Miscarriage Miscarriage Management Training Management Training

InitiativeInitiative

Management of Early Pregnancy LossManagement of Early Pregnancy Loss

Sarah Prager, MDSarah Prager, MDDepartment of Obstetrics and GynecologyDepartment of Obstetrics and Gynecology

University of WashingtonUniversity of Washington

MM-TI Goals:MM-TI Goals:

Move miscarriage management from the Move miscarriage management from the operating room to the outpatient settingoperating room to the outpatient setting

Train primary care clinicians and support staff Train primary care clinicians and support staff in miscarriage managementin miscarriage management

PurposePurpose

Expand patient access to prompt, appropriate Expand patient access to prompt, appropriate carecare

Improve patient safetyImprove patient safety Improve patient satisfactionImprove patient satisfaction Decrease costsDecrease costs

Challenges and SolutionsChallenges and Solutions

Difficult to influence physician practice Difficult to influence physician practice patternspatterns

Target training during residencyTarget training during residency

Use a systems approach (include faculty, Use a systems approach (include faculty, residents, key administrative personnel residents, key administrative personnel and support staff) and support staff)

ClarificationClarification

We are not talking about elective abortion We are not talking about elective abortion We are teaching and promoting We are teaching and promoting miscarriagemiscarriage

managementmanagement

MVA Safety and Efficacy: MVA Safety and Efficacy: SummarySummary

MVA is simpleMVA is simpleEasily incorporated into office settingEasily incorporated into office settingExpanded pain management optionsExpanded pain management optionsUltrasound as neededUltrasound as neededPatient-provider interactionPatient-provider interaction

Management of Early Management of Early Pregnancy LossPregnancy Loss

ObjectivesObjectives Review etiologies of EPLReview etiologies of EPL Review the three methods of EPL Review the three methods of EPL

management:management:— Expectant— Expectant— Medical— Medical— Surgical— Surgical

Discuss benefits of outpatient EPL Discuss benefits of outpatient EPL managementmanagement

NomenclatureNomenclatureManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

Early Pregnancy Loss (EPL)Early Pregnancy Loss (EPL)Spontaneous Abortion (SAb)Spontaneous Abortion (SAb)

MiscarriageMiscarriage

These all mean exactly the same thing!These all mean exactly the same thing!

BackgroundBackgroundManagement of Early Pregnancy LossManagement of Early Pregnancy Loss Spontaneous Abortion (SAb) most common Spontaneous Abortion (SAb) most common

complication of early pregnancycomplication of early pregnancy— 8–20% clinically recognized pregnancies— 8–20% clinically recognized pregnancies— 13–26% all pregnancies— 13–26% all pregnancies

— — ~ 800,000 SABs each year in the US~ 800,000 SABs each year in the US

80% of SAbs occur in 1st trimester80% of SAbs occur in 1st trimester

SamanthaSamantha

26 yo G2P1 26 yo G2P1 presents to your presents to your office for a new ob office for a new ob visit. An visit. An ultrasound sows a ultrasound sows a CRL of 7mm but no CRL of 7mm but no cardiac activity.cardiac activity.

She wants to know She wants to know why this happened.why this happened.

Risk FactorsRisk FactorsManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

AgeAgePrior SAbPrior SAbSmokingSmokingAlcoholAlcohol

Caffeine Caffeine (controversial)(controversial)Maternal BMI <18.5 or >25 Maternal BMI <18.5 or >25 Celiac disease Celiac disease (untreated)(untreated)

CocaineCocaineNSAIDsNSAIDs

High gravidityHigh gravidityFeverFever

Low folate levelsLow folate levels

EtiologyEtiologyManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

33% anembryonic33% anembryonic 50% due to chromosomal abnormalities50% due to chromosomal abnormalities

— Autosomal trisomies — Autosomal trisomies 52%52%— Monosomy X — Monosomy X 19%19%— Polyploidies — Polyploidies 22%22%— Other — Other 7%7%

Host factorsHost factors— Structural abnormalities— Structural abnormalities— Maternal infection/endocrinopathy/coagulopathy— Maternal infection/endocrinopathy/coagulopathy

UnexplainedUnexplained

Normal Implantation & DevelopmentNormal Implantation & DevelopmentManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

Implantation: Implantation: — 5-7 days after fertilization— 5-7 days after fertilization— Takes ~72 hours— Takes ~72 hours— Invasion of trophoblast — Invasion of trophoblast

into deciduainto decidua

Embryonic disc: Embryonic disc: — 1 wk post-implantation — 1 wk post-implantation — If no embryonic disc, trophoblast still grows, — If no embryonic disc, trophoblast still grows,

but no embryo but no embryo (anembryonic pregnancy)(anembryonic pregnancy)

Embryonic disc embryonic/fetal poleEmbryonic disc embryonic/fetal pole

U/S Dating in Normal PregnancyU/S Dating in Normal PregnancyManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

Gestational Age (days)

Mean Sac Diameter(mm) + 30

OR

Crown-Rump Length(mm) + 42

=

Clinical Presentation of EPLClinical Presentation of EPLManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

BleedingBleeding Pain/crampingPain/cramping Falling or abnormally rising ßhCGFalling or abnormally rising ßhCG Decreased symptoms of pregnancyDecreased symptoms of pregnancy No symptoms at all!No symptoms at all!

