Term Prelabour Rupture of Membranes (Term Prom) (C-Obs 36) Review Mar 14

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Term Prelabour Rupture of Membranes (Term PROM)

Objectives: To provide advice on the management of Term (37 weeks gestation) Prelabour Rupture of Membranes (Term PROM)

Options: Expectant management versus active management with induction of labour.

Outcomes: To improve maternal and fetal outcomes of those women undergoing Term Prelabour Rupture of Membranes (PROM)

Target audience: All health practitioners providing maternity care and patients.

Evidence: Medline was searched for randomised trials and cohort studies comparing expectant management versus active management with induction of labour.

Values: The evidence was reviewed by the Womens Health Committee (RANZCOG), and applied to local factors relating to Australia and New Zealand.

Validation: This statement was compared with RCOG and NICE guidelines on this topic. Funding: The development and review of this statement was funded by RANZCOG.

This statement has been developed and reviewed by the Womens Health Committee and approved by the RANZCOG Board and Council.

A list of Womens Health Committee Members can be found in Appendix A.

Disclosure statements have been received from all members of this committee.

Disclaimer This information is intended to provide general advice to practitioners. This information should not be relied on as a substitute for proper assessment with respect to the particular circumstances of each case and the needs of any patient. This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The document has been prepared having regard to general circumstances. First endorsed by RANZCOG: July 2010 Current: March 2014 Review due: March 2017

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Table of Contents

1. Patient Summary ....................................................................................................................... 3

2. Summary of recommendations ................................................................................................... 3

3. Introduction .............................................................................................................................. 4

4. Definition ................................................................................................................................. 4

5. Evidence summary and basis for recommendations ...................................................................... 4

4.1 What are the immediate risks of term PROM? ........................................................................... 4

4.2 What are the delayed risks of term PROM? ............................................................................... 4

4.3 What are the differences in outcome between expectant management and induction of labour? ... 4

4.4 How should women with term PROM be assessed? ................................................................... 5

4.5 How should women with term PROM be managed? .................................................................. 5

4.5.1 Active management.......................................................................................................... 5

4.5.2 Expectant management .................................................................................................... 5

4.5.3 What is the role of antibiotics in term PROM? ..................................................................... 6

4.5.4 Should women with term PROM be managed at home or in hospital? .................................. 6

4.5.5 Should induction of labour be undertaken with oxytocin or vaginal prostaglandins? ............... 7

6. Conclusion ............................................................................................................................... 7

7. References ................................................................................................................................ 8

8. Links to other College statements ............................................................................................... 9

9. Patient information .................................................................................................................... 9

Appendices ................................................................................................................................... 10

Appendix A Womens Health Committee Membership ................................................................... 10

Appendix B Overview of the development and review process for this statement ............................... 10

Appendix C Full Disclaimer ......................................................................................................... 12

Term Prelabour Rupture of Membranes (Term PROM) C-Obs 36

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1. Patient Summary In about one in 12 pregnancies, the bag of waters around the baby will break before labour begins. This most commonly happens at term (after 37 weeks). If a woman is known or suspected to have broken the waters in this situation, it is important that a careful assessment is made. Sometimes it is not clear that the waters have actually broken, and additional tests might have to be done to find the answer. If women are known to carry the group B streptococcus, they might be treated with antibiotics to help protect the baby, and labour might be induced. Medical studies suggest that using antibiotics for all women with broken waters at term decreases the risk of complications of infection. Ultimately, delivery of the baby is necessary, and if labour does not occur naturally it might be induced. Women who choose to stay at home to await the onset of labour after their waters break need to be carefully checked, to minimise that chance of complications.

2. Summary of recommendations

Recommendation 1 Grade and reference Initial assessment of women presenting with term PROM should include confirmation of the diagnosis, confirmation of gestation and presentation and assessment of maternal and fetal wellbeing. Where there is diagnostic uncertainty, a sterile speculum examination should be performed, and Ph based tests (e.g. Nitrazine) or those that test for placental alpha microglobulin-1 protein in vaginal fluid (e.g. Amniosure) may be used. Digital vaginal examination should be avoided unless immediate induction is planned as this has been shown to increase the rate of neonatal infection.

Consensus-based recommendation1

Recommendation 2 Grade and reference In women known to have vaginal Group B streptococcus (GBS) colonisation, use of prophylactic antibiotics and early induction of labour is recommended.

Consensus-based recommendation 2

Recommendation 3 Grade and reference Antibiotic use in term PROM appears to be associated with a reduced risk of maternal infectious morbidity.

