in

tr

eatm

ent

gro

up

an

d 1

6 i

n p

laceb

o g

rou

p b

ecam

e sy

mp

tom

atic

(&

giv

en a

7-d

ay c

ou

rse o

f tr

eatm

ent)

-C

um

ula

tiv

e e

ffic

acy

of

metr

on

idazo

le f

or

treat

men

t

of

BV

was

75

%

-Pre

term

bir

th (

<3

7 w

ks)

in

7.2

% o

f m

etr

on

idazo

le

gro

up

an

d 7

.5%

of

pla

ceb

o g

rou

p;

for

spo

nta

neo

us

pre

term

bir

th, v

alu

es w

ere 4

.7%

an

d 5

.6%

; fo

r P

RO

M,

valu

es w

ere

2.8

% a

nd

3.3

%

-In

su

bse

t o

f 4

80

wo

men

wit

h B

V o

nly

– n

o d

iffe

r-en

ce i

n p

rete

rm b

irth

rate

, sp

on

tan

eou

s p

rete

rm b

irth

rate

or

PR

OM

rat

e -I

n s

ub

set

of

46

wo

men

wit

h p

rev

iou

s p

rete

rm b

irth

, m

etro

nid

azo

le g

rou

p h

ad l

ow

er r

ate

of

spo

nta

neo

us

pre

term

bir

th (

OR

=0

.14

, 9

5%

CI:

0.0

1-0

.84

) -N

o d

iffe

ren

ces

in n

um

ber

s o

f in

fan

ts r

equ

irin

g I

CU

ad

mis

sio

n o

r d

ura

tio

n o

f n

urs

ery

sta

y

-No

dif

fere

nce

in

rep

ort

ing

of

sid

e ef

fects

-Metr

on

idazo

le t

reat

men

t o

f w

om

en w

ith

a

hea

vy

gro

wth

of

G.

vag

ina

lis

or

BV

did

no

t re

du

ce t

he p

rete

rm b

irth

rate

. A

mo

ng

w

om

en w

ith

pre

vio

us

pre

term

bir

th,

trea

t-m

ent

red

uced

th

e ri

sk o

f sp

on

tan

eou

s p

re-

term

bir

th.

NO

TE

S:

att

emp

ted

to

do

scr

een

ing

at

18

w

ks,

en

roll

at

24

wk

s, t

est-

of-

cure

at

28

wk

s,

seco

nd

co

urs

e at

29

wk

s (i

f n

eed

ed),

an

d f

ol-

low

-up

at

32

-36

wk

s (u

nle

ss d

eliv

ery

alr

ead

y

occ

urr

ed);

did

sam

ple

siz

e e

stim

atio

n –

wit

h

exp

ecte

d 3

8%

hig

her

pre

term

bir

th r

ate

th

an

ov

eral

l p

op

ula

tio

n, 1

,32

8 w

om

en w

ere

nee

ded

; an

in

teri

m a

naly

sis

at 8

79

wo

men

in

dic

ated

th

at

the

dif

fere

nce

in

pre

term

bir

th

rate

was

low

er t

han

ex

pect

ed r

equ

irin

g a

sa

mp

le s

ize 1

0 t

imes

lar

ger

(n

ot

feasi

ble

);

wit

h 8

79

en

roll

ed,

26

% p

ow

er t

o d

ete

ct a

3

8%

red

ucti

on

sp

on

tan

eou

s p

rete

rm b

irth

ra

te;

analy

sis

was

by

in

ten

tio

n t

o t

reat

Wo

rk G

rou

p’s

Co

mm

ents

: t

he s

creen

ing

w

as

do

ne l

ate

r in

th

e p

reg

na

ncy

tha

n r

ec-

om

men

ded

an

d t

he

met

ron

ida

zole

do

se w

as

low

er t

ha

n t

he

reco

mm

end

ed d

ose

of

25

0 m

g

ora

lly,

3X

/da

y,

for

7 d

ays


www.icsi.org

43


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Car

ey,

et a

l.

(20

00

) R

CT

A

ø

-S

cree

ned

w

om

en b

etw

een

8

wk

s an

d 2

2 w

ks,

6 d

ays

of

ges

-ta

tio

n f

or

BV

an

d T

. va

gin

ali

s -E

xcl

ud

ed:

sy

mp

tom

s o

f B

V;

alle

rgy

to

met

ron

idaz

ole

; ab

use

o

f et

han

ol;

an

tib

ioti

c t

her

apy

in

p

ast

14

day

s; i

nte

nti

on

to

re-

ceiv

e fu

ture

car

e at

dif

fere

nt

lo-

cati

on

; cu

rren

t o

r p

lan

ned

cer

vi-

cal

cer

cla

ge

or

toco

lyti

c th

er-

apy

; p

rete

rm l

abo

r b

efo

re

scre

enin

g;

feta

l d

eat

h o

r li

fe-

thre

ate

nin

g a

no

mal

y;

mu

ltif

etal

g

esta

tio

n;

med

ical

ill

nes

s re

qu

ir-

ing

ex

ten

siv

e d

rug

th

erap

y

-Ran

do

miz

ed t

ho

se w

ith

BV

o

nly

an

d p

reg

nan

cies

bet

wee

n

16

wk

s an

d 2

3 w

ks,

6 d

ays

-Ran

do

miz

ed t

o 2

g m

etro

nid

a-zo

le o

r p

laceb

o (

2 d

ose

s 4

8 h

rs

apar

t);

foll

ow

-up

at

24

wk

s to

29

wk

s, 6

day

s w

ith

seco

nd

tr

eatm

ent

(2 d

ose

s) r

egar

dle

ss o

f te

st r

esu

lts

-21

,96

5 w

ere

scre

ened

; 6

,54

0 h

ad B

V o

nly

; 1

,95

3

wer

e ra

nd

om

ized

-C

om

pli

ance

mo

nit

ore

d a

fter

1st 3

do

ses

on

ly –

79

%

of

metr

on

idazo

le g

rou

p a

nd

82

% o

f p

laceb

o h

ad

tak

en t

he

full

do

se;

90

% r

etu

rned

fo

r fo

llo

w-u

p v

isit

-O

utc

om

e d

ata

av

aila

ble

fo

r 9

8%

: n

o d

iffe

ren

ce i

n

freq

uen

cy o

f d

eli

ver

y a

t <

37

wk

s g

esta

tio

n (

or

de-

liv

ery

bef

ore

35

or

32

wk

s);

no

dif

fere

nces

wit

h r

e-g

ard

to

lo

w b

irth

wei

gh

t, v

ery

lo

w b

irth

weig

ht,

or

pre

term

deli

ver

y a

ttri

bu

tab

le t

o s

po

nta

neo

us

lab

or

or

spo

nta

neo

us

rup

ture

of

the m

em

bra

nes

-Of

tho

se w

ith

fo

llo

w-u

p t

esti

ng

, 2

2%

in

metr

on

ida-

zole

gro

up

an

d 6

3%

in

pla

ceb

o g

rou

p s

till

had

BV

-N

o d

iffe

ren

ce i

n a

dm

issi

on

s to

ho

spit

al

for

pre

term

lab

or

or

pre

term

PR

OM

, re

ceip

t o

f to

coly

tic

dru

gs,

v

agin

al

infe

cti

on

s re

qu

irin

g t

reatm

ent,

cli

nic

al

in-

traa

mn

ioti

c in

fecti

on

or

po

stp

artu

m e

nd

om

etr

itis

-N

o d

iffe

ren

ce i

n p

assa

ge

of

meco

niu

m, fe

tal

dea

th

or

neo

nat

al d

eath

, ad

mis

sio

n t

o N

ICU

or

pre

sen

ce

of

neo

nat

al s

epsi

s

-Tre

atm

ent

of

asy

mp

tom

atic

BV

wit

h m

et-

ron

idaz

ole

did

no

t re

du

ce

the

risk

of

pre

term

d

eliv

ery

in

wo

men

at

low

ris

k f

or

pre

term

d

eliv

ery

or

wo

men

wit

h a

his

tory

of

pre

term

d

eliv

ery

. N

OT

ES

: s

ho

rt c

ou

rse o

f tr

eatm

ent

was

cho

-se

n t

o i

mp

rov

e co

mp

lian

ce

Wo

rk G

rou

p’s

Co

mm

ents

: t

he s

creen

ing

w

as

do

ne l

ate

r in

th

e p

reg

na

ncy

tha

n r

ec-

om

men

ded

an

d t

he

met

ron

ida

zole

do

se w

as

low

er t

ha

n t

he

reco

mm

end

ed d

ose

of

25

0 m

g

ora

lly,

3X

/da

y,

for

7 d

ays


www.icsi.org

44

Conclusion Grading Worksheet B – Annotation #66(Management of Protracted Labor)


Work

Grou

p's

Con

clu

sion

: A

ctiv

e m

anag

emen

t of

labo

r does

not

reduce

the

rate

of

Cae

sare

an d

eliv

ery b

ut

may

dec

reas

e th

e le

ngth

of

labor

and i

ncr

ease

pat

ient

sati

sfac

tion i

n n

ull

ipara

s.