Ultrasound Findings of EPLUltrasound Findings of EPLManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

Anembryonic PregnancyAnembryonic Pregnancy— No fetal pole with mean sac diam — No fetal pole with mean sac diam

>25 mm >25 mm (transabdominal)(transabdominal) OR OR>18 mm >18 mm (transvaginal)(transvaginal)

— <4 mm growth in 7 days— <4 mm growth in 7 days(No yolk sac, with mean sac diameter >10 mm)(No yolk sac, with mean sac diameter >10 mm)

Embryonic DemiseEmbryonic Demise— No cardiac activity with CRL ≥5 mm— No cardiac activity with CRL ≥5 mm

Mishell DR, Comprehensive Gynecology 2007

SamanthaSamantha

Samantha and her partner request Samantha and her partner request information on all the treatment information on all the treatment options. You confirm the rest of her options. You confirm the rest of her history.history.

PMH: wisdom teeth removedPMH: wisdom teeth removed

Ob Hx: term SVD without complicationOb Hx: term SVD without complication

All: NKDAAll: NKDA

Management OptionsManagement OptionsEarly Pregnancy LossEarly Pregnancy Loss

Do Nothing:Do Nothing:Expectant managementExpectant management

Do Something:Do Something: Medical Medical managementmanagement

Do Surgery:Do Surgery:Surgical managementSurgical management

Sotiriadis A, Obstet Gynecol 2005Nanda K, Cochrane Database Syst Rev 2006

Do NothingDo NothingExpectant ManagementExpectant Management

Requirements for therapy:Requirements for therapy:— <13 weeks gestation— <13 weeks gestation— Stable vital signs— Stable vital signs— No evidence infection— No evidence infection

What to expect:What to expect:— Most expel within 1st 2 wks after diagnosis — Most expel within 1st 2 wks after diagnosis — Prolonged follow-up may be needed— Prolonged follow-up may be needed— Acceptable and safe to wait up to 4 wks — Acceptable and safe to wait up to 4 wks post-diagnosispost-diagnosis

OutcomesOutcomesDo Nothing: Expectant ManagementDo Nothing: Expectant Management

Overall success rateOverall success rate 81%81%

Success rates vary by type of miscarriageSuccess rates vary by type of miscarriage(helpful to tailor counseling)(helpful to tailor counseling)— Incomplete/inevitable abortion— Incomplete/inevitable abortion 91%91%— Embryonic demise— Embryonic demise 76%76%— Anembryonic pregnancies— Anembryonic pregnancies 66%66%

Luise C, Ultrasound Obstet Gynecol 2002

What is Success?What is Success?Definitions Used in StudiesDefinitions Used in Studies

≤≤15 mm endometrial thickness (ET)15 mm endometrial thickness (ET)3 days to 6 weeks after diagnosis3 days to 6 weeks after diagnosis

No vaginal bleedingNo vaginal bleeding Negative urine hCGNegative urine hCG

Problems with ET Cut-offProblems with ET Cut-off No clear rationale for this cut-offNo clear rationale for this cut-off Study of 80 women with successful medical Study of 80 women with successful medical

abortionabortion— Mean ET at 24 hours 17.5 mm (7.6–29 mm)— Mean ET at 24 hours 17.5 mm (7.6–29 mm)— At one week 15% with ET >16 mm— At one week 15% with ET >16 mm

Study of medical management after Study of medical management after miscarriagemiscarriage— 86% success rate if use absence — 86% success rate if use absence

of gestational sacof gestational sac— 51% success rate if use ET ≤15 mm— 51% success rate if use ET ≤15 mm

Harwood B, Contraception 2001Reynolds A, Eur. J Obstet Gynecol Reproduct. Biol 2005

When to interveneWhen to intervenefor Expectant Management?for Expectant Management? Continued gestational sacContinued gestational sac Clinical symptomsClinical symptoms Patient preferencePatient preference Time (?)Time (?)

Vaginal bleeding and positive UPT Vaginal bleeding and positive UPT are possible for 2–4 weeksare possible for 2–4 weeks— Poor measures of success— Poor measures of success

SamanthaSamantha

Samantha appears anxious about waiting Samantha appears anxious about waiting and shares with you that she really needs to and shares with you that she really needs to do something. do something.

