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Meta-Analysis
. 2017 Jan 4;1(1):CD005302.
doi: 10.1002/14651858.CD005302.pub3.

Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more)

Philippa Middleton  1 , Emily Shepherd  2 , Vicki Flenady  3 , Rosemary D McBain  2 , Caroline A Crowther  4
Affiliations
Meta-Analysis

Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more)

Philippa Middleton et al. Cochrane Database Syst Rev. .

Abstract

Background: Prelabour rupture of membranes (PROM) at term is managed expectantly or by planned early birth. It is not clear if waiting for birth to occur spontaneously is better than intervening, e.g. by inducing labour.

Objectives: The objective of this review is to assess the effects of planned early birth (immediate intervention or intervention within 24 hours) when compared with expectant management (no planned intervention within 24 hours) for women with term PROM on maternal, fetal and neonatal outcomes.

Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register (9 September 2016) and reference lists of retrieved studies.

Selection criteria: Randomised or quasi-randomised controlled trials of planned early birth compared with expectant management (either in hospital or at home) in women with PROM at 37 weeks' gestation or later.

Data collection and analysis: Two review authors independently assessed trials for inclusion, extracted the data, and assessed risk of bias of the included studies. Data were checked for accuracy.

Main results: Twenty-three trials involving 8615 women and their babies were included in the update of this review. Ten trials assessed intravenous oxytocin; 12 trials assessed prostaglandins (six trials in the form of vaginal prostaglandin E2 and six as oral, sublingual or vaginal misoprostol); and one trial each assessed Caulophyllum and acupuncture. Overall, three trials were judged to be at low risk of bias, while the other 20 were at unclear or high risk of bias.Primary outcomes: women who had planned early birth were at a reduced risk of maternal infectious morbidity (chorioamnionitis and/or endometritis) than women who had expectant management following term prelabour rupture of membranes (average risk ratio (RR) 0.49; 95% confidence interval (CI) 0.33 to 0.72; eight trials, 6864 women; Tau² = 0.19; I² = 72%; low-quality evidence), and their neonates were less likely to have definite or probable early-onset neonatal sepsis (RR 0.73; 95% CI 0.58 to 0.92; 16 trials, 7314 infants;low-quality evidence). No clear differences between the planned early birth and expectant management groups were seen for the risk of caesarean section (average RR 0.84; 95% CI 0.69 to 1.04; 23 trials, 8576 women; Tau² = 0.10; I² = 55%; low-quality evidence); serious maternal morbidity or mortality (no events; three trials; 425 women; very low-quality evidence); definite early-onset neonatal sepsis (RR 0.57; 95% CI 0.24 to 1.33; six trials, 1303 infants; very low-quality evidence); or perinatal mortality (RR 0.47; 95% CI 0.13 to 1.66; eight trials, 6392 infants; moderate-quality evidence).

Secondary outcomes: women who had a planned early birth were at a reduced risk of chorioamnionitis (average RR 0.55; 95% CI 0.37 to 0.82; eight trials, 6874 women; Tau² = 0.19; I² = 73%), and postpartum septicaemia (RR 0.26; 95% CI 0.07 to 0.96; three trials, 263 women), and their neonates were less likely to receive antibiotics (average RR 0.61; 95% CI 0.44 to 0.84; 10 trials, 6427 infants; Tau² = 0.06; I² = 32%). Women in the planned early birth group were more likely to have their labour induced (average RR 3.41; 95% CI 2.87 to 4.06; 12 trials, 6945 women; Tau² = 0.05; I² = 71%), had a shorter time from rupture of membranes to birth (mean difference (MD) -10.10 hours; 95% CI -12.15 to -8.06; nine trials, 1484 women; Tau² = 5.81; I² = 60%), and their neonates had lower birthweights (MD -79.25 g; 95% CI -124.96 to -33.55; five trials, 1043 infants). Women who had a planned early birth had a shorter length of hospitalisation (MD -0.79 days; 95% CI -1.20 to -0.38; two trials, 748 women; Tau² = 0.05; I² = 59%), and their neonates were less likely to be admitted to the neonatal special or intensive care unit (RR 0.75; 95% CI 0.66 to 0.85; eight trials, 6179 infants), and had a shorter duration of hospital (-11.00 hours; 95% CI -21.96 to -0.04; one trial, 182 infants) or special or intensive care unit stay (RR 0.72; 95% CI 0.61 to 0.85; four trials, 5691 infants). Women in the planned early birth group had more positive experiences compared with women in the expectant management group.No clear differences between groups were observed for endometritis; postpartum pyrexia; postpartum antibiotic usage; caesarean for fetal distress; operative vaginal birth; uterine rupture; epidural analgesia; postpartum haemorrhage; adverse effects; cord prolapse; stillbirth; neonatal mortality; pneumonia; Apgar score less than seven at five minutes; use of mechanical ventilation; or abnormality on cerebral ultrasound (no events).None of the trials reported on breastfeeding; postnatal depression; gestational age at birth; meningitis; respiratory distress syndrome; necrotising enterocolitis; neonatal encephalopathy; or disability at childhood follow-up.In subgroup analyses, there were no clear patterns of differential effects for method of induction, parity, use of maternal antibiotic prophylaxis, or digital vaginal examination. Results of the sensitivity analyses based on trial quality were consistent with those of the main analysis, except for definite or probable early-onset neonatal sepsis where no clear difference was observed.