Consensus-based recommendation 3, 4

Recommendation 4 Grade and reference Women with PROM at term should be informed of the risks and benefits of the options of active and expectant management.

Consensus-based recommendation

Recommendation 5 Grade and reference If after counselling regarding the risks and benefits of active verse expectant management women elect for expectant management of term PROM, and this is undertaken at home, women must be advised of the importance of surveillance for infection, live close to hospital, and have adequate support and means of transportation.


Recommendation 6 Grade and reference Induction of labour with oxytocin remains the method of choice for most RANZCOG Fellows, but in the sub set of women with an unfavourable cervix, prostaglandins may have an important role.



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3. Introduction The incidence of term PROM is 8%. Spontaneous labour follows term PROM at 24, 48 and 96 hours in 70%, 85% and 95% of women, respectively.6, 7 Thus, an important proportion of women have significant latency from PROM to delivery if managed expectantly, particularly nulliparous women. Management of term PROM requires a clear discussion with the woman, her partner and caregivers regarding the benefits and risks of expectant management versus active management with induction of labour.

4. Definition Term Prelabour Rupture of Membranes (term PROM) is defined as rupture of the membranes prior to the onset of labour at or beyond 37 weeks gestation.

5. Evidence summary and basis for recommendations

5.1 What are the immediate risks of term PROM? The immediate risks of rupture of membranes include cord prolapse, cord compression and placental abruption.

5.2 What are the delayed risks of term PROM? Delayed risks include maternal and neonatal infection. The quality of data with which to counsel women has been largely influenced by the 1996 randomised Term Prelabour Rupture of the Membranes (TERMPROM) study.7 The major comparisons between the induction with oxytocin group and the expectant management group (oxytocin) in this study are as follows:

Induction with oxytocin

Expectant Management Oxytocin

Caesarean section 127/1258 (10.1%) 123/1263 (9.7%) Neonatal infection 25/1258 (2%) 36/1263 (2.8%) Clinical chorioamnionitis * 50/1258 (4%) 109/1263 (8.6%) Intrapartum fever* 46/1258 (3.7%) 93/1263 (7.4%) Postpartum fever* 24/1258 (1.9%) 46/1253 (3.6%) Antibiotics before/during labour* 94/1258 (7.5%) 150/1263 (11.9%) Neonatal antibiotics* 94/1258 (7.5%) 172/1263 (13.7%) NICU stay* 83/1258 (6.6%) 146/1263 (11.6%) Median time to active labour 5 hours 17.3 hours *denotes outcomes with statistically significant differences

5.3 What are the differences in outcome between expectant management and induction of labour? The 2006 Cochrane review by Dare and colleagues has provided information regarding 6814 women in 12 trials with term PROM managed expectantly or with induction using prostaglandins or oxytocin.8 The findings did not differ greatly from TERMPROM study.7

No difference in caesarean section rate (RR 0.94, 95% CI 0.82-1.08). No difference in operative vaginal birth (RR 0.98, 95% CI 0.84-1.16). Active management associated with significant reduction in:

- chorioamnionitis (RR 0.74, 95% CI 0.56-0.97); - endometritis (RR 0.3, 95% CI 0.12-0.74).

No difference in neonatal infection (RR 0.83, 95% CI 0.69-1.12). Active management associated with significant reduction in NICU/SCN admission (RR 0.72, 95%

0.57-0.92), with NNT of 20. Significantly more women viewed their care more positively with active management (RR for

nothing liked 0.45, 95% CI 0.37-0.54).


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Neonatal infection is uncommon, and the lack of significance between expectant and active management in the randomised trials is likely to represent underpowering, given the other outcomes related to infection were all increased in the expectant management group. Neonatal infection can result in devastating sequelae including death, chronic lung disease and cerebral palsy. Several case control studies have strongly implicated chorioamnionitis as a cause of loss and cerebral palsy in term infants.9 Potentially serious maternal morbidity from chorioamnionitis or endometritis is also associated with increasing latency in term PROM. While active management of term PROM was initially thought to be associated with an increased risk of operative delivery and caesarean section, these concerns have not been borne out in randomised studies.

5.4 How should women with term PROM be assessed? Initial assessment of women presenting with term PROM should include confirmation of the diagnosis, gestational age, fetal presentation and assessment of maternal and fetal wellbeing. Nitrazine (pH based) tests or Amnisure (detecting placental alpha microglobulin-1 protein in vaginal fluid) may be used where there is diagnostic uncertainty. Digital vaginal examination should be avoided unless immediate induction is planned as this has been shown to increase the rate of neonatal infection.