Do SomethingDo SomethingMedical ManagementMedical Management

MisoprostolMisoprostol Misoprostol + MifepristoneMisoprostol + Mifepristone Misoprostol + MethotrexateMisoprostol + Methotrexate

No medical regimen for managementNo medical regimen for managementof EPL is FDA approvedof EPL is FDA approved

Medical ManagementMedical ManagementRequirement for TherapyRequirement for Therapy

<13 weeks gestation<13 weeks gestation

Stable vital signsStable vital signs

No evidence of infectionNo evidence of infection

No allergies to medications usedNo allergies to medications used

Adequate counseling and patientAdequate counseling and patient acceptance of side effects acceptance of side effects

MisoprostolMisoprostol Prostoglandin E1 analogueProstoglandin E1 analogue FDA approved for prevention FDA approved for prevention

of gastric ulcersof gastric ulcers Used off-label for many Ob/Gyn indications:Used off-label for many Ob/Gyn indications:

— Labor induction— Labor induction— Cervical ripening— Cervical ripening— Medical abortion — Medical abortion (with mifepristone)(with mifepristone)— Prevention/treatment of postpartum — Prevention/treatment of postpartum hemorrhagehemorrhage

Can be administered by oral, buccal, sublingual, Can be administered by oral, buccal, sublingual, vaginal and rectal routesvaginal and rectal routes

Chen B, Clin Obstet Gynecol 2007

Why Misoprostol?Why Misoprostol? Do something while still avoiding surgeryDo something while still avoiding surgery Cost effectiveCost effective Stable at room temperatureStable at room temperature Readily availableReadily available

Misoprostol Dosing RegimensMisoprostol Dosing RegimensEmbryonic Demise & Anembryonic PregnancyEmbryonic Demise & Anembryonic PregnancyStudyStudy DoseDose EfficacyEfficacy

CreininCreinin 400 mcg po vs 800 pv400 mcg po vs 800 pv 25% vs. 88%25% vs. 88%

NgocNgoc 800 mcg po vs 800 pv800 mcg po vs 800 pv 89% vs. 93% (NS)89% vs. 93% (NS)

TangTang 600 mcg SL vs 600 pv600 mcg SL vs 600 pv 87.5%87.5%q 3 hrs x 3 dosesq 3 hrs x 3 doses(SL had more side effects—(SL had more side effects—diarrhea, 70% vs 27.5%)diarrhea, 70% vs 27.5%)

PhupongPhupong 600 mcg po x 1 vs. 600 mcg po x 1 vs. 82% vs 92% (NS)82% vs 92% (NS)q 4 hrs x 2 dosesq 4 hrs x 2 doses(Repeat dosing increased (Repeat dosing increased diarrhea, 40% vs 18%)diarrhea, 40% vs 18%)

GillesGilles 800 mcg pv saline-800 mcg pv saline- 83% vs 87% (NS)83% vs 87% (NS)moistened vs. drymoistened vs. dry

Creinin MD, Obstet Gynecol 1997; Ngoc NTN, Int.J Gynaecol Obstet 2004; Tang OS, Hum Reproduct 2003; Phupong V, Contraception 2005; Gilles JM, Am J Obstet Gynecol 2004

Pooled OutcomesPooled OutcomesMedical ManagementMedical Management

Success RatesSuccess Rates

PlaceboPlacebo 16–60%16–60%

Single dose misoprostol Single dose misoprostol 25–88% 25–88% 400–800 mcg400–800 mcg

Repeat dose x 1 if incomplete Repeat dose x 1 if incomplete 80–88% 80–88% at 24 hoursat 24 hours

Wood SL, Obstet Gynecol 2002; Bagratee JS, Hum Reproduct 2004; Blohm F, BJOG: Int J Obstet Gynecol 2005

Success rate depends on type of miscarriageSuccess rate depends on type of miscarriage— 100% with incomplete abortion— 100% with incomplete abortion— 87% for all others— 87% for all others

Serum Level ComparisonSerum Level ComparisonMisoprostol by Route of AdministrationMisoprostol by Route of Administration

0

100

200

300

400

500

600

0 30 60 90 120 150 180 210 240 270 300

Minutes

Se

rum

Le

ve

l (p

g/m

L)

Vaginal - Zieman

Vaginal - Tang

Buccal - Meckstroth

Sublingual - Tang

Oral - Zieman

Uterine Tone Over 5 HoursUterine Tone Over 5 HoursMisoprostol by Route of AdministrationMisoprostol by Route of Administration

Rectal p = .0060

10

20

30

40

50

60

70

0 30 60 90 120 150 180 210 240 270 300

Time (min)

Ute

rin

e T

on

e (m

mH

g)

Vaginal DryVaginal MoistBuccalRectal

Meckstroth, not yet published

Uterine Activity Over 5 HoursUterine Activity Over 5 HoursMisoprostol by Route of AdministrationMisoprostol by Route of Administration

0

200

400

600

800

1000

1200

1400

1600

1800

2000

0 30 60 90 120 150 180 210 240 270 300

Time (min)

Ute

rin

e A

ctiv

ity

(AU

)

Vaginal DryVaginal MoistBuccalRectal

Meckstroth, not yet published

Side Effects and ComplicationsSide Effects and ComplicationsMisoprostol vs. PlaceboMisoprostol vs. Placebo