Con

clu

sio

n G

rad

e:

II

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Nai

den

&

Des

hp

and

e

(20

01

)

Cas

e S

erie

s D

–

-D

eliv

ery

sta

tist

ics

for

10

-yr

pe-

rio

d a

s o

bta

ined

fro

m b

irth

lo

g-

bo

ok

; p

rio

r to

dat

a co

llect

ion

p

erio

d s

taff

ag

reed

wit

h g

oal

of

few

er o

per

ativ

e d

eli

ver

ies;

th

ose

w

ith

hig

her

rat

es r

evie

wed

lit

-er

atu

re;

eac

h p

rov

ider

giv

en

ow

n d

eliv

ery

sta

tist

ics

-Sta

ff a

lso

ag

reed

on

pro

toco

ls*

for

acti

ve m

anag

em

ent

of

lab

or

-VB

AC

was

en

cou

rag

ed

-Nu

rsin

g s

taff

mai

nta

ined

bir

th

log

bo

ok

(m

ater

nal

info

rmat

ion

an

d c

om

pli

cati

on

s, l

abo

r in

for-

mat

ion

, fe

tal

info

rmat

ion

); d

ata

also

co

llecte

d o

n C

aesa

rean

de-

liv

ery

rate

fo

r 5

yrs

pri

or

to

stu

dy

-N

eon

atal

mo

rbid

ity

: b

irth

tr

aum

a, p

rese

nce

of

thic

k m

eco

-n

ium

, lo

w A

PG

AR

sco

re (

<6

at

5 m

in),

per

inat

al d

eat

h

-27

,78

0 d

eliv

erie

s in

10

yrs

; 3

,18

6 w

ere C

aesa

rean

-R

isk

fact

ors

fo

r C

aesa

rean

st

able

th

rou

gh

ou

t st

ud

y

per

iod

(%

of

nu

llip

aro

us

bir

ths,

ag

e <

19

yrs

, ag

e >

35

yrs

, m

ult

iple

ges

tati

on

s, b

irth

wei

gh

t <

2,5

00

g,

bir

th w

eig

ht

>4

,00

0 g

, g

esta

tio

nal

age

<3

7 w

ks,

ges

-ta

tio

nal

age >

41

wk

s)

-% M

edic

aid

deli

ver

ies

rem

ain

ed a

t ap

pro

xim

ate

ly

66

%;

% o

f H

isp

anic

-su

rnam

e p

ati

ents

in

creas

ed

fro

m 3

5%

in

19

89

to

50

% i

n 1

99

8

-Caes

area

n d

eliv

ery

rat

es:

19

89

19

98

T

ota

l 1

6.6

%

10

.9%

P

rim

ary

9

.2%

7

.1%

R

epea

t d

eli

ver

ies

7.4

%

3.8

%

Nu

llip

aro

us

16

.4%

1

1.9

%

Mu

ltip

aro

us

16

.8%

1

0.5

%

-Sig

nif

ican

t d

ecr

eas

e i

n r

ate

of

Cae

sare

an d

eliv

ery

for

cep

halo

pel

vic

dis

pro

po

rtio

ns

(p<

0.0

01

); d

e-cr

ease

s fo

r o

ther

in

dic

ati

on

s w

ere

no

t si

gn

ific

ant

-Sig

nif

ican

t in

creas

es (

p<

0.0

01

): o

xy

tocin

use

, in

-st

rum

ente

d v

agin

al d

eliv

ery

, an

d e

pid

ura

l an

esth

esia

-N

o s

ign

ific

ant

chan

ges

in n

eon

ata

l m

orb

idit

y r

ate,

p

erin

ata

l an

d n

eon

ata

l m

ort

ali

ty r

ates

, o

r n

um

ber

of

stil

lbir

ths

-In

10

-yea

r st

ud

y p

erio

d,

Cae

sare

an d

eli

ver

y

rate

s w

ere

low

ered

sig

nif

ican

tly

wh

ile n

ot

adv

erse

ly i

ncr

eas

ing

in

dic

ato

rs o

f p

erin

atal

m

orb

idit

y o

r d

eat

h.

Mo

st o

f th

e r

edu

cti

on

w

as d

ue t

o i

ncr

easi

ng

th

e a

cti

ve

man

age-

men

t o

f la

bo

r an

d t

o e

nco

ura

gin

g V

BA

C d

e-li

ver

ies.

NO

TE

S:

*p

roto

col

cal

led

fo

r o

xy

tocin

in

fu-

sio

n o

nly

un

der

su

per

vis

ion

of

atte

nd

ing

p

hy

sici

an;

on

ly a

llo

wed

nu

rses

wit

h e

xp

eri-

ence

in

lab

or

and

deli

ver

y a

nd

ass

essm

ent

of

feta

l h

eart

rate

patt

ern

s an

d i

nit

ial

man

age-

men

t o

f ab

no

rmal

pat

tern

s to

pra

cti

ce

the

pro

toco

l


www.icsi.org

45

Conclusion Grading Worksheet B – Annotation #66 Management of Labor (Management of Protracted Labor) Third Edition/May 2009

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Sad

ler,

Dav

i-so

n, &

M

cCo

wan

(2

00

0)

RC

T

A

ø

-In

clu

ded

: n

ull

ipar

ou

s; s

ing

le-

ton

pre

gn

ancy

, n

o s

ever

e c

ar-

dia

c d

isea

se, n

o u

teri

ne

scar

, n

o

pro

ven

co

ntr

act

ed p

elv

is

-Ex

clu

ded

: i

nd

uced

lab

or;

no

n-

cep

hali

c p

rese

nta

tio

n;

ges

tati

on

<

37

wk

s, a

bn

orm

al

card

ioto

cog

-

rap

hy

or

thic

k m

eco

niu

m,

ele

c-ti

ve C

aes

area

n;

intr

aute

rin

e d

eath

, m

ult

ipar

ity

-R

and

om

ized

to

act

ive o

r ro

u-

tin

e m

gm

t o

f la

bo

r -A

ctiv

e m

gm

t g

rou

p e

nco

ura

ged

to

hav

e a

mn

ioto

my

at

dia

gn

osi

s

of

lab

or;

cer

vic

al

ass

ess

men

t ev

ery

2 h

rs;

ox

yto

cin

if

pro

gre

ss

del

ayed

; n

o p

roto

col

for

rou

tin

e m

gm

t -D

id m

eta-

analy

sis

of

4 s

tud

ies

of

acti

ve

vs.

ro

uti

ne

mg

mt

(in

-cl

ud

ing

pre

sen

t st

ud

y)

-32

0 r

and

om

ized

to

act

ive m

gm

t an

d 3

31

to

ro

uti

ne;

no

dif

fere

nces

at

base

lin

e; m

ore

wo

men

in

th

e a

ctiv

e

mg

mt

gro

up

had

am

nio

tom

y (

72

% v

s. 6

3%

; p

<0

.05

) an

d a

t lo

wer

dil

atat

ion

(5

.1 c

m v

s. 5

.7 c

m;

p=

0.0

06

);

ox

yto

cin

use

d m

ore

co

mm

on

ly (

53

% v

s. 3

9%

; p

<0

.05

) an

d a

t h

igh

er d

ose

s (p

=0

.00

01

) in

acti

ve

mg

mt

gro

up

; n

o d

iffe

ren

ce

in e

pid

ura

l ra

tes

or

nu

m-

ber

rec

eiv

ing

on

e-to

-on

e m

idw

ifer

y

-Lab

or

red

uced

by

50

min

in

acti

ve

mg

mt

gro

up

(fo

r v

agin

al

deli

ver

ies)

