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Review
. 2017 Mar 3;3(3):CD004735.
doi: 10.1002/14651858.CD004735.pub4.

Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome

Affiliations
Review

Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome

Diana M Bond et al. Cochrane Database Syst Rev. .

Abstract

Background: Current management of preterm prelabour rupture of the membranes (PPROM) involves either initiating birth soon after PPROM or, alternatively, adopting a 'wait and see' approach (expectant management). It is unclear which strategy is most beneficial for mothers and their babies. This is an update of a Cochrane review published in 2010 (Buchanan 2010).

Objectives: To assess the effect of planned early birth versus expectant management for women with preterm prelabour rupture of the membranes between 24 and 37 weeks' gestation for fetal, infant and maternal well being.

Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register (30 September 2016), and reference lists of retrieved studies.

Selection criteria: Randomised controlled trials comparing planned early birth with expectant management for women with PPROM prior to 37 weeks' gestation. We excluded quasi-randomised trials.

Data collection and analysis: Two review authors independently evaluated trials for inclusion into the review and for methodological quality. Two review authors independently extracted data. We checked data for accuracy. We assessed the quality of evidence using the GRADE approach.

Main results: We included 12 trials in the review (3617 women and 3628 babies). For primary outcomes, we identified no clear differences between early birth and expectant management in neonatal sepsis (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.66 to 1.30, 12 trials, 3628 babies, evidence graded moderate), or proven neonatal infection with positive blood culture (RR 1.24, 95% CI 0.70 to 2.21, seven trials, 2925 babies). However, early birth increased the incidence of respiratory distress syndrome (RDS) (RR 1.26, 95% CI 1.05 to 1.53, 12 trials, 3622 babies, evidence graded high). Early birth was also associated with an increased rate of caesarean section (RR 1.26, 95% CI 1.11 to 1.44, 12 trials, 3620 women, evidence graded high).Assessment of secondary perinatal outcomes showed no clear differences in overall perinatal mortality (RR 1.76, 95% CI 0.89 to 3.50, 11 trials, 3319 babies), or intrauterine deaths (RR 0.45, 95% CI 0.13 to 1.57, 11 trials, 3321 babies) when comparing early birth with expectant management. However, early birth was associated with a higher rate of neonatal death (RR 2.55, 95% CI 1.17 to 5.56, 11 trials, 3316 babies) and need for ventilation (RR 1.27, 95% CI 1.02 to 1.58, seven trials, 2895 babies, evidence graded high). Babies of women randomised to early birth were delivered at a gestational age lower than those randomised to expectant management (mean difference (MD) -0.48 weeks, 95% CI -0.57 to -0.39, eight trials, 3139 babies). Admission to neonatal intensive care was more likely for those babies randomised to early birth (RR 1.16, 95% CI 1.08 to 1.24, four trials, 2691 babies, evidence graded moderate).In assessing secondary maternal outcomes, we found that early birth was associated with a decreased rate of chorioamnionitis (RR 0.50, 95% CI 0.26 to 0.95, eight trials, 1358 women, evidence graded moderate), and an increased rate of endometritis (RR 1.61, 95% CI 1.00 to 2.59, seven trials, 2980 women). As expected due to the intervention, women randomised to early birth had a higher chance of having an induction of labour (RR 2.18, 95% CI 2.01 to 2.36, four trials, 2691 women). Women randomised to early birth had a decreased total length of hospitalisation (MD -1.75 days, 95% CI -2.45 to -1.05, six trials, 2848 women, evidence graded moderate).Subgroup analyses indicated improved maternal and infant outcomes in expectant management in pregnancies greater than 34 weeks' gestation, specifically relating to RDS and maternal infections. The use of prophylactic antibiotics were shown to be effective in reducing maternal infections in women randomised to expectant management.Overall, we assessed all 12 studies as being at low or unclear risk of bias. Some studies lacked an adequate description of methods and the risk of bias could only be assessed as unclear. In five of the studies there were one and/or two domains where the risk of bias was judged as high. GRADE profiling showed the quality of evidence across all critical outcomes to be moderate to high.

Authors' conclusions: With the addition of five randomised controlled trials (2927 women) to this updated review, we found no clinically important difference in the incidence of neonatal sepsis between women who birth immediately and those managed expectantly in PPROM prior to 37 weeks' gestation. Early planned birth was associated with an increase in the incidence of neonatal RDS, need for ventilation, neonatal mortality, endometritis, admission to neonatal intensive care, and the likelihood of birth by caesarean section, but a decreased incidence of chorioamnionitis. Women randomised to early birth also had an increased risk of labour induction, but a decreased length of hospital stay. Babies of women randomised to early birth were more likely to be born at a lower gestational age.In women with PPROM before 37 weeks' gestation with no contraindications to continuing the pregnancy, a policy of expectant management with careful monitoring was associated with better outcomes for the mother and baby.The direction of future research should be aimed at determining which groups of women with PPROM would not benefit from expectant management. This could be determined by analysing subgroups according to gestational age at presentation, corticosteroid usage, and abnormal vaginal microbiological colonisation. Research should also evaluate long-term neurodevelopmental outcomes of infants.