N/V, Diarrhea:N/V, Diarrhea: No differenceNo difference

Pain:Pain: More pain and analgesics More pain and analgesics in one studyin one study

Hemoglobin Conc:Hemoglobin Conc: No differenceNo difference

Infection:Infection: 0% for placebo vs. 0% for placebo vs. .2–4.7% for misoprostol.2–4.7% for misoprostol

No benefit with repeat dosing within 3–4 hoursNo benefit with repeat dosing within 3–4 hours Improved outcome with 1 repeat dose Improved outcome with 1 repeat dose at 24 hours, if incomplete at 24 hours, if incomplete 90% found medical management acceptable90% found medical management acceptable and would elect same treatment again and would elect same treatment again

Wood SL, Obstet Gynecol 2002; Bagratee JS, Hum Reproduct 2004; Blohm F, BJOG: Int J Obstet Gynecol 2005

Misoprostol Bottom LineMisoprostol Bottom LineMedical ManagementMedical Management

800 mcg pv 800 mcg pv (or buccal)(or buccal) Repeat x 1 at 12–24 hours, Repeat x 1 at 12–24 hours,

if incompleteif incomplete— Occasionally repeat more than once— Occasionally repeat more than once

Measure success as with expectant Measure success as with expectant managementmanagement

Intervene with surgical management ifIntervene with surgical management if— Continued gestational sac— Continued gestational sac— Clinical symptoms— Clinical symptoms— Patient preference— Patient preference— Time (?)— Time (?)

Mifepristone and MisoprostolMifepristone and Misoprostol Medical ManagementMedical Management

Mifepristone:Mifepristone: Progestin antagonist that binds Progestin antagonist that binds to progestin receptorto progestin receptor

— Used with elective medical abortion to — Used with elective medical abortion to “destabilize” “destabilize” implantation siteimplantation site— Current evidence-based regimen: — Current evidence-based regimen:

200 mg mifepristone + 800 mcg misoprostol200 mg mifepristone + 800 mcg misoprostol Success rates for mifepristone & misoprostol in EPL: Success rates for mifepristone & misoprostol in EPL:

— 52–84% — 52–84% (observational trials, non-standard dose)(observational trials, non-standard dose)— 90–93% — 90–93% (standard dose)(standard dose)

No direct comparison between misoprostol alone No direct comparison between misoprostol alone and mifepristone/misoprostol with standard dosing and mifepristone/misoprostol with standard dosing

Mifepristone may help Mifepristone may help (data still pending)(data still pending)Gronlund A, Acta Obstet Gynaecol 1998; Nielsen S, Br J Obstet Gynaecol 1997; Niinimaki M, Fertility Sterility 2006; Schreiber CA, Contraception 2006

Methotrexate and MisoprostolMethotrexate and Misoprostol Medical ManagementMedical Management

Methotrexate:Methotrexate: — Folic acid antagonist — Folic acid antagonist— Cytotoxic to trophoblast— Cytotoxic to trophoblast

Used in medical management for ectopic Used in medical management for ectopic pregnancypregnancy

Introduced in 1993 in combination with Introduced in 1993 in combination with misoprostol to treat elective abortion misoprostol to treat elective abortion medically medically — Success rates up to 98% — Success rates up to 98% (misoprostol (misoprostol administered 7 days after methotrexate)administered 7 days after methotrexate)

No data for use in early pregnancy lossNo data for use in early pregnancy lossCreinin MD, Contraception 1993

SamanthaSamantha

Samantha opts to try misoprostol and Samantha opts to try misoprostol and returns to the office 7 days later for returns to the office 7 days later for follow up. How do you assess whether follow up. How do you assess whether or not her treatment is complete?or not her treatment is complete?

SamanthaSamantha

At her follow-up appointment, Samantha At her follow-up appointment, Samantha says that she had a period of heavy says that she had a period of heavy bleeding and is now spotting. Her bleeding and is now spotting. Her cramping has resolved. She has noted cramping has resolved. She has noted a marked decrease in breast a marked decrease in breast tenderness and nausea.tenderness and nausea.

Her ultrasound shows a uniform Her ultrasound shows a uniform endometrial stripe measuring 30mm in endometrial stripe measuring 30mm in its greatest width.its greatest width.

Is she complete? Is she complete?

SamanthaSamantha

RebeccaRebecca

32 yo G3P2 at 8 weeks by LMP was 32 yo G3P2 at 8 weeks by LMP was diagnosed with a fetal demise on her diagnosed with a fetal demise on her ultrasound and presents to your office ultrasound and presents to your office after 2 weeks of expectant after 2 weeks of expectant management stating that she “wants to management stating that she “wants to be done”. She declines medical be done”. She declines medical management and requests a D&C.management and requests a D&C.

RebeccaRebecca

What questions would you ask to see if What questions would you ask to see if she was a good candidate? she was a good candidate?