; re

du

cti

on

in

fir

st s

tag

e o

f la

bo

r o

nly

; 5

% o

f ac

tiv

e m

gm

t g

rou

p h

ad p

rolo

ng

ed l

abo

r (v

s. 1

2%

of

rou

tin

e m

gm

t; p

<0

.05

) -C

aes

area

n d

eliv

ery

rat

es d

id n

ot

dif

fer

(9%

acti

ve

mg

mt,

10

% r

ou

tin

e m

gm

t);

adju

stm

ent

for

age,

eth

-

nic

ity

, g

esta

tio

nal

ag

e, b

irth

wei

gh

t, e

pid

ura

l u

se,

and

dil

ata

tio

n a

t ra

nd

om

izat

ion

did

no

t al

ter

od

ds

of

Caes

area

n d

eliv

ery

(u

nad

just

ed &

ad

just

ed

OR

s=0

.97

) -N

ewb

orn

ou

tco

mes

did

no

t d

iffe

r -M

ate

rnal

sati

sfact

ion

wit

h l

abo

r ca

re d

id n

ot

dif

fer

-40

% o

f act

ive m

gm

t p

atie

nts

did

no

t ad

her

e to

!1

asp

ect

of

pro

toco

l -M

eta

-an

aly

sis

sho

wed

no

red

ucti

on

in

Cae

sare

an

rate

wit

h a

cti

ve

mg

mt

(OR

=0

.93

; 9

5%

CI:

0.8

-1.0

8)

-Act

ive

man

agem

ent

of

lab

or

red

uced

th

e d

ura

tio

n o

f th

e f

irst

sta

ge

of

lab

or

wit

ho

ut

affe

cti

ng

th

e r

ate

of

Caes

area

n s

ect

ion

, m

a-te

rnal

sati

sfac

tio

n,

or

oth

er m

ater

nal

or

new

-b

orn

mo

rbid

ity

. N

OT

ES

: l

abo

r w

as d

efin

ed a

s co

ntr

act

ion

s o

ccu

rrin

g a

t le

ast

on

ce

ever

y 5

min

s; l

asti

ng

!

40

sec

, w

ith

sp

on

tan

eou

s ru

ptu

re o

f m

em-

bra

nes

or

full

eff

ace

men

t o

f ce

rvix

an

d d

ila-

tati

on

of !

2 c

m;

did

sam

ple

siz

e e

stim

ati

on

–

32

0 p

er a

rm o

f st

ud

y t

o d

etec

t re

du

ctio

n i

n

Caes

area

n r

ate

fro

m 1

8%

to

10

% w

ith

po

wer

=8

0%

; alp

ha=

0.0

5


www.icsi.org

46


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Fra

ser,

Tu

rco

t,

Kra

uss

, B

ris-

son

-Car

rol

(20

00

)

Sy

s-te

mati

c R

evie

w

M

N/A

-I

ncl

ud

ed:

9 r

and

om

ized

tri

als

com

par

ing

ro

uti

ne

am

nio

tom

y

to a

n a

ttem

pt

to c

on

serv

e th

e

mem

bra

nes

; ca

teg

ori

cal

data

av

aila

ble

on

maj

or

ind

icato

rs o

f m

ater

nal

& n

eon

ata

l m

orb

idit

y;

accep

tab

le m

eth

od

olo

gic

al q

ual

-

ity

, n

o e

vid

ence

of

syst

emat

ic

erro

r in

ran

do

miz

ati

on

or

fol-

low

-up

pro

cess

es;

wo

men

in

sp

on

tan

eou

s la

bo

r

-5 t

rial

s w

ere

nu

llip

aro

us

wo

men

on

ly;

4 w

ere m

ix

of

nu

llip

aro

us

and

mu

ltip

aro

us

-Use

of

ox

yto

cin

var

ied

in

stu

die

s (h

ete

rog

eneit

y)

-Ear

ly u

se o

f am

nio

tom

y l

ead

s to

an

av

erag

e re

duc-

tio

n o

f la

bo

r d

ura

tio

n o

f 6

0-1

20

min

ute

s; l

eng

th o

f la

bo

r (f

rom

ran

do

miz

ati

on

to

deli

ver

y)

was

sig

nif

i-ca

ntl

y r

edu

ced

by

54

min

ute

s in

ear

ly a

mn

ioto

my

gro

up

(N

OT

E:

data

fro

m 3

stu

die

s)

-In

cid

ence

of

dy

sto

cia

was

red

uced

in

th

e am

nio

t-o

my

gro

up

(O

R=

0.6

3)

(NO

TE

: d

ata

fro

m 1

stu

dy

) -T

ren

d t

ow

ard

in

creas

ed r

isk

of

Cae

sare

an w

ith

ea

rly

am

nio

tom

y

-Am

nio

tom

y i

s an

eff

ect

ive m

eth

od

to

sh

ort

en l

abo

r d

ura

tio

n a

nd

red

uce

the f

re-

qu

ency

of

ox

yto

cin

ad

min

istr

atio

n.

Th

ere

was

no

ev

iden

ce o

f ad

ver

se n

eon

ata

l co

nse

-q

uen

ces.

It

wo

uld

see

m r

eas

on

able

to

re-

serv

e am

nio

tom

y f

or

lab

ors

th

at a

re p

ro-

gre

ssin

g s

low

ly.

NO

TE

S:

stu

die

s w

ere

do

ne i

n c

ente

rs w

her

e

a la

rge p

rop

ort

ion

of

mo

ther

s re

ceiv

ed

epid

ura

l an

esth

esia

; co

mp

lian

ce w

ith

th

e co

nse

rvati

ve

app

roach

was

lo

w

Ro

use

, O

wen

, &

Hau

th (

19

99

) C

ase

Ser

ies

D

ø

-Wo

men

!3

6 w

ks

ges

tati

on

wit

h

1)

spo

nta

neo

us

acti

ve

ph

ase l

a-b

or

(dil

ata

tio

n !

4 c

m,

at l

east

2

con

tract

ion

s in

10

min

ute

s) &

2)

lab

or

arre

st ("

1 c

m c

erv

ical

pro

gre

ss i

n 2

hrs

) -E

xcl

ud

ed:

no

nv

erte

x p

rese

nta

-

tio

n;

pre

vio

us

Cae

sare

an d

eliv

-er

y;

mu

ltip

le g

esta

tio

n;

no

n-

reas

suri

ng

FH

R t

raci

ng

, ch

ori

oam

nio

nit

is, o

r sp

on

tan

e-o

us

con

tract

ion

s !

25

0 M

on

tev

i-d

eo u

nit

s at

tim

e o

f la

bo

r ar

rest

-O

xy

toci

n a

dm

inis

tere

d a

t d

iag

-

no

sis

of

acti

ve-

ph

ase l

abo

r ar

-re

st;

Caes

area

n d

eli

ver

y f

or

la-

bo

r ar

rest

do

ne

afte

r 4

hrs

of

ox

yto

cin

wit

h s

ust

ain

ed c

on

trac-

tio

n p

atte

rn >

20

0 M

on

tev

ideo

u

nit

s o

r 6

hrs

ox

yto

cin

reg

ard

-le

ss o

f co

ntr

act

ion

patt

ern

-54

2 e

lig

ible

: 2

88

(5

3%

) n

ull

ipar

ou

s, 2

54

(4

7%

) p

aro

us;

gro

up

s w

ere

sim

ilar

dem

og

rap

hic

all

y

-Vag

inal

deli

ver

y r

ate

92

% o

ver

all

(9

7%

fo

r p

aro

us

gro

up

, 8

8%

fo

r n

ull

ipar

ou

s)