PubMed Disclaimer

Conflict of interest statement

Diana M Bond: I was employed as the Multi‐Center Trial Co‐ordinator for the NHMRC funded PPROMT trial which is included in this review. The NHMRC has had no input or influence regarding the publication of this review.

Philippa Middleton: none known.

Kate M Levett: acted as a trial co‐ordinator for the NHMRC (National Health and Medical Research Council) funded PPROMT trial, one of the included trials.

David P van der Ham: was Chief Investigator and first author of the PPROMEXIL trials. Jonathan Morris and Diana Bond were responsible for data extraction and assessment of all these trial reports.

Caroline A Crowther: was involved in the planning of the PPROMPT trial.

Sarah L Buchanan: was involved in the planning of the PPROMPT trial.

Jonathan Morris: was the Chief Investigator and first author for the NHMRC‐ (National Health and Medical Research Council) funded PPROMT trial.

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 Any planned birth versus expectant management: by type, outcome: 1.1 Neonatal infection/sepsis
5
5
Funnel plot of comparison: 1 Any planned birth versus expectant management: by type, outcome: 1.3 Respiratory distress syndrome
6
6
Funnel plot of comparison: 1 Any planned birth versus expectant management: by type, outcome: 1.4 Caesarean section
7
7
Funnel plot of comparison: 1 Any planned birth versus expectant management: by type, outcome: 1.5 Perinatal mortality
8
8
Funnel plot of comparison: 1 Any planned birth versus expectant management: by type, outcome: 1.6 Intrauterine death
9
9
Funnel plot of comparison: 1 Any planned birth versus expectant management: by type, outcome: 1.9 Neonatal death
10
10
Funnel plot of comparison: 1 Any planned birth versus expectant management: by type, outcome: 1.15 Birthweight (g)
11
11
Funnel plot of comparison: 1 Any planned birth versus expectant management: by type, outcome: 1.31 Vaginal birth
1.1
1.1. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 1 Neonatal infection/sepsis.
1.2
1.2. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 2 Neonatal infection confirmed with positive blood culture.
1.3
1.3. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 3 Respiratory distress syndrome.
1.4
1.4. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 4 Caesarean section.
1.5
1.5. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 5 Perinatal mortality.
1.6
1.6. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 6 Intrauterine death.
1.7
1.7. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 7 Cord prolapse.
1.8
1.8. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 8 Gestational age at birth (weeks).
1.9
1.9. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 9 Neonatal death.
1.10
1.10. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 10 Suspected neonatal infection.
1.11
1.11. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 11 Neonatal treatment with antibiotics.
1.12
1.12. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 12 Need for ventilation.
1.13
1.13. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 13 Duration of oxygen therapy (days).
1.14
1.14. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 14 Umbilical cord arterial pH.
1.15
1.15. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 15 Birthweight (g).
1.16
1.16. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 16 Apgar score less than 7 at 5 minutes.
1.17
1.17. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 17 Abnormality on cerebral ultrasound.
1.18
1.18. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 18 Periventricular leukomalacia.
1.19
1.19. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 19 Cerebroventricular haemorrhage.
1.20
1.20. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 20 Necrotising enterocolitis.
1.21
1.21. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 21 Severe respiratory distress.
1.22
1.22. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 22 Admission to neonatal intensive care unit.
1.23
1.23. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 23 Length of stay in neonatal intensive care unit (days).
1.24
1.24. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 24 Duration (days) from birth to neonatal hospital discharge.
1.25
1.25. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 25 Chorioamnionitis.
1.26
1.26. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 26 Endometritis.
1.27
1.27. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 27 Postpartum fever.
1.28
1.28. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 28 Placental abruption.
1.29
1.29. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 29 Induction of labour.
1.30
1.30. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 30 Use of epidural/spinal anaesthesia.
1.31
1.31. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 31 Vaginal birth.
1.32
1.32. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 32 Operative vaginal birth.
1.33
1.33. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 33 Caesarean section for fetal distress.
1.34