Surgical ManagementSurgical ManagementEarly Pregnancy LossEarly Pregnancy Loss

Suction dilation and curettage (D&C)Suction dilation and curettage (D&C)

Who should have surgical management?Who should have surgical management?— Unstable— Unstable— Significant medical morbidity— Significant medical morbidity— Infected— Infected— Very heavy bleeding— Very heavy bleeding— Anyone who WANTS immediate therapy— Anyone who WANTS immediate therapy

Surgical ManagementSurgical ManagementEarly Pregnancy LossEarly Pregnancy Loss

Convenient timingConvenient timing

Observed therapyObserved therapy

High success rates High success rates (almost 100%)(almost 100%)

Infection (1/200)Infection (1/200)

Perforation (1/2000)Perforation (1/2000)

Cervical traumaCervical trauma

Uterine synechiaeUterine synechiae(very rare)(very rare)

BENEFITSBENEFITS RISKSRISKS

Infection ProphylaxisInfection ProphylaxisSurgical ManagementSurgical Management

Periabortal antibiotics Periabortal antibiotics infection risk 42% infection risk 42% No strong evidence on what to useNo strong evidence on what to use Doxycycline Doxycycline (2–14 doses)(2–14 doses) Metronidazole:Metronidazole: — Bacterial vaginosis— Bacterial vaginosis

— Trichomoniasis— Trichomoniasis— Suspicious discharge— Suspicious discharge

Sawaya GF, Obstet Gynecol 1996; Prieto JA, Obstet Gynecol 1995

Comparison of Outcome by MethodComparison of Outcome by MethodManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

FactorFactor Comparison of MethodsComparison of Methods

Success rateSuccess rate Surgical > MedicalSurgical > MedicalMedical ≥ ExpectantMedical ≥ Expectant

Resolution Resolution Surgical > Medical > Expectant Surgical > Medical > Expectant within 48 hrswithin 48 hrs

Infection riskInfection risk Expectant = Medical = SurgicalExpectant = Medical = Surgical.2–3%.2–3%

Nanda K, Cochrane Database Syst Rev 2006; Nielsen S, Br J Obstet Gynaecol 1999; Shelly JM, Aust. NZ J Obstet Gynaecol 2005; Sotiriadis A, Obstet Gynecol 2005; Tinder J, (MIST) BMJ, 2006

Number differed by highly Number differed by highly variable success rates variable success rates reported for expectant reported for expectant managementmanagement

Patient SatisfactionPatient SatisfactionManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

Meta-analysis shows studies report high Meta-analysis shows studies report high satisfaction with medical managementsatisfaction with medical management

Caution:Caution: Few studies looked at satisfaction Few studies looked at satisfaction Satisfaction depended on choice:Satisfaction depended on choice:

— If women randomized — If women randomized 55-74% satisfied55-74% satisfied— If women chose — If women chose 84-88% satisfied84-88% satisfied— Both were independent of method— Both were independent of method

Unsuccessful expectant resulting in surgical Unsuccessful expectant resulting in surgical showed most profound anxiety and showed most profound anxiety and depressiondepression

Sotiriadis 2005

Zhang, NEJM 2005

Cost AnalysisCost AnalysisManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

MedicalMedical management most cost effective management most cost effective— 2 studies— 2 studies— Misoprostol vs. expectant vs. surgical: — Misoprostol vs. expectant vs. surgical:

$1000 vs. $1172 vs. $2007 $1000 vs. $1172 vs. $2007

ExpectantExpectant management most cost effectivemanagement most cost effective— MIST trial— MIST trial— Expectant vs. medical vs. surgical: — Expectant vs. medical vs. surgical:

£1086 vs. £1410 vs. £1585 £1086 vs. £1410 vs. £1585

Doyle NM, Obstet. Gynecol 2004; You JH, Hum Reprod 2005; Petrou S, BJOG 2006

RebeccaRebecca

Refer to OR?Refer to OR?

Manage with MVA?Manage with MVA?

The clinic schedule is packed…does this have The clinic schedule is packed…does this have to be done today? to be done today?

Where to perform?Where to perform?Surgical ManagementSurgical Management

Women with SAb in Canada:Women with SAb in Canada:— 92.5% presenting to hospital have D&C— 92.5% presenting to hospital have D&C— 51% presenting to family physician have D&C— 51% presenting to family physician have D&C

Manual vacuum aspiration (MVA) in outpatient Manual vacuum aspiration (MVA) in outpatient setting can setting can hospital costs by 41% hospital costs by 41%

Weibe E, Fam Med 1998; Finer LB, Perspect Sexu Reproduct Health 2003; Blumenthal PD, Int J Gynaecol Obstet 1994

AdvantagesAdvantagesMoving Rx from OR to Outpatient SettingMoving Rx from OR to Outpatient Setting

Avoid repeated exams that often occur Avoid repeated exams that often occur in hospitalin hospital

Simplify scheduling and reduce wait timeSimplify scheduling and reduce wait time— Average OR waiting time in UK-based study: — Average OR waiting time in UK-based study: 14 hours, with 42% of women not satisfied 14 hours, with 42% of women not satisfied