-Vag

inal

deli

ver

y r

ate

s am

on

g t

ho

se w

ith

no

pro

-g

ress

aft

er 2

hrs

of

ox

yto

cin

: 9

1%

fo

r p

aro

us

gro

up

, 7

4%

fo

r n

ull

ipar

ou

s g

rou

p

-Vag

inal

deli

ver

y r

ate

s am

on

g t

ho

se w

ith

no

pro

-g

ress

aft

er 4

hrs

of

ox

yto

cin

: 8

8%

fo

r p

aro

us

gro

up

, 5

6%

fo

r n

ull

ipar

ou

s g

rou

p

-No

ute

rin

e ru

ptu

re o

r h

yst

erect

om

y;

rate

s o

f ch

ori

oam

nio

nit

is (

10

%)

and

en

do

met

riti

s (5

%)

wer

e

hig

her

fo

r n

ull

ipar

as t

han

par

ou

s w

om

en (

bo

th 2

%);

la

bo

r p

rog

ress

(o

r la

ck t

her

eof)

co

rrela

ted

wit

h r

isk

of

mate

rnal

infe

ctio

us

com

pli

cat

ion

s -N

o s

till

bir

ths

or

neo

nat

al d

eath

s; c

om

pli

cat

ion

s d

id

no

t d

iffe

r b

ased

on

wh

eth

er t

her

e w

as l

abo

r p

ro-

gre

ss, n

o p

rog

ress

, o

r n

o e

xam

inat

ion

-4

2 C

aes

area

n d

eliv

erie

s (2

4 l

abo

r ar

rest

, 1

0

no

n-r

eass

uri

ng

feta

l st

atu

s, 8

bo

th l

abo

r ar

rest

an

d

no

n-r

eass

uri

ng

sta

tus)

-Th

e m

anag

emen

t p

roto

col

use

d i

n t

his

stu

dy

re

sult

ed i

n a

hig

h r

ate

of

vag

inal

del

iver

y

(92

%)

wit

h n

o s

ever

e a

dv

erse

mate

rnal

, fe

tal

or

neo

nat

al o

utc

om

es.

Ex

ten

din

g t

he m

ini-

mu

m p

erio

d o

f o

xy

tocin

au

gm

enta

tio

n f

or

acti

ve-

ph

ase

lab

or

fro

m 2

to

at

leas

t 4

ho

urs

w

as e

ffec

tiv

e an

d s

afe.

NO

TE

S:

ox

yto

cin

do

se w

as o

ne

m#

/min

in

-cr

ease

d e

ver

y 1

5 m

in o

ver

2 h

rs t

o

30

m#

/min

; 9

3%

rec

eiv

ed c

on

tin

uo

us

lum

bar

ep

idu

ral

anal

ges

ia


www.icsi.org

47


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Lav

end

er,

Alf

irev

ic,

&

Wal

kin

shaw

(1

99

8)

Lav

end

er, W

al-

lym

ahm

ed,

&

Wal

kin

shaw

(1

99

9)

RC

T

A

ø

-Pri

mig

rav

idas

wit

h u

nco

mp

li-

cate

d p

reg

nan

cie

s; s

po

nta

neo

us

lab

or

at t

erm

; si

ng

leto

n c

eph

ali

c p

rese

nta

tio

n

-Ran

do

miz

ed t

o h

ave p

rog

ress

o

f la

bo

r re

cord

ed o

n a

par

-to

gra

m w

ith

an

act

ion

lin

e a

t 2

,

3 o

r 4

hrs

; p

rolo

ng

ed l

abo

r d

e-fi

ned

as

pro

gre

ss r

eac

hin

g a

c-ti

on

lin

e; o

bst

etri

c i

nte

rven

tio

n

(am

nio

tom

y a

nd

ox

yto

cin

if

mem

bra

nes

in

tact;

ox

yto

cin

o

nly

if

mem

bra

nes

ru

ptu

red

) tr

igg

ered

by

act

ion

lin

e

-Qu

esti

on

nai

re g

iven

on

sec

on

d

po

stn

atal

day

to

61

8 p

ati

ents

ra

nd

om

ized

in

fir

st y

ear

of

stu

dy

-Fro

m 1

99

8 r

eferen

ce:

-92

8 w

om

en r

and

om

ized

-C

aes

area

n d

eliv

ery

rat

es:

11

.1%

fo

r 2-h

r g

rou

p,

14

.2%

fo

r 3

-hr

gro

up

, &

8.4

% f

or

4-h

r g

rou

p;

sig

-n

ific

ant

dif

fere

nce

(p<

0.0

5)

bet

wee

n 3

an

d 4

hrs

-W

om

en i

n 2

ho

ur

gro

up

mo

re s

ati

sfie

d w

ith

th

eir

la

bo

r th

an (

p<

0.0

00

01

vs.

3 a

nd

4 h

ou

rs)

-Fro

m 1

99

9 r

eferen

ce:

-Dat

a fr

om

51

9 w

ho

ret

urn

ed q

ues

tio

nn

air

e (8

6.5

%

resp

on

se);

res

po

nse

rate

s si

mil

ar i

n t

he

3 g

rou

ps

-No

dif

fere

nce

s in

in

trap

artu

m o

utc

om

es e

xcep

t ac

-ti

on

lin

e cr

oss

ed f

or

50

% o

f 2

-hr

gro

up

an

d 3

7%

of

4-h

r g

rou

p (

p=

0.0

2)

and

in

terv

enti

on

occu

rred

in

4

6%

of

2-h

r g

rou

p a

nd

33

% o

f 4

-hr

gro

up

(p

=0

.02

);

Caes

area

n d

eliv

ery

rat

e d

id n

ot

dif

fer

in t

his

sub

-g

rou

p

-Wo

men

pre

fer

acti

ve m

anag

em

ent

of

lab

or.

E

arli

er i

nte

rven

tio

n m

ay b

e as

soci

ated

wit

h

hig

her

Caes

area

n d

eliv

ery

rat

es.

NO

TE

S:

qu

esti

on

nair

es w

ere

com

ple

ted

an

d

retu

rned

at

the

pati

ent’

s co

nv

enie

nce

Wo

rk G

rou

p’s

Co

mm

ents

: ra

nd

om

iza

tio

n

wa

s d

on

e b

y ca

re p

rovid

ers

in t

he

lab

or

an

d

del

ivery

un

it;

a c

om

men

tary

by

Ha

nn

ah

(B

irth

19

99

;26

:97

-98

) n

ote

d n

on

-sig

nif

ica

nt

dif

fere

nces

bet

ween

gro

up

s in

% w

ith

dil

ata

-

tio

n <

3 c

m a

t ra

nd

om

iza

tio

n a

nd

ep

idu

ral

an

alg

esic

use


www.icsi.org

48


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Fri

go

lett

o,

Lie

-b

erm

an,

Lan

g,

et a

l. (

19

95

)

RC

T

A

ø

-3,0

28

nu

llip

aro

us

wo

men

eli

gi-

ble

; 1

93

4 (

64

%)

agre

ed t

o p

ar-

tici

pat

e an

d w

ere

ran

do

miz

ed t

o

acti

ve m

gm

t (n

=1

01

7)

or

usu

al

care

(n

=9

17

); d

ata

mis

sin

g f

rom

1

9

-Ran

do

miz

atio

n b

efo

re 3

0 w

ks

ges

tati

on

; el

igib

le p

ati

ents

had

n

o c

on

dit

ion

s as

socia

ted

wit

h

incr

eas

ed r

isk

of

pre

term

or

Caes

area

n d

eliv

ery

-B

oth

gro

up

s: fe

tal

hea

rt r

ate

mo

nit

ori

ng

; ac

cess

to

pain

reli

ef

-Act

ive

mg

mt

gro

up

: c

ared

fo

r

in a

sep

arate

un

it b

y d

iffe

ren

t st

aff;

in

clu

ded

1-t

o-1

nu

rsin

g

care

, st

and

ard

ized

dia

gn

osi

s o

f la

bo

r, a

nd

mg

mt

of

lab

or

(am

ni-

oto

my

wit

hin

1 h

r o

f d

iag

no

sis,

ce

rvic

al

exam

s at

lea

st e

ver

y 2

h

rs, o

xy

tocin

du

rin

g e

ith

er s

tag

e

1 o

r st

age

2 o

f la

bo

r);

in f

inal

p

roto

col

fail

ure

to

pro

gre

ss w

as

fail

ure

of

no

rmal

pro

gre

ss o

f ce

rvic

al

dil

atat

ion

or

seco

nd

st

age

of

>2

hrs

(>

3 h

rs i

f ep

idu

ral

cat

het

er)