1.34. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 34 Duration (days) of maternal hospitalisation.
1.35
1.35. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 35 Duration (days) of antenatal hospitalisation.
1.36
1.36. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 36 Duration (days) of maternal hospitalisation (excluding trials with antenatal discharge).
1.37
1.37. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 37 Time (hours) from randomisation to birth.
1.38
1.38. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 38 Disability at 2 years, abnormal CBCL.
1.39
1.39. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 39 Disability at 2 years, abnormal ASQ.
1.40
1.40. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 40 Maternal satisfaction.
1.41
1.41. Analysis
Comparison 1 Any planned birth versus expectant management: by type, Outcome 41 Breastfeeding > 12 weeks.
2.1
2.1. Analysis
Comparison 2 Any planned birth versus expectant management (subgroup analysis by corticosteroid usage), Outcome 1 Neonatal infection.
2.2
2.2. Analysis
Comparison 2 Any planned birth versus expectant management (subgroup analysis by corticosteroid usage), Outcome 2 Neonatal infection confirmed with positive culture.
2.3
2.3. Analysis
Comparison 2 Any planned birth versus expectant management (subgroup analysis by corticosteroid usage), Outcome 3 Respiratory distress syndrome.
2.4
2.4. Analysis
Comparison 2 Any planned birth versus expectant management (subgroup analysis by corticosteroid usage), Outcome 4 Caesarean section.
2.5
2.5. Analysis
Comparison 2 Any planned birth versus expectant management (subgroup analysis by corticosteroid usage), Outcome 5 Chorioamnionitis.
2.6
2.6. Analysis
Comparison 2 Any planned birth versus expectant management (subgroup analysis by corticosteroid usage), Outcome 6 Endometritis.
3.1
3.1. Analysis
Comparison 3 Any planned birth versus expectant management (subgroup analysis by gestational age for inclusion in trial), Outcome 1 Neonatal infection.
3.2
3.2. Analysis
Comparison 3 Any planned birth versus expectant management (subgroup analysis by gestational age for inclusion in trial), Outcome 2 Neonatal infection confirmed with positive culture.
3.3
3.3. Analysis
Comparison 3 Any planned birth versus expectant management (subgroup analysis by gestational age for inclusion in trial), Outcome 3 Respiratory distress syndrome.
3.4
3.4. Analysis
Comparison 3 Any planned birth versus expectant management (subgroup analysis by gestational age for inclusion in trial), Outcome 4 Caesarean section.
3.5
3.5. Analysis
Comparison 3 Any planned birth versus expectant management (subgroup analysis by gestational age for inclusion in trial), Outcome 5 Chorioamnionitis.
3.6
3.6. Analysis
Comparison 3 Any planned birth versus expectant management (subgroup analysis by gestational age for inclusion in trial), Outcome 6 Endometritis.
4.1
4.1. Analysis
Comparison 4 Any planned birth versus expectant management (subgroup analysis by antibiotic use), Outcome 1 Neonatal infection.
4.2
4.2. Analysis
Comparison 4 Any planned birth versus expectant management (subgroup analysis by antibiotic use), Outcome 2 Neonatal infection confirmed with positive culture.
4.3
4.3. Analysis
Comparison 4 Any planned birth versus expectant management (subgroup analysis by antibiotic use), Outcome 3 Respiratory distress syndrome.
4.4
4.4. Analysis
Comparison 4 Any planned birth versus expectant management (subgroup analysis by antibiotic use), Outcome 4 Caesarean section.
4.5
4.5. Analysis
Comparison 4 Any planned birth versus expectant management (subgroup analysis by antibiotic use), Outcome 5 Chorioamnionitis.
4.6
4.6. Analysis
Comparison 4 Any planned birth versus expectant management (subgroup analysis by antibiotic use), Outcome 6 Endometritis.
5.1
5.1. Analysis
Comparison 5 Any planned birth versus expectant management (subgroup analysis by timing of early delivery), Outcome 1 Neonatal infection.
5.2
5.2. Analysis
Comparison 5 Any planned birth versus expectant management (subgroup analysis by timing of early delivery), Outcome 2 Neonatal infection confirmed with positive culture.
5.3
5.3. Analysis
Comparison 5 Any planned birth versus expectant management (subgroup analysis by timing of early delivery), Outcome 3 Respiratory distress syndrome.
5.4
5.4. Analysis
Comparison 5 Any planned birth versus expectant management (subgroup analysis by timing of early delivery), Outcome 4 Caesarean section.
5.5
5.5. Analysis
Comparison 5 Any planned birth versus expectant management (subgroup analysis by timing of early delivery), Outcome 5 Chorioamnionitis.
5.6
5.6. Analysis
Comparison 5 Any planned birth versus expectant management (subgroup analysis by timing of early delivery), Outcome 6 Endometritis.

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References

References to studies included in this review

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References to ongoing studies

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References to other published versions of this review

Buchanan 2010
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