5.5 How should women with term PROM be managed?

5.5.1 Active management Active management of term PROM with induction is associated with reduced maternal infective morbidity and increased maternal satisfaction without increasing caesarean section or operative vaginal birth. Fewer infants are admitted to NICU and fewer infants require postnatal antibiotics. Nevertheless, following preliminary assessment, some women and/ or clinicians may reasonably elect for a short trial of expectant management (e.g. for up to 24/24) in highly selected and well supervised cases.

5.5.2 Expectant management Criteria for expectant management includes:

Term PROM with fixed cephalic presentation. Group B streptococcus (GBS) negative. No signs infection (maternal tachycardia, fever, uterine tenderness). Normal CTG. No history of digital vaginal exam, cervical suture. Adequate resource/staffing to provide support as an outpatient or inpatient. Commitment to 4 hourly maternal temperature, evaluation of vaginal loss and assessment

of fetal well-being.

Recommendation 1 Grade and reference Initial assessment of women presenting with term PROM should include confirmation of the diagnosis, confirmation of gestation and presentation and assessment of maternal and fetal wellbeing. Nitrazine (pH based) tests or Amnisure (detecting placental alpha microglobulin-1 protein in vaginal fluid) may be used where there is diagnostic uncertainty.1 Digital vaginal examination should be avoided unless immediate induction is planned as this has been shown to increase the rate of neonatal infection.



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5.5.3 What is the role of antibiotics in term PROM? a) Women who are known to be GBS positive

In women known to have vaginal Group B streptococcus (GBS) colonisation, prophylactic antibiotics and early administration of oxytocin is recommended. See College Statement (C-Obs 19) Screening and Treatment for Group B Streptococcus in Pregnancy for further detail.

b) Women known to be GBS negative Available evidence comes from a Cochrane review involving 838 women, and a recent trial of 161 women.3, 4 Collectively, these studies suggest that the use of antibiotics reduces the risk of maternal infectious morbidity (chorioamnionitis and endometritis), with the Cochrane review reporting RR of 0.43 (95% CI 0.23-0.82) for maternal infectious morbidity, and NNT 25. The trial of Passos et al. was confined to women known to be GBS negative and still found lower rates of infection among women receiving intravenous ampicilinn and gentamicin (2.6% compared to 13.2%; RR 0.89 (0.81-0.98), although the risks of this approach need to be considered given the recently highlighted risks of vestibulotoxicity10 particularly with repeated or prolonged gentamicin dosing. The study of Passos also confirmed that all cases of maternal infection occurred in women with ROM for >12 hours, underscoring the importance of timely induction in reducing infectious morbidity. Whilst neither of these studies reported a statistically significant difference in neonatal morbidity, these trials are under-powered to assess this outcome.

5.5.4 Should women with term PROM be managed at home or in hospital? A sub-analysis of term PROM concluded that expectant management at home was associated with a further increase in the risk of maternal need for antibiotics (OR 1.52) and neonatal infection (OR 1.97).11 In preterm PROM, women managed as an outpatient face additional risks associated with rapid delivery.12 Women being managed expectantly at home must therefore be carefully selected to ensure that they not only meet the criteria in 4.5.2, but also live close to the hospital, have adequate support at home and dependable transport.

Recommendation 2 Grade and reference

In women known to have vaginal Group B streptococcus (GBS) colonisation, prophylactic antibiotics and early induction of labour is recommended.


Recommendation 3 Grade and reference

Antibiotic use in term PROM appears to be associated with a reduced risk of maternal infectious morbidity.

Consensus-based recommendation 3, 4


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5.5.5 Should induction of labour be undertaken with oxytocin or vaginal prostaglandins? The available evidence on prostaglandins (Prostin, Cervidil or misoprostol) versus oxytocin for induction following term PROM is limited, and has failed to show a clear benefit. The previous Cochrane meta -analysis, suggested an increased risk of chorioamnionitis and neonatal infection with administration of prostaglandins.13 Concerns regarding the risk of hyperstimuation and tachysystole may be part of the reason that drug information on commonly used prostaglandin preparations (Prostin and Cervidil) lists ruptured membranes as a contraindication to use. This complication was not reported more frequently in the meta-analysis examining misoprostol use for induction with term PROM, but doses greater than 25 g have been associated with increased risks of hyperstimulation and should be avoided.14