-Usu

al C

are G

rou

p:

no

co

n-

stra

ints

on

ph

ysi

cian

s

-In

ten

tio

n-t

o-t

reat

(IT

T)

anal

ysi

s:

all

ran

do

miz

ed

-Pro

toco

l-eli

gib

le s

ub

gro

up

an

aly

sis:

th

ose

med

ical-

ly e

lig

ible

to

rece

ive t

reatm

ent

acco

rdin

g t

o p

roto

col

at t

ime

of

on

set

of

lab

or

-IT

T a

nal

ysi

s:

data

fro

m 1

91

5 p

ati

ents

; C

aes

arean

ra

te w

as

19

.5%

in

act

ive m

gm

t g

rou

p a

nd

19

.4%

in

u

sual

car

e g

rou

p;

resu

lts

un

chan

ged

wh

en a

dju

sted

for

bas

eli

ne

char

act

eris

tics

or

epid

ura

l an

est

hes

ia

use

; C

aesa

rean

rate

s d

ue t

o f

ailu

re t

o p

rog

ress

wer

e 7

% i

n a

ctiv

e m

gm

t an

d 8

% i

n u

sual

car

e g

rou

ps

-Su

bg

rou

p a

nal

ysi

s:

a. 3

3%

of

the a

ctiv

e m

gm

t g

rou

p a

nd

35

% o

f th

e u

sual

car

e g

rou

p d

evelo

ped

med

ical

co

mp

lica

tio

ns

or

had

lab

or

ind

uced

an

d w

ere i

nel

igib

le;

the p

roto

-

col-

eli

gib

le s

ub

gro

up

in

clu

ded

67

8 i

n a

cti

ve

mg

mt

and

58

5 i

n u

sual

car

e;

63

3 i

n a

ctiv

e m

gm

t g

rou

p

wer

e tr

eat

ed a

cco

rdin

g t

o p

roto

col

b. G

rou

ps

did

no

t d

iffe

r at

bas

elin

e c.

Act

ive m

gm

t g

rou

p h

ad m

ore

fre

qu

ent

vag

inal

ex

-am

s, h

ad m

em

bra

nes

rup

ture

d a

rtif

icia

lly

mo

re o

ften

(a

nd

ear

lier

), w

ere m

ore

lik

ely

to

rece

ive o

xy

tocin

,

had

hig

her

max

imal

do

se o

f o

xy

toci

n, re

qu

este

d

epid

ura

l an

esth

esia

les

s o

ften

(p

<0

.05

) d

. O

ver

all

rate

s o

f C

aes

arean

deli

ver

y w

ere

sim

ilar

: 1

0.9

% i

n a

ctiv

e m

gm

t g

rou

p a

nd

11

.5%

in

usu

al

care

gro

up

(R

R=

0.9

); f

or

bo

th g

rou

ps,

rate

of

Cae

-sa

rean

beca

use

of

feta

l d

istr

ess

was

lo

w (

2.2

% i

n a

c-ti

ve m

gm

t g

rou

p a

nd

1.2

% i

n u

sual

care

gro

up

);

sho

rter

lab

or

in a

ctiv

e m

gm

t g

rou

p (

6.2

hrs

vs.

8.9

h

rs)

e. L

ow

er i

ncid

ence

of

mat

ern

al f

ever

in

act

ive

mg

mt

gro

up

(R

R=

0.6

); o

ther

co

mp

lica

tio

ns

wer

e sa

me

for

bo

th g

rou

ps;

no

dif

fere

nces

in

in

fan

ts' o

utc

om

es

-Th

e sa

fety

of

an a

ctiv

e m

anag

em

ent

pro

to-

col

was

co

nfi

rmed

. N

o s

ub

stan

tial

decr

eas

e

in t

he

rate

of

Caes

area

n d

eli

ver

y w

as o

b-

serv

ed.

NO

TE

S:

in

clu

ded

all

co

mp

on

ents

of

pro

to-

col

for

acti

ve

mg

mt

of

lab

or;

im

ple

men

ted

ac

tiv

e m

gm

t w

ith

sep

arate

sta

ff i

n a

ph

ysi

-ca

lly

sep

arat

e d

eliv

ery

un

it;

Haw

tho

rne

ef-

fect

may

hav

e ac

cou

nte

d f

or

resu

lts

(stu

dy

fo

cuse

d o

n r

ate

s o

f C

aesa

rean

deli

ver

y s

o

rate

in

usu

al

care

gro

up

may

hav

e b

een

low

-er

ed)


www.icsi.org

49


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Ló

pez

-Zen

o,

Pea

cem

an,

Ad

ash

ek,

&

So

col

(19

92

)

RC

T

A

ø

-70

5 n

ull

ipar

ou

s w

om

en i

n

spo

nta

neo

us

lab

or

at !

37

wk

s,

excl

ud

ed m

ult

iple

gest

atio

n,

no

nce

ph

alic

pre

sen

tati

on

an

d

pre

vio

us

ute

rin

e su

rger

y

-Ran

do

mly

ass

ign

ed t

o e

ith

er

acti

ve o

r tr

adit

ion

al m

anag

e-

men

t

-Bo

th g

rou

ps:

fe

tal

hea

rt r

ate

mo

nit

ore

d, fr

eq. an

d i

nte

nsi

ty o

f co

ntr

act

ion

s as

sess

ed b

y t

o-

ko

dy

nam

om

etry

; u

mb

ilic

al-c

ord

ar

teri

al

and

ven

ou

s b

loo

d o

b-

tain

ed a

t d

eli

ver

y

-Act

ive

mg

mt

gro

up

: a

mn

iot-

om

y w

ith

in 1

hr

of

dia

gn

osi

s o

f la

bo

r (i

f m

emb

ran

es i

nta

ct)

; cer

-v

ical

exam

s ev

ery

hr

for

the f

irst

3

hrs

an

d t

hen

ev

ery

2 h

rs;

ox

y-

toci

n i

f ra

te o

f d

ilati

on

was

<1

cm

/hr

in 1

st s

tag

e o

f la

bo

r o

r if

des

cen

t o

f h

ead

was

arr

est

ed f

or

1 h

r in

2n

d s

tag

e -T

rad

. m

gm

t g

rou

p:

am

nio

t-o

my

, fr

eq.

of

cer

vic

al

exam

s,

and

cri

teri

a fo

r in

adeq

uate

pro

-g

ress

wer

e le

ft t

o t

he

ph

ysi

cia

n;

ox

yto

cin

was

use

d f

or

arre

st o

f

pro

gre

ss

-35

1 i

n a

ctiv

e m

gm

t an

d 3

54

in

tra

dit

ion

al

mg

mt

(co

ntr

ol

gro

up

); n

o d

iffe

ren

ces

in b

asel

ine c

har

acte

r-is

tics;

on

ly d

iffe

ren

ce

in c

har

act

eris

tics

of

lab

or

was

m

axim

al

do

se o

f o

xy

tocin

(h

igh

er i

n a

ctiv

e m

gm

t g

rou

p, p

<0

.00

01

) -O

utc

om

es:

A

ctiv

e M

gm

t

T

rad

itio

nal

Mg

mt

Caes

area

n D

eli

ver

y

3

7 (

11

%)

5

0 (

14

%)*

V

agin

al

Del

iver

y

31

4 (

90

%)

3

04

(8

6%

) *

Dif

fere

nce

was

sig

nif

ican

t (p

<0

.05

) af

ter

adju

st-

men

t fo

r p

ote

nti

al c

on

fou

nd

ing

var

iab

les

-Dif

fere

nce

in C

aes

arean

deli

ver

y r

ate

was

du

e p

ri-

mar

ily

to

a d

ecr

eas

e i

n t

he f

req

uen

cy o

f ar

rest

dis

or-

der

s

-Dif

fere

nce

was

gre

ate

r fo

r p

ati

ents

of

pri

vate

ph

ysi

-ci

ans

than

fo

r cl

inic

pati

ents

(1

1%

vs.

16

%)

-On

ly 4

.6%

of

pati

ents

in

act

ive m

gm

t g

rou

p h

ad n

ot

del

iver

ed b

y 1

2 h

ou

rs a

fter

ad

mis

sio

n c

om

par

ed t

o

18

.9%

in

th

e tr

adit

ion

al m

gm

t g

rou

p (

p<

0.0

01

) -N

o i

ncr

eas

e in

co

mp

licat

ion

s o

f la

bo

r in

acti

ve

mg

mt

gro

up

; act

ive m

anag

em

ent

had

gre

ate

r p

ercen

t

of

pat

ien

ts w

ith

ox

yto

cin

decr

ease

d o

r st

op

ped

(p

<0

.05

) an

d l

ow

er p

erce

nt

of

pat

ien

ts w

ith

ch

ori

oam

nio

nit

is (

p<

0.0

1)

-No

dif

fere

nce

s in

neo

nata

l o

utc

om

es

base

d o

n a

rte-

rial

pH

an

d o

ther

blo

od

gas

ind

exes

, b

irth

wei

gh

t,

AP

GA

R s

core

, N

ICU

ad

mis

sio

ns,

seiz

ure

s, d

ays

in

ho

spit

al;

no

in

creas

ed m

orb

idit

y i

n a

cti

ve

mg

mt

case

s

-Act

ive

man

agem

ent

of

lab

or

in n

ull

ipar

ou

s p

atie

nts

was

ass

ocia

ted

wit

h a

sig

nif

ican

t d

ecre

ase i

n r

ate

of

Cae

sare

an d

eli

ver

y w

ith

n

o d

etecta

ble

in

crea

se i

n m

ater

nal

or

feta

l m

orb

idit

y.