Save resourcesSave resources Avoid cumbersome OR protocolsAvoid cumbersome OR protocols

— Prolonged NPO requirements and — Prolonged NPO requirements and discharge criteriadischarge criteria

Demetroulis 2001; Lee and Slade 1996

AdvantagesAdvantagesMoving Rx from OR to Outpatient SettingMoving Rx from OR to Outpatient Setting

Office affords more treatment options Office affords more treatment options — Vacuum aspiration or misoprostol— Vacuum aspiration or misoprostol— Pain management choices— Pain management choices

Improved patient autonomy and privacyImproved patient autonomy and privacy ConvenienceConvenience Personalized care Personalized care

Lee and Slade 1996

Moving Incomplete Abortion Moving Incomplete Abortion to Outpatient Settingto Outpatient Setting

Johns Hopkins StudyJohns Hopkins Study

MethodsMethods N = 35, incomplete 1st-trimester abortionN = 35, incomplete 1st-trimester abortion Treatment comparison:Treatment comparison:

Blumenthal and Remsburg 1994

ManualManual ConventionalConventionalvacuumvacuum carecare

aspirationaspiration (suction (suction (MVA)(MVA) curretage) curretage)

L&DL&D OROR

Procedure:Procedure:

Setting:Setting: vs.vs.

Moving Incomplete Abortion Moving Incomplete Abortion to Outpatient Settingto Outpatient Setting

Johns Hopkins StudyJohns Hopkins Study

ResultsResults

Anesthesia requirementsAnesthesia requirements

Overall hospital stay, from 19 6 hoursOverall hospital stay, from 19 6 hours

Patient waiting time by 52%Patient waiting time by 52%

Procedure time, from 33 19 minutesProcedure time, from 33 19 minutes

Costs per case:Costs per case: $1,404 in OR$1,404 in OR$827 in L&D$827 in L&D$200 or less in ER$200 or less in ER

Blumenthal 1994

Use Outpatient Management Use Outpatient Management Cautiously in Women with…Cautiously in Women with… Uterine anomaliesUterine anomalies Coagulation problemsCoagulation problems Active pelvic infection Active pelvic infection Extreme anxietyExtreme anxiety Any condition causing patient Any condition causing patient

to be medically unstableto be medically unstable

What IsWhat Is a Manual Vacuum Aspirator?a Manual Vacuum Aspirator?

Creinin MD, et al. Obstet Gynecol Surv. 2001.; Goldberg AB, et al. Obstet Gynecol. 2004. Hemlin J, et al. Acta Obstet Gynecol Scand. 2001.

Locking valve Portable and reusable Equivalent to electric pump Efficacy same as electric

vacuum (98%–99%) Semi-flexible plastic

cannula

ComparisonComparisonEVA to MVAEVA to MVA

Dean G, et al. Contraception. 2003.

EVAEVA MVAMVA

VacuumVacuum Electric pumpElectric pump Manual aspiratorManual aspirator

NoiseNoise VariableVariable QuietQuiet

PortablePortable Not easilyNot easily YesYes

CannulaCannula 4–16 mm4–16 mm 4–12 mm4–12 mm

CapacityCapacity 350–1,200 cc350–1,200 cc 60 cc60 cc

SuctionSuction ConstantConstant Decreases to 80% (50 mL) Decreases to 80% (50 mL) as aspirator fillsas aspirator fills

Clinical Indications for MVA Clinical Indications for MVA

Uterine evacuation in the first trimester:Uterine evacuation in the first trimester:

Induced abortionInduced abortion

Spontaneous abortion Spontaneous abortion

Incomplete medication abortionIncomplete medication abortion

Uterine samplingUterine sampling

Post-abortal hematometraPost-abortal hematometra

HemorrhageHemorrhage

Creinin MD, et al. Obstet Gynecol Surv. 2001.; Edwards J, Creinin MD. Curr Probl Obstet Gynecol Fertil.1997.; Castleman LD et al. Contraception. 2006; MVA Label. Ipas. 2007.

MVA InstrumentsMVA Instruments

Steps for Performing MVASteps for Performing MVA

A step-by-step poster

is available from the manufacturer to guide clinicians through the procedure

is in your packet - “Performing Manual Vacuum Aspiration (MVA). . .”

Very rare Very rare

Same as EVASame as EVA

May include:May include:— Incomplete evacuation— Incomplete evacuation— Uterine or cervical injury— Uterine or cervical injury— Infection— Infection— Hemorrhage— Hemorrhage— Vagal reaction— Vagal reaction

Complications with MVAComplications with MVA

MVA Label. Ipas. 2004.