Authors' conclusions: There is low quality evidence to suggest that planned early birth (with induction methods such as oxytocin or prostaglandins) reduces the risk of maternal infectious morbidity compared with expectant management for PROM at 37 weeks' gestation or later, without an apparent increased risk of caesarean section. Evidence was mainly downgraded due to the majority of studies contributing data having some serious design limitations, and for most outcomes estimates were imprecise.Although the 23 included trials in this review involved a large number of women and babies, the quality of the trials and evidence was not high overall, and there was limited reporting for a number of important outcomes. Thus further evidence assessing the benefits or harms of planned early birth compared with expectant management, considering maternal, fetal, neonatal and longer-term childhood outcomes, and the use of health services, would be valuable. Any future trials should be adequately designed and powered to evaluate the effects on short- and long-term outcomes. Standardisation of outcomes and their definitions, including for the assessment of maternal and neonatal infection, would be beneficial.

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Conflict of interest statement

Philippa Middleton: none known.

Emily Shepherd: none known.

Vicki Flenady: none known.

Rosemary D McBain: none known.

Caroline A Crowther: none known.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
4
4
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.7 Maternal infectious morbidity (chorioamnionitis, endometritis and/or pyrexia).
5
5
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.3 Caesarean section.
6
6
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.6 Definite or probable early‐onset neonatal sepsis.
7
7
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.9 Chorioamnionitis and/or pyrexia (either suspected or proven).
8
8
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.14 Caesarean section for fetal distress.
9
9
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.15 Induction of labour.
10
10
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.16 Operative vaginal birth.
11
11
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.23 Time from rupture of membranes to birth (hours).
12
12
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.31 Antibiotic usage.
13
13
Funnel plot of comparison: 1 Planned early birth versus expectant management (subgroups: method of induction), outcome: 1.32 Apgar score less than seven at five minutes.
1.1
1.1. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 1 Maternal infectious morbidity (chorioamnionitis and/or endometritis).
1.2
1.2. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 2 Perinatal mortality (stillbirth or neonatal mortality).
1.3
1.3. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 3 Caesarean section.
1.4
1.4. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 4 Serious maternal morbidity or mortality (e.g. death, cardiac arrest, respiratory arrest, admission to intensive care unit).
1.5
1.5. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 5 Definite early‐onset neonatal sepsis.
1.6
1.6. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 6 Definite or probable early‐onset neonatal sepsis.
1.7
1.7. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 7 Maternal infectious morbidity (chorioamnionitis, endometritis and/or pyrexia).
1.8
1.8. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 8 Chorioamnionitis (either suspected or proven).
1.9
1.9. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 9 Chorioamnionitis and/or pyrexia (either suspected or proven).
1.10
1.10. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 10 Endometritis.
1.11
1.11. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 11 Postpartum pyrexia.
1.12
1.12. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 12 Postpartum septicaemia.
1.13
1.13. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 13 Postpartum antibiotic usage.
1.14
1.14. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 14 Caesarean section for fetal distress.
1.15
1.15. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 15 Induction of labour.
1.16
1.16. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 16 Operative vaginal birth.
1.17
1.17. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 17 Uterine rupture.
1.18
1.18. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 18 Epidural analgesia.
1.19
1.19. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 19 Postpartum haemorrhage.
1.20
1.20. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 20 Views of care (VAS 100).
1.21
1.21. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 21 Views of care.
1.22
1.22. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 22 Views of care.
1.23
1.23. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 23 Time from rupture of membranes to birth (hours).
1.25
1.25. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 25 Birthweight (g).
1.27
1.27. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 27 Cord prolapse.
1.28
1.28. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 28 Stillbirth.
1.29
1.29. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 29 Neonatal mortality.
1.30
1.30. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 30 Pneumonia.
1.31
1.31. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 31 Antibiotic usage.
1.32
1.32. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 32 Apgar score less than seven at five minutes.
1.33
1.33. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 33 Use of mechanical ventilation.
1.34
1.34. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 34 Abnormality on cerebral ultrasound (cystic periventricular leukomalacia; intraventricular haemorrhage);.
1.35
1.35. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 35 Duration of maternal antenatal or postnatal stay in hospital (days).
1.37
1.37. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 37 Admission to neonatal special or intensive care unit.
1.38
1.38. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 38 Duration of neonatal stay in hospital (hours).
1.39
1.39. Analysis
Comparison 1 Planned early birth versus expectant management (subgroups: method of induction), Outcome 39 Neonatal stay in special or intensive care unit.
2.1
2.1. Analysis
Comparison 2 Planned early birth versus expectant management (subgroups: parity), Outcome 1 Maternal infectious morbidity (chorioamnionitis and/or endometritis).
2.2
2.2. Analysis
Comparison 2 Planned early birth versus expectant management (subgroups: parity), Outcome 2 Caesarean section.
2.3
2.3. Analysis