NO

TE

S:

stu

dy

on

ly t

este

d 3

co

mp

on

ents

of

acti

ve m

gm

t (e

arly

am

nio

tom

y,

ear

ly d

iag

-n

osi

s o

f in

adeq

uat

e p

rog

ress

, an

d u

se o

f o

xy

-to

cin

at

hig

her

do

ses

than

usu

al);

stu

dy

was

u

nb

len

ded

, w

hic

h m

ay h

ave c

on

trib

ute

d t

o

low

er C

aesa

rean

rate

in

tra

dit

ion

al

mg

mt

gro

up

; st

ud

y d

iffe

rs f

rom

oth

er s

tud

ies

of

ac-

tiv

e m

anag

em

ent

in t

hat

pre

nata

l p

atie

nt

edu

cati

on

was

no

t in

clu

ded

, n

urs

e-m

idw

ives

wer

e n

ot

use

d t

o m

anag

e l

abo

r, a

nd

use

of

con

du

ctio

n a

nest

hesi

a w

as c

om

mo

n

Wo

rk G

rou

p’s

Co

mm

ents

: d

id s

am

ple

siz

e

esti

ma

tio

n t

o d

ete

rmin

e t

ha

t 7

00

pa

tien

ts

wo

uld

nee

d t

o b

e s

tud

ied

to

ach

ieve

a p

ow

er

of

80

% f

or

dete

cti

ng

a d

ecr

ease

in

th

e r

ate

o

f C

aes

are

an

deli

very

fro

m 1

8%

(ex

pect

ed

wit

h t

rad

itio

na

l m

an

ag

emen

t) t

o 1

1%

(w

ith

a

ctiv

e m

an

ag

emen

t)


www.icsi.org

50


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Bo

yla

n,

Fra

nk

ow

ski,

R

ou

ntr

ee,

Sel-

wy

n, &

Par

rish

(1

99

1)

No

n-

Ran

-d

om

/ H

is-

tori

cal

C

on

-tr

ols

C

ø

-3,9

00

bir

ths

to n

ull

ipar

ou

s w

om

en;

bef

ore

an

d a

fter

in

tro

- d

uct

ion

of

AM

L p

rog

ram

(tw

o

6-m

on

th p

erio

ds

in e

ach

ph

ase

) -E

lig

ible

pat

ien

ts h

ad v

erte

x

pre

sen

tati

on

, si

ng

leto

n p

reg

-n

ancy

, an

d n

o e

vid

ence

of

feta

l

dis

tres

s -D

efin

itiv

e d

iag

no

sis

of

lab

or

wit

hin

1 h

r o

f p

rese

nta

tio

n

-Att

end

ing

MD

s co

uld

ex

clu

de

pat

ien

ts f

rom

AM

L b

ut

all

pa-

tien

ts w

ere

incl

ud

ed i

n a

nal

ysi

s

-If

mem

bra

nes

had

no

t ru

ptu

red

wit

hin

2 h

rs o

f d

iag

no

sis,

art

ifi-

cial

ru

ptu

re w

as d

on

e -O

xy

toci

n w

as g

iven

if

cerv

ix

fail

ed t

o d

ilat

e at

>1

cm

/hr

-Ele

ctro

nic

fet

al h

ear

t ra

te

mo

nit

ori

ng

in

all

case

s -I

f n

o d

eliv

ery

im

min

ent

wit

hin

12

hrs

of

adm

issi

on

co

nsi

der

ed

do

ing

CS

; ep

idu

ral

anes

thes

ia

free

ly a

vail

able

-D

uri

ng

co

ntr

ol

per

iod

, m

anag

e-m

ent

was

wit

h e

xis

tin

g m

eth

od

s

-Def

ined

CS

as

du

e t

o d

yst

ocia

wh

en i

nd

icati

on

was

fa

ilu

re t

o p

rog

ress

or

cep

hal

op

elv

ic d

isp

rop

ort

ion

; al

so d

efin

ed C

S f

or

feta

l d

istr

ess,

bre

ech

pre

sen

ta-

tio

n a

nd

"o

ther

" -O

utc

om

es:

Co

ntr

ol

Per

iod

A

ML

Per

iod

(

1,8

43

bir

ths)

(2

,05

7 b

irth

s)

1

2

To

t.

1

2

To

t.

% C

aes

area

n

23

24

2

4

20

18

1

9

% D

yst

ocia

57

58

48

46

%

Fo

rcep

s

3

6

30

% S

po

nt.

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inal

4

0

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1

NO

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: 1

an

d 2

ref

er t

o 1

st 6

mo

s an

d 2

nd

6 m

os

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% d

rop

du

rin

g A

ML

per

iod

in

in

cid

ence

(p<

0.0

5)

of

CS

; 1

0%

red

uct

ion

in

in

cid

ence

of

dy

sto

cia

as a

n i

nd

icat

ion

fo

r C

S (

p<

0.0

5)

-33

% o

f th

ose

wit

h C

S f

or

dy

sto

cia

wer

e d

ue

to n

on-

com

pli

ance

wit

h A

ML

pro

toco

l; 3

2%

wer

e a

sso

ci-

ated

wit

h i

nd

uct

ion

of

lab

or

-No

dif

fere

nce

s b

etw

een

co

ntr

ol

and

AM

L p

erio

ds

for

ges

tati

on

an

d b

irth

weig

ht

-Co

ntr

ol:

1

in

trap

artu

m d

eath

, 1

neo

nata

l d

eath

, 3

6

adm

itte

d t

o N

ICU

, 8

neo

nata

l se

izu

re (

4.3

per

10

00

) -A

ML

: n

o i

ntr

apar

tum

deat

hs,

1 n

eon

atal

deat

h,

37

ad

mit

ted

to

NIC

U,

4 n

eon

ata

l se

izu

re (

1.9

per

10

00

) -G

reat

er d

ecr

eas

e am

on

g p

ati

ents

of

Un

iver

sity

fac

-u

lty

th

an p

atie

nts

fro

m H

MO

or

pri

vate

pra

cti

ce

-Th

e in

cid

ence

of

CS

fo

r in

dic

ati

on

of

dy

sto

cia

in n

ull

ipar

ou

s w

om

en m

ay b

e r

e-d

uce

d b

y A

ML

. N

OT

ES

: b

efo

re-a

fter

des

ign

can

no

t is

ola

te

the

effe

cts

of

specif

ic c

om

po

nen

ts o

f an

AM

L p

oli

cy

Wo

rk G

rou

p's

Co

mm

ents

: d

id s

am

ple

siz

e a

na

lysi

s to

dete

ct a

t le

ast

a 2

0%

rela

tive

de-

crea

se i

n i

nci

den

ce

of

CS

betw

een

co

ntr

ol

an

d i

nit

ial

AM

L p

erio

d w

ith

90

% p

ow

er a

t

p=

0.0

5


www.icsi.org

51


Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

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tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

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fid

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inte

rval

, re

lati

ve r

isk

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dd

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, li

kel

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nee

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tre

at)

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tho

rs' C

on

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ork

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up

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om

men

ts (

ita

lici

zed

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rner

, B

rass

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& G

ord

on

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8)

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is-

tori

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on

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ith

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r co

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al h

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te

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nit

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ng

use

d r

ou

tin

ely

-D

ura

tio

n o

f la

bo

r w

as f

rom

ti

me

of

adm

issi

on

to

deli

ver

y

suit

e in

lab

or

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de

of

Deli

ver

y:

S

po

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us

Lab

or

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du

ced

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or

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l

(

n=

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4)

(n

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(n=

10

00

) N

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al

8

1%

7

1%

7

7%

L

ow

Cav

ity

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rc. 1

3%

1

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1

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nal

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3

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ad C

S f

or

dy

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fo

r fe

tal

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tres

s;