MVA vs. EVA Complication MVA vs. EVA Complication RatesRates

MethodsMethods

Vacuum aspiration for abortion up to 10 wks LMPVacuum aspiration for abortion up to 10 wks LMP

Retrospective cohort analysisRetrospective cohort analysis

Choice of method (MVA vs. EVA) up to physicianChoice of method (MVA vs. EVA) up to physician

n = 1,002 for MVA; n = 724 for EVA n = 1,002 for MVA; n = 724 for EVA

Charts reviewed for complicationsCharts reviewed for complications

Goldberg AB, et al. Obstet Gynecol. 2004.

more…

MVA vs. EVA Complication MVA vs. EVA Complication Rates Rates (continued)(continued)

Goldberg AB, et al. Obstet Gynecol. 2004.

Complications

• 2.5% for MVA• 2.1% for EVA (p = 0.56)• No significant difference

more…*Elective not spontaneous studies

MVA vs. EVA Complication MVA vs. EVA Complication Rates Rates (continued(continued))

Goldberg AB, et al. Obstet Gynecol. 2004.

Choice of MVA vs EVA in procedures

• Attendings: 52% MVA

• Gyn residents: 59% MVA

• Other residents: 76% MVA (p<0.001)

MVA and POC: StudyMVA and POC: Study

In group overall In group overall

n = 1,726, up to 10 weeks LMPn = 1,726, up to 10 weeks LMP

Complication rates between MVA and EVAComplication rates between MVA and EVA

37 patients at < 6 weeks’ gestation37 patients at < 6 weeks’ gestation

In 35 of 37, provider chose MVA In 35 of 37, provider chose MVA

No re-aspirations needed in patients < 6 weeksNo re-aspirations needed in patients < 6 weeks

Goldberg AB, et al. Obstet Gynecol. 2004.

more…

MVA and POC: Study MVA and POC: Study (continued)(continued)

“…Significantly more re-aspirations for inability to accurately identify the pregnancy occurred in electric group.”

Goldberg AB et al. Obstet Gynecol, 2004

Goldberg AB, et al. Obstet Gynecol. 2004.

Early Abortion with MVA: Early Abortion with MVA: Study Study

MethodsMethods

2,399 MVA procedures, < 6 weeks LMP2,399 MVA procedures, < 6 weeks LMP

Meticulous inspection of POC immediately Meticulous inspection of POC immediately after MVAafter MVA

ResultsResults

99.2% effective in terminating pregnancy99.2% effective in terminating pregnancy

6 repeat aspirations (0.25%)6 repeat aspirations (0.25%)

14 ectopic pregnancies (0.6%) diagnosed 14 ectopic pregnancies (0.6%) diagnosed and treatedand treated

Edwards J, Creinin MD. Curr Probl OIbstet Gynecol Fertil. 1997.

Products of Conception (POC)Products of Conception (POC)

Edwards J, et al. Am J Obstet Gynecol. 1997.MacIsaac L, et al. Am J Obstet Gynecol. 2000.

Procedure is complete when POC are identifiedProcedure is complete when POC are identified

Electric Suction Machine

MVA Aspirator

Patient SatisfactionPatient Satisfaction Both EVA and MVA groups were highly satisfied Both EVA and MVA groups were highly satisfied No differences in:No differences in:

PainPain

AnxietyAnxiety

BleedingBleeding

Acceptability Acceptability

SatisfactionSatisfaction

More EVA patients were bothered by noiseMore EVA patients were bothered by noise

Bird ST, et al. Contraception. 2003.; Dean G, et al. Contraception. 2003.; Edelman A, et al. Am J Obstet Gynecol. 2001.

MVA Safety and Efficacy: MVA Safety and Efficacy: SummarySummary

MVA is simpleMVA is simple

Easily incorporated into office settingEasily incorporated into office setting

Training/Practice IssuesTraining/Practice Issues

Expanding pain management optionsExpanding pain management options

Ultrasound as neededUltrasound as needed

No sharp curettageNo sharp curettage

Patient-provider interactionPatient-provider interaction

Instrument processing for multiple use (new guidelines)Instrument processing for multiple use (new guidelines)

RebeccaRebecca

Rebecca is wanting to have an office Rebecca is wanting to have an office procedure, but she is concerned about the procedure, but she is concerned about the pain.pain.

What can you tell her about pain What can you tell her about pain management in the office?management in the office?

MVA and PainMVA and Pain

Pain is made worse by:Pain is made worse by:

FearfulnessFearfulness

AnxietyAnxiety

DepressionDepression

Belanger E, et al. Pain. 1989.; Smith GM, et al. Am J Obstet Gynecol. 1979.Hansen GR, Streltzer J. Emerg Med Clin N Am. 2005.

Effective Pain ManagementEffective Pain Management

Respectful, informed, and supportive Respectful, informed, and supportive staffstaff

Warm, friendly environmentWarm, friendly environment

Gentle operative techniqueGentle operative technique

Women’s involvementWomen’s involvement

Effective pain medicationsEffective pain medications

Pain Management TechniquesPain Management Techniques

Lichtengerg ES, et al. Contraception. 2001.Good M, et al. Pain Manag Nurs. 2002.