Comparison 2 Planned early birth versus expectant management (subgroups: parity), Outcome 3 Definite early‐onset neonatal sepsis.
2.4
2.4. Analysis
Comparison 2 Planned early birth versus expectant management (subgroups: parity), Outcome 4 Definite or probable early‐onset neonatal sepsis.
2.5
2.5. Analysis
Comparison 2 Planned early birth versus expectant management (subgroups: parity), Outcome 5 Perinatal mortality (stillbirth or neonatal mortality).
3.1
3.1. Analysis
Comparison 3 Planned early birth versus expectant management (subgroups: cervical status), Outcome 1 Maternal infectious morbidity (chorioamnionitis and/or endometritis).
3.2
3.2. Analysis
Comparison 3 Planned early birth versus expectant management (subgroups: cervical status), Outcome 2 Caesarean section.
3.3
3.3. Analysis
Comparison 3 Planned early birth versus expectant management (subgroups: cervical status), Outcome 3 Definite early‐onset neonatal sepsis.
3.4
3.4. Analysis
Comparison 3 Planned early birth versus expectant management (subgroups: cervical status), Outcome 4 Definite or probable early‐onset neonatal sepsis.
3.5
3.5. Analysis
Comparison 3 Planned early birth versus expectant management (subgroups: cervical status), Outcome 5 Perinatal mortality (stillbirth or neonatal mortality).
4.1
4.1. Analysis
Comparison 4 Planned early birth versus expectant management (subgroups: antibiotic prophylaxis), Outcome 1 Maternal infectious morbidity (chorioamnionitis and/or endometritis).
4.2
4.2. Analysis
Comparison 4 Planned early birth versus expectant management (subgroups: antibiotic prophylaxis), Outcome 2 Caesarean section.
4.3
4.3. Analysis
Comparison 4 Planned early birth versus expectant management (subgroups: antibiotic prophylaxis), Outcome 3 Definite early‐onset neonatal sepsis.
4.4
4.4. Analysis
Comparison 4 Planned early birth versus expectant management (subgroups: antibiotic prophylaxis), Outcome 4 Definite or probable early‐onset neonatal sepsis.
4.5
4.5. Analysis
Comparison 4 Planned early birth versus expectant management (subgroups: antibiotic prophylaxis), Outcome 5 Perinatal mortality (stillbirth or neonatal mortality).
5.1
5.1. Analysis
Comparison 5 Planned early birth versus expectant management (subgroups: digital vaginal examination), Outcome 1 Maternal infectious morbidity (chorioamnionitis and/or endometritis).
5.2
5.2. Analysis
Comparison 5 Planned early birth versus expectant management (subgroups: digital vaginal examination), Outcome 2 Caesarean section.
5.3
5.3. Analysis
Comparison 5 Planned early birth versus expectant management (subgroups: digital vaginal examination), Outcome 3 Definite early‐onset neonatal sepsis.
5.4
5.4. Analysis
Comparison 5 Planned early birth versus expectant management (subgroups: digital vaginal examination), Outcome 4 Definite or probable early‐onset neonatal sepsis.
5.5
5.5. Analysis
Comparison 5 Planned early birth versus expectant management (subgroups: digital vaginal examination), Outcome 5 Perinatal mortality (stillbirth or neonatal mortality).
6.1
6.1. Analysis
Comparison 6 Planned early birth versus expectant management (sensitivity analysis based on trial quality), Outcome 1 Maternal infectious morbidity (chorioamnionitis and/or endometritis).
6.2
6.2. Analysis
Comparison 6 Planned early birth versus expectant management (sensitivity analysis based on trial quality), Outcome 2 Caesarean section.
6.3
6.3. Analysis
Comparison 6 Planned early birth versus expectant management (sensitivity analysis based on trial quality), Outcome 3 Definite early‐onset neonatal sepsis.
6.4
6.4. Analysis
Comparison 6 Planned early birth versus expectant management (sensitivity analysis based on trial quality), Outcome 4 Definite or probable early‐onset neonatal sepsis.
6.5
6.5. Analysis
Comparison 6 Planned early birth versus expectant management (sensitivity analysis based on trial quality), Outcome 5 Perinatal mortality (stillbirth or neonatal mortality).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Akyol 1999 {published data only}
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Ayaz 2008 {published data only}
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Beer 1999 {published data only}
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Cheung 2006 {published data only}
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Chung 1992 {published data only}
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Fatima 2015 {published data only}
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Hannah 1996 {published data only}
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    1. Gafni A, Goeree R, Myhr TL, Hannah ME, Blackhouse G, Willan A, et al. Induction of labour versus expectant management for prelabour rupture of the membranes at term: an economic evaluation. Canadian Medical Association Journal 1997;157(11):1519‐25. - PMC - PubMed
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    1. Hannah M, Ohlsson A, Farine D, Hewson S, Hodnett E, Myhr T, et al. Vaginal prostaglandin E2 gel vs. intravenous oxytocin vs. expectant management for prelabour rupture of membranes at term: a randomised clinical trial. Proceedings of the 15th Conference of Priorities in Perinatal Care; 1996; South Africa. 1996:14.
    1. Hannah M, Ohlsson A, Wang E, Myhr T, Farine D, Hewson S, et al. Inducing labor with iv oxytocin may reduce the risk of neonatal infection in GBS positive women with PROM at term. American Journal of Obstetrics and Gynecology 1997;176(1 Pt 2):S32.
Javaid 2008 {published data only}
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Krupa 2005 {published data only}
    1. Krupa FG, Cecatti JG, Surita GC, Milanez HMBP, Parpinelli MA. Misoprostol versus expectant management in premature rupture of membranes at term. BJOG: an international journal of obstetrics and gynaecology 2005;112:1284‐90. - PubMed
Mahmood 1992 {published data only}
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Mahmood 1995 {published data only}
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Maqbool 2014 {published data only}
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McQueen 1992 {unpublished data only}
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Milasinovic 1998 {published and unpublished data}
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Natale 1994 {published data only}
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Ottervanger 1996 {published data only}
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Selmer‐Olsen 2007 {published data only}
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Shah 2012 {published data only}
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Shalev 1995 {published data only}
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References to studies excluded from this review