For these reasons, oxytocin remains the method of choice for most RANZCOG fellows,5 but in the sub set of women with an unfavourable cervix, prostaglandins may have an important role. This has been evaluated in one small trial where dinoprostone followed by oxytocin 6 hours later in women with a Bishop score of

7. References 1. Neil PR, Wallace EM. Is Amnisure(R) useful in the management of women with prelabour rupture of

the membranes? Aust N Z J Obstet Gynaecol. 2010;50(6):534-8. 2. Prevention of Perinatal Group B Streptococcal Disease Revised Guidelines from CDC, 2010

Continuing Education. Centers for Disease Control and Prevention. MMWR 2010;59 3. Flenady V, King J. Antibiotics for prelabour rupture of membranes at or near term. Cochrane

Database Syst Rev. 2002(3):CD001807. 4. Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis

in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012;120(5):1045-51.

5. Weekes CR, Mahomed K. Management of pre-labour rupture of membranes at term - a survey of current practice in Australia. Aust N Z J Obstet Gynaecol. 2010;50(5):428-31.

6. Keirse MJ, Ottervanger HP, Smit W. Controversies: prelabor rupture of the membranes at term: the case for expectant management. J Perinat Med. 1996;24(6):563-72.

7. Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, et al. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996;334(16):1005-10.

8. Dare MR, Middleton P, Crowther CA, Flenady VJ, Varatharaju B. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2006(1):CD005302.

9. Wu YW, Escobar GJ, Grether JK, Croen LA, Greene JD, Newman TB. Chorioamnionitis and cerebral palsy in term and near-term infants. JAMA. 2003;290(20):2677-84.

10. Ahmed RM, Hannigan IP, MacDougall HG, Chan RC, Halmagyi GM. Gentamicin ototoxicity: a 23-year selected case series of 103 patients. MJA. 2012;196(11):701-4.

11. Hannah ME, Hodnett ED, Willan A, Foster GA, Di Cecco R, Helewa M. Prelabor rupture of the membranes at term: expectant management at home or in hospital? The TermPROM Study Group. Obstet Gynecol. 2000;96(4):533-8.

12. Ellestad SC, Swamy GK, Sinclair T, James AH, Heine RP, Murtha AP. Preterm premature rupture of membrane management--inpatient versus outpatient: a retrospective review. Am J Perinatol. 2008;25(1):69-73.

13. Tan BP, Hannah ME. Prostaglandins versus oxytocin for prelabour rupture of membranes at term. Cochrane Database Syst Rev. 2000(2):CD000159.

14. Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005;106(3):593-601.

15. Gungorduk K, Asicioglu O, Besimoglu B, Gungorduk OC, Yildirm G, Ark C, et al. Labor induction in term premature rupture of membranes: comparison between oxytocin and dinoprostone followed 6 hours later by oxytocin. Am J Obstet Gynecol. 2012;206(1):60 e1-8.

16. National Health and Medical Research Council. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. Canberra; 2009.


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8. Links to other College statements (C-Obs 31) Routine Intrapartum Care in the absence of Pregnancy Complications http://www.ranzcog.edu.au/component/docman/doc_download/964-c-obs-31-routine-intrapartum-care-in-the-absence-of-pregnancy-complications-.html

(C-Obs 17) Intrapartum Fetal Surveillance Clinical Guidelines - Second Edition http://www.ranzcog.edu.au/component/docman/doc_download/951-c-obs-17-intrapartum-fetal-surveillance-clinical-guidelines-second-edition.html

(C-Obs 19) Screening and Treatment for Group B Streptococcus in Pregnancy http://www.ranzcog.edu.au/component/docman/doc_download/953-c-obs-19-screening-and-treatment-for-group-b-streptococcus-in-pregnancy.html

(C-Gen 15) Evidence-based Medicine, Obstetrics and Gynaecology http://www.ranzcog.edu.au/component/docman/doc_download/894-c-gen-15-evidence-based-medicine-obstetrics-and-gynaecology.html?Itemid=341

9. Patient information A range of RANZCOG Patient Information Pamphlets can be ordered via:

http://www.ranzcog.edu.au/publication/womens-health-publications/patient-information pamphlets.html


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Appendices

Appendix A Womens Health Committee Membership

Appendix B Overview of the development and review process for this statement i. Steps in developing and updating this statement

This statement was originally developed in July 2010 and was most recently reviewed in March 2014. The Womens Health Committee carried out the following steps in reviewing this statement:

Declarations of interest were sought from all members prior to reviewing this statement.