Local

General or nitrous

Local + IV

10%

32% 58%

With addition of:• Focused breathing: 76%• Visualization: 31%• Localized massage: 14%

Efficacy of Ancillary AnesthesiaEfficacy of Ancillary Anesthesia

Importance of psychological preparation Importance of psychological preparation and support and support

Music as analgesia for abortion patients Music as analgesia for abortion patients receiving paracervical block receiving paracervical block

85% who wore headphones rated 85% who wore headphones rated pain as “0,” compared with 52% pain as “0,” compared with 52% of controlsof controls

Verbicaine (“Vocal Local”)/Distraction Verbicaine (“Vocal Local”)/Distraction TherapyTherapy

Shapiro AG, Cohen H. Contraception. 1975. Stubblefield PG.Suppl Int J Gynecol Obstet. 1989.

Paracervical BlockParacervical Block

Regular InjectionDeep Injection

Castleman L, Mann C. 2002. Maltzer DS, et al. 1999.

Sharp Curettage and PainSharp Curettage and Pain

Often requires Often requires increased dilatation increased dilatation

Often painfulOften painful

More difficult to More difficult to reduce anesthesiareduce anesthesia

Forna F, Gulmezoglu AM. Cochrane Library. 2002.

Sharp Curettage and MVASharp Curettage and MVA

Generally not indicated Generally not indicated

Not routinely recommended after MVA Not routinely recommended after MVA

WHO. 2003

more…

Ultrasound and MVAUltrasound and MVA

Not required for Not required for MVAMVA

Used by some Used by some providers routinelyproviders routinely

Use contingent on Use contingent on provider preference provider preference and experienceand experience

Word Health Organization. 2003.

Counseling for MVACounseling for MVA

Effective counseling occurs Effective counseling occurs before, during, and after the before, during, and after the procedureprocedurePrepare women for Prepare women for procedure-related effectsprocedure-related effectsAddress women’s concerns Address women’s concerns about future desired about future desired pregnanciespregnancies

more…Breitbart V, Repass DC. J Am Med Womens Assoc. 2000.; Hogue CJ, et al. Epidemiol Rev. 1982; Steward FH, et al. 2004. Hyman AG, Castleman L. 2005

RebeccaRebecca

Rebecca is scheduled for a uterine aspiration Rebecca is scheduled for a uterine aspiration with MVA procedure during the next with MVA procedure during the next procedure clinic. procedure clinic.

The procedure is uncomplicated and her The procedure is uncomplicated and her questions include:questions include:

Can I get pregnant right away?Can I get pregnant right away?

Am I at risk for another miscarriage? Am I at risk for another miscarriage?

1 SAb 2 SAbs 3 SAbs0%

10%

20%

30%

40%

50%

Future Miscarriage RiskFuture Miscarriage Risk

20%20%28%28%

43%43%

Counseling for MVA Counseling for MVA (continued)(continued)

Picker Institute. 1999.

Quality of counseling

Patient satisfaction with care

Postmiscarriage CarePostmiscarriage CareManagement of Early Pregnancy LossManagement of Early Pregnancy Loss

Rhogam at time of diagnosis or surgeryRhogam at time of diagnosis or surgery Pelvic rest for 2 weeks Pelvic rest for 2 weeks No evidence for delaying conceptionNo evidence for delaying conception Initiate contraception upon completion Initiate contraception upon completion

of procedure (even IUDs!)of procedure (even IUDs!) Expect light-moderate bleeding for 2 weeks Expect light-moderate bleeding for 2 weeks Menses return after 6 weeksMenses return after 6 weeks Negative ßhCG values after 2–4 weeksNegative ßhCG values after 2–4 weeks Appropriate grief counselingAppropriate grief counseling

Goldstein R, Am J Obstet. Gynecol 2002; Wyss P, J Perinat Med 1994; Grimes D, Cochrane Database Syst Rev 2000

When Women Should Contact When Women Should Contact ClinicianClinician

Heavy bleeding with dizziness, Heavy bleeding with dizziness, lightheadednesslightheadedness

Worsening pain not relieved with medicationWorsening pain not relieved with medication

Flu-like symptoms lasting >24 hoursFlu-like symptoms lasting >24 hours

Fever or chillsFever or chills

SyncopeSyncope

Any questionsAny questions

For more information on EPLFor more information on EPL

Association of Reproductive Health Association of Reproductive Health Professionals (ARHP) archived webinar: Professionals (ARHP) archived webinar: Options for Early Pregnancy Loss: MVA and Options for Early Pregnancy Loss: MVA and Medication ManagementMedication Management

www.arhp.org/healthcareproviders/cme/webcme/index.cfm

Ipas WomanCare Kit for Miscarriage Ipas WomanCare Kit for Miscarriage ManagementManagement

www.ipaswomancare.comwww.ipaswomancare.com

?QuestionsQuestions

Papaya Demonstration to FollowPapaya Demonstration to Follow

pragers@u.washington.edupragers@u.washington.edu

Thanks!