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% f

or

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halo

pelv

ic d

isp

rop

ort

ion

; 0

.2%

fo

r co

rd

pro

lap

se

-Th

ere

wer

e n

o C

S f

or

dy

sto

cia

aft

er s

po

nta

neo

us

on

set

of

lab

or;

13

aft

er i

nd

uced

lab

or

-O

xy

toci

n u

sed

du

rin

g 1

st s

tag

e fo

r 3

1%

an

d d

uri

ng

2

nd

sta

ge

for

13

%

-4%

wer

e in

lab

or

for

>1

2 h

rs

-No

in

trap

artu

m f

eta

l d

eath

s; 1

neo

nat

al d

eath

du

e t

o

con

gen

ital

hear

t le

sio

n;

1 d

eath

11

day

s p

ost

par

tum

d

ue

to p

erin

ata

l as

ph

yx

ia (

rela

ted

to

use

of

ox

yto

cin

d

esp

ite

feta

l d

istr

ess

); n

o n

eon

ata

l se

izu

res

-Co

mp

ared

to

data

fro

m p

rev

iou

s 4

year

s: fe

wer

CS

(p

<0

.05

); f

ewer

CS

fo

r d

yst

ocia

(p

<0

.05

); n

o i

n-

crea

ses

in p

erin

atal

mo

rtal

ity

-In

tro

du

ctio

n o

f ac

tiv

e m

anag

emen

t w

as a

s-so

ciat

ed w

ith

a 4

to

5%

red

uct

ion

in

CS

in

n

ull

ipar

ou

s w

om

en w

ith

no

ev

iden

ce

of

in-

crea

sed

per

inata

l m

ort

alit

y o

r m

orb

idit

y.

NO

TE

S:

co

mp

ared

dat

a fr

om

th

e s

tud

y p

e-

rio

d t

o d

ata

fro

m p

rev

iou

s 4

year

s –

th

e d

ata

fro

m t

he s

tud

y p

erio

d i

nclu

ded

data

fro

m p

a-ti

ents

wh

o w

ere

no

t act

ively

man

aged

(6

8%

o

f th

e d

eliv

erie

s d

uri

ng

th

e st

ud

y p

erio

d

wer

e to

wo

men

in

acti

ve

mg

mt

pro

toco

l)

Ak

ou

ry,

Bro

die

, C

add

ick

, M

cLau

gh

lin

, &

P

ug

h (

19

88

)

No

n-

Ran

-d

om

/ H

is-

tori

cal

Co

n-

tro

ls

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–

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2 c

on

secu

tiv

e n

ull

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s w

om

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n s

po

nta

neo

us

lab

or

at

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7 w

ks

wit

h n

o f

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l d

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ess

on

ad

mis

sio

n;

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was

co

n-

firm

ed b

y o

bje

ctiv

e f

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ing

s

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ss o

f la

bo

r m

on

ito

red

by

p

elv

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ev

ery

2 h

rs

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yto

cin

au

gm

enta

tio

n i

f ce

r-v

ix f

ail

ed t

o d

ilate

!1

cm

/hr

-Des

cen

t o

f h

ead

mo

nit

ore

d i

n

2n

d s

tag

e o

f la

bo

r -C

on

tin

uo

us

elec

tro

nic

feta

l

hea

rt r

ate

mo

nit

ori

ng

-D

ura

tio

n o

f la

bo

r w

as f

rom

w

hen

pati

ent

adm

itte

d h

erse

lf t

o

the

lab

or

suit

e

-His

tori

cal

co

ntr

ols

wer

e 5

33

nu

llip

aro

us

pat

ien

ts

adm

itte

d t

o t

he

sam

e fa

cil

ity

in

a s

imil

ar t

ime

per

iod

p

rio

r to

th

e s

tud

y p

erio

d;

char

ts w

ere r

evie

wed

wit

h

sam

e in

clu

sio

n/e

xclu

sio

n c

rite

ria a

s th

e st

ud

y g

rou

p

-Ou

tco

mes

(al

l p

<0

.00

5):

S

tud

y G

rou

p C

on

tro

l G

rou

p

Caes

area

n

2

4 (

4%

)

67

(1

3%

) F

orc

eps

del

iver

y

1

07

(1

9%

)

1

55

(2

9%

) L

abo

r >

12

hrs

3

7 (

7%

)

10

9 (

20

%)

-Per

inata

l o

utc

om

es (

AP

GA

R s

core

, N

ICU

ad

mis

-si

on

fo

r >

24

hrs

, h

yp

erb

ilir

ub

inem

ia,

meco

niu

m a

s-p

irat

ion

, ce

ph

alh

em

ato

ma,

seiz

ure

s an

d m

ort

alit

y)

wer

e co

mp

arab

le i

n b

oth

gro

up

s; u

se o

f ep

idu

ral

an-

alg

esi

a w

as c

om

par

able

(2

4%

in

stu

dy

gro

up

an

d

26

% i

n c

on

tro

l g

rou

p);

on

ly d

iffe

ren

ce w

as

in u

se o

f o

xy

toci

n (

41

% o

f st

ud

y g

rou

p a

nd

16

% o

f co

ntr

ol

gro

up

; p

<0

.00

5)

-Act

ive

man

agem

ent

of

lab

or

in n

ull

ipar

ou

s w

om

en r

edu

ced

th

e d

ura

tio

n o

f la

bo

r, t

he

use

of

forc

eps,

an

d t

he

rate

of

Cae

sare

an d

e-li

ver

ies

(CS

) w

ith

no

in

crea

se i

n p

erin

ata

l m

orb

idit

y a

nd

mo

rtali

ty.

52


Support for Implementation:

Management of Labor

Copyright © 2009 by Institute for Clinical Systems Improvement

This section provides resources, strategies and measurement specifications for use in closing the gap between current clinical practice and the recommendations set forth in the guideline.

The subdivisions of this section are:

• Priority Aims and Suggested Measures

- Measurement Specifications

• Key Implementation Recommendations

• Knowledge Resources

• Resources Available


www.icsi.org

53

Priority Aims and Suggested Measures

1. Increase the percentage of women with PTL and/or PTB who receive antenatal corticosteroids appro-priately.

Possible measures of accomplishing this aim:

a. Percentage of mothers with PTL who were given appropriate antenatal corticosteroids during labor.

b. Percentage of mothers with PTB who were given appropriate antenatal corticosteroids during labor.

2. Prevent unnecessary protracted labor with use of Management of Labor Dystocia algorithm and annota-tions and its methods.

Possible measure of accomplishing this aim:

a. Percent of women whose time from admission with active labor to evaluation of labor's progress is less than two hours.

3. Increase the use of procedures that assist in progress to vaginal birth.


a. Percent of women in the guideline population who have SROM or early amniotomy.

b. Percent of women in the guideline population with failure to progress diagnosis who have oxytocin.

4. Increase the percentage of women who are assessed for risk status on entry to labor and delivery.

Possible measure of accomplishing this aim:

a. Percentage of women who are assessed for risk status on entry to labor and delivery.

5. Increase the use of remedial techniques that resolve temporary abnormal fetal heart tracing in labor.


a. Among those who had begun oxytocin and with abnormal FHR tracing, the percentage of births with discontinuance of oxytocin.

b. Percentage of births with amnioinfusion when any of the following is present: thick meconium, repetitive severe variable decelerations or oligohydramnios.

6. Perform an appropriate evaluation for persistent abnormal heart rate tracing in labor before Caesarean.


a. Percentage of births with either scalp stimulation, scalp pH or vibroacoustic stimulation of those births with intervention for abnormal FHR tracing.

b. Percentage of Caesarean deliveries.



www.icsi.org

54

Measurement Specifications

Possible Success Measure # 3a Percent of women in the guideline population who have SROM or early amniotomy.

Population Definition All women giving birth who are:

• full term (36 completed weeks),• nullipara,• without concomitant medical problems,• having contractions,• singleton fetus,• cephalic presentation,• no evidence of fetal distress, and• expected to have a normal spontaneous vaginal delivery.

Data of Interest # among the denominator with either SROM or early amniotomy

# of women giving birth included in the population definition above

Numerator/Denominator Definitions Numerator: All births among denominator with no intact membrane at beginning of active labor. This is accomplished either by either SROM or amniotomy.