Structured clinical questions were developed and agreed upon.

An updated literature search to answer the clinical questions was undertaken.

At the March 2014 face-to-face committee meeting, the existing consensus-based recommendations were reviewed and updated (where appropriate) based on the available body of evidence and clinical expertise. Recommendations were graded as set out below in Appendix A part iii)

ii. Declaration of interest process and management

Declaring interests is essential in order to prevent any potential conflict between the private interests of members, and their duties as part of the Womens Health Committee.

A declaration of interest form specific to guidelines and statements was developed by RANZCOG and approved by the RANZCOG Board in September 2012. The Womens Health Committee members

Name Position on Committee Associate Professor Stephen Robson Chair Professor Susan Walker Deputy Chair - Obstetrics Dr Gino Pecoraro Deputy Chair - Gynaecology Professor Yee Leung Member Associate Professor Anuschirawan Yazdani Member Dr Simon Craig Member Associate Professor Paul Duggan Member Dr Vijay Roach Member Dr Stephen Lyons Member Dr Ian Page Member Dr Donald Clark Member Dr Amber Moore Member Dr Martin Ritossa Member Dr Benjamin Bopp Member Dr James Harvey Member Dr John Tait Member Dr Anthony Frumar Member Associate Professor Kirsten Black Member Dr Jacqueline Boyle

Chair of IWHC Dr Louise Sterling GPOAC representative Ms Catherine Whitby Council Consumer representative Ms Susan Hughes Consumer representative Ms Sherryn Elworthy Midwifery representative Dr Scott White Trainee representative Dr Agnes Wilson RANZCOG Guideline developer


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were required to declare their relevant interests in writing on this form prior to participating in the review of this statement.

Members were required to update their information as soon as they become aware of any changes to their interests and there was also a standing agenda item at each meeting where declarations of interest were called for and recorded as part of the meeting minutes.

There were no significant real or perceived conflicts of interest that required management during the process of updating this statement.

iii. Grading of recommendations

Each recommendation in this College statement is given an overall grade as per the table below, based on the National Health and Medical Research Council (NHMRC) Levels of Evidence and Grades of Recommendations for Developers of Guidelines.16 Where no robust evidence was available but there was sufficient consensus within the Womens Health Committee, consensus-based recommendations were developed or existing ones updated and are identifiable as such. Consensus-based recommendations were agreed to by the entire committee. Good Practice Notes are highlighted throughout and provide practical guidance to facilitate implementation. These were also developed through consensus of the entire committee.

Recommendation category Description

Evidence-based A Body of evidence can be trusted to guide practice

B Body of evidence can be trusted to guide practice in most situations

C Body of evidence provides some support for recommendation(s) but care should be taken in its application

D The body of evidence is weak and the recommendation must be applied with caution

Consensus-based Recommendation based on clinical opinion and expertise as insufficient evidence available

Good Practice Note Practical advice and information based on clinical opinion and expertise


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Appendix C Full Disclaimer This information is intended to provide general advice to practitioners, and should not be relied on as a substitute for proper assessment with respect to the particular circumstances of each case and the needs of any patient.

This information has been prepared having regard to general circumstances. It is the responsibility of each practitioner to have regard to the particular circumstances of each case. Clinical management should be responsive to the needs of the individual patient and the particular circumstances of each case.

This information has been prepared having regard to the information available at the time of its preparation, and each practitioner should have regard to relevant information, research or material which may have been published or become available subsequently.

Whilst the College endeavours to ensure that information is accurate and current at the time of preparation, it takes no responsibility for matters arising from changed circumstances or information or material that may have become subsequently available.


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1. Patient Summary2. Summary of recommendations3. Introduction4. Definition5. Evidence summary and basis for recommendations5.1 What are the immediate risks of term PROM?5.2 What are the delayed risks of term PROM?5.3 What are the differences in outcome between expectant management and induction of labour?5.4 How should women with term PROM be assessed?5.5 How should women with term PROM be managed?5.5.1 Active management5.5.2 Expectant management5.5.3 What is the role of antibiotics in term PROM?5.5.4 Should women with term PROM be managed at home or in hospital?5.5.5 Should induction of labour be undertaken with oxytocin or vaginal prostaglandins?

6. Conclusion7. References8. Links to other College statements9. Patient informationAppendicesAppendix A Womens Health Committee MembershipAppendix B Overview of the development and review process for this statementAppendix C Full Disclaimer

Term Prelabour Rupture of Membranes (Term Prom) (C-Obs 36) Review Mar 14

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