Alcalay 1996 {published data only}
    1. Alcalay M, Hourvitz A, Reichman B, Luski A, Quint J, Barkai G, et al. Prelabour rupture of membranes at term: early induction of labour versus expectant management. European Journal of Obstetrics & Gynecology and Reproductive Biology 1996;70:129‐33. - PubMed
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Brosnan 1996 {published data only}
    1. Brosnan C. Trial of active vs conservative approach to induction of labour in patients with prelabour rupture of the membranes at term on serious fetal/neonatal infection. Personal communication 1996.
Cararach 1996 {published data only}
    1. Cararach V, Sentis J, Botet F, Foradada C, Manau D, Figueras F, et al. Cervical prostaglandin E1 compared with expectant management and with systematic induction in PROM near term, with bad cervical conditions. I‐maternal results. 3rd World Congress of Perinatal Medicine; 1996 Oct 20‐24; San Francisco, USA. 1996:44.
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Chang 1997 {published data only}
    1. Chang P, Langer O. Premature rupture of membranes at term; a randomized controlled trial. American Journal of Obstetrics and Gynecology 1997;176(1 Pt 2):S148.
Chaudhuri 2006 {published data only}
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Chua 1995 {published data only}
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References to ongoing studies

Walfisch 2014 {published data only}
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References to other published versions of this review

Dare 2005
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