Denominator: All births by women who are covered in the guideline as described by: nullipara female, without concomitant medical problems, at term pregnancy (36 completed weeks), having contractions, singleton fetus, cephalic presentation, no evidence of fetal distress, expected normal spontaneous vaginal delivery.

Method/Source of Data Collection Any one of several possible data collection methods may be used by the medical group to capture data for this particular population.

1. Data may be obtained retrospectively by a chart audit (using a minimum sample of 20 charts per month).

2. Data may be obtained through discharge abstract coding or other data base from the hospital.

3. The hospital may send the medical group a copy of the labor and delivery summary sheet for deliv-eries.

4. A copy of the nursing checklist form is sent to the medical group for data collection.

Data are reviewed to determine if the delivery fits the inclusion criteria for the measure. If no, the birth is not reviewed. If yes, the birth data are reviewed to assess if amniotomy or SROM occurred and whether oxytocin was used.

Management of Labor Priority Aims and Suggested Measures Third Edition/May 2009


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55

Time Frame Pertaining to Data Collection It is suggested that these data are collected monthly.

Notes This is the rate where the membrane is not present in active labor. The absence of membranes at the begin-ning of labor helps progress to vaginal birth. This rate should increase.



www.icsi.org

56

Possible Success Measure #3b Percent of women in the guideline population with failure to progress diagnosis who have oxytocin.

Population Definition All women giving birth who are:

• full term (36 completed weeks), • nullipara,• without concomitant medical problems, • having contractions,• singleton fetus,• cephalic presentation, • no evidence of fetal distress, and • expected to have a normal spontaneous vaginal delivery.

Data of Interest # of births with oxytocin among the denominator

# of births to guideline women with failure to progress diagnosis

Numerator/Denominator Definitions Numerator: # of births of denominator where oxytocin is used.

Denominator: # of births to women covered in the guideline as described by: nullipara female, without concomitant medical problems, at term pregnancy (36 completed), having contractions, singleton fetus, cephalic presentation, no evidence of fetal distress, expected normal spontaneous vaginal delivery and diagnosis of failure to progress.

Method/Source of Data Collection Any one of several possible data collection methods may be used by the medical group to capture data for this particular population.

1. Data may be obtained retrospectively by a chart audit (using a minimum sample of 20 charts per month).

2. Data may be obtained through discharge abstract coding or other data base from the hospital. Then the hospital can relay data for a medical group's deliveries.

3. The hospital may send the medical group a copy of the labor and delivery summary sheet for deliv-eries.

4. A copy of the nursing checklist form is sent to the medical group for data collection.

Data are reviewed to determine if the delivery fits the inclusion criteria for the measure. If no, the birth is not reviewed. If yes, the birth data are reviewed to assess if amniotomy or SROM occurred and whether oxytocin was used.

Time Frame Pertaining to Data Collection It is suggested that these data are collected monthly.



www.icsi.org

57

Possible Success Measure #4a Percentage of women who are assessed for risk status on entry to labor and delivery.

Population Definition All women who present in labor.

Data of Interest # of women who are assessed for risk status on entry to labor and delivery

total # of women whose medical records are reviewed

Numerator/Denominator Definitions Numerator: # of women with evidence of assessment for risk status on entry to labor and delivery to include:

• 20-minute fetal heart rate (FHR) assessment,• patient assessment,• prenatal risk review, and• risk in labor assessment.

Denominator: # of women who present in labor.

Method/Source of Data Collection Any one of several possible data collection methods may be used by the medical group to capture data for this population.

1. Data may be obtained retrospectively by a chart audit (using a minimum sample of 20 charts per month) of all women presenting in labor.


3. The hospital may send the medical group a copy of the labor and delivery summary sheet.

Time Frame Pertaining to Data Collection Suggested time frame for data collection is monthly.

Notes Risk assessment should be performed on all patients in active labor and is the responsibility of all members of the health care team. That includes, but is not limited to nurses, midwives and physicians.



www.icsi.org

58

Possible Success Measure #5b Percentage of births with amnioinfusion when either of the following is present: thick meconium or repeti-tive severe variable decelerations or oligohydramnios.

Data of Interest # of women who have amnioinfusion

# of women giving birth who have one or more of the following present: thick meconium and repetitive severe variable decelerations and/or prolonged decelerations

Numerator/Denominator Definitions Numerator: # of eligible births with amnioinfusion.

Denominator: # of births having one or more of the following present: thick meconium, repetitive severe variable decelerations or oligohydramnios. In the case of multiple births at a delivery, the birth event is counted once.

Method/Source of Data Collection Any one of several possible data collection methods may be used by the medical group to capture data for this population.

1. Data may be obtained retrospectively by a chart audit (using a minimum sample of 20 charts per month as defined by denominator above.)


3. The hospital may send the medical group a copy of the labor and delivery summary sheet.

4. A copy of the nursing checklist form is send to the medical group for data collection.

Data are reviewed to determine if the delivery fits the inclusion criteria for the measure. If no, the birth is not reviewed. If yes, the birth data are reviewed to assess whether an amnioinfusion was performed.

Time Frame Pertaining to Data Collection These data will be collected monthly.

Notes Amnioinfusion for fetal stress may be performed if operative delivery is contemplated. It is expected that the amnioinfusion rate will increase.



www.icsi.org

59

Knowledge Resources

Criteria for Selecting ResourcesThe following resources were selected by the Management of Labor guideline work group as addi-tional resources for providers and/or patients. The following criteria were considered in selecting these resources.

• The site contains information specific to the topic of the guideline.

• The content is supported by evidence-based research.

• The content includes the source/author and contact information.

• The content clearly states revision dates or the date the information was published.

• The content is clear about potential biases, noting conflict of interest and/or disclaimers as appropriate.

Resources Available to ICSI Members OnlyICSI has a wide variety of knowledge resources that are only available to ICSI members (these are indicated with an asterisk in far left-hand column of the Resources Available table). In addition to the resources listed in the table, ICSI members have access to a broad range of materials including tool kits on CQI processes and Rapid Cycling that can be helpful. To obtain copies of these or other Knowledge Resources, go to http://www.icsi.org/improvement_resources. To access these materials on the Web site, you must be logged in as an ICSI member.

The resources in the table on the next page that are not reserved for ICSI members are available to the public free-of-charge.



www.icsi.org

60

* Author/Organization Title/Description Audience Web Sites/Order InformationAmerican College of Obstetricians & Gynecologists (ACOG)

Preterm Labor (pamphlet 1999) Public 1-800-762-2264 AP087

American College of Obstetricians & Gynecologists (ACOG)

OB/GYN topics Professionals http://www.acog.org


Vaginal Birth After Caesarean (pamphlet)

Public 1-800-762-2264 #AP070


Fetal Heart Rate Monitoring During Labor (pamphlet)

Public 1-800-762-2264 x830; #18015

March of Dimes Includes downloadable fact sheets on a wide variety of topics related to healthy pregnancy and delivery of healthy babies. Fact sheets include prenatal nutrition, healthy lifestyle before, during and after pregnancy, and prevention of birth defects. Q & A option.

Public &Professionals

http://www.marchofdimes.com

Toll-free number also available for direct contact with the March of Dimes: 1-888-MODIMES (663-4637)

March of Dimes Preventing Preterm Labor Public 1-800-367-6630 #09-754-00

March of Dimes Premature Labor: A Teaching Guide Public 1-800-367-6630 English #33-205-03 Spanish #33-205-04

March of Dimes Learn the Signs of Preterm Labor (flyer)

Public 1-800-367-6630 English #09-1099-98; Spanish #09-1100-98

Mayo Clinic Includes alphabetical listings of con-ditions as well as search capabilities for information on specific areas of health care including many aspects of prenatal care.

Public http://www.mayoclinic.com

National Women's Health Informa-tion Center/Office of Women's Health, U.S. Dept. of Health and Human Services

Provides information on many preg-nancy-related topics including nutrition and fitness, prevention of birth defects and complications of pregnancy, and financial assistance. Also provides information on preparing for childbirth and tips on caring for a newborn. In English and Spanish.

Public http://www.womanshealth.gov/ pregnancy

Call 1-800-994-Woman (1-800-994-9662) or 1-888-220-5546 for the hearing impaired.

Resources Available


* Available to ICSI members only.

I I CS Health Care Guideline: Management of Labor · 2012-09-08 · Health Care Guideline:...

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