Mechanical methods for induction of labour

Abstract

Background: Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012.

Objectives: To determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low-dose misoprostol (oral and vaginal), amniotomy or oxytocin.

Search methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review.

Selection criteria: Clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods.Mechanical methods include: (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra-amniotic space (EASI).This review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone.

Data collection and analysis: Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach.

Main results: This review update includes a total of 113 trials (22,373 women) contributing data to 21 comparisons. Risk of bias of trials varied. Overall, the evidence was graded from very-low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement.Balloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (average risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; I² = 79%; low-quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate-quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate-quality evidence), serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate-quality evidence) and may slightly reduce the risk of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious maternal morbidity or death (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women) or five-minute Apgar score < 7 (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies) because the quality of the evidence was found to be very low and low, respectively.Balloon versus low-dose vaginal misoprostol: it is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low-quality evidence). A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; 8 studies; moderate-quality evidence) but may increase the risk of a caesarean section (average RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; I² = 45%; low-quality evidence). It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies), serious maternal morbidity or death (no events; 4 studies, 464 women), both very low-quality evidence, and five-minute Apgar score < 7 (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies) and NICU admissions (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies) both low-quality evidence.Balloon versus low-dose oral misoprostol: a balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies, and probably slightly increases the risk of a caesarean section (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; both moderate-quality evidence) when compared to oral misoprostol. It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies), serious neonatal morbidity or perinatal death (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies), both low-quality evidence, serious maternal morbidity or death (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies), very low-quality evidence, five-minute Apgar scores < 7 (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies) and NICU admissions (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies) both low-quality evidence.

Authors' conclusions: Low- to moderate-quality evidence shows mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile. More research on this comparison does not seem warranted.Moderate-quality evidence shows a balloon catheter may be slightly less effective as oral misoprostol, but it remains unclear if there is a difference in safety outcomes for the neonate. When compared to low-dose vaginal misoprostol, low-quality evidence shows a balloon may be less effective, but probably has a better safety profile.Future research could be focused more on safety aspects for the neonate and maternal satisfaction.

Conflict of interest statement

Marieke de Vaan received a grant from The Netherlands Organisation for Scientific Research (NWO) (023.011.051).

Mieke ten Eikelder is co‐author of three included trials (Jozwiak 2013; Jozwiak 2014; ten Eikelder 2016). She has not been involved in the 'Risk of bias' assessment and data extraction of these studies.

Marta Jozwiak is co‐author of four included trials (Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; ten Eikelder 2016). She has not been involved in 'Risk of bias' assessment and data extraction of these studies.

Kirsten Palmer: none known.

Miranda Davies‐Tuck: none known.

Kitty Bloemenkamp is co‐author of four included trials (Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; ten Eikelder 2016). She has not been involved in 'Risk of bias' assessment and data extraction of these studies.

Ben Willem Mol is co‐author of four included trials (Jozwiak 2012; Jozwiak 2013; Jozwiak 2014; ten Eikelder 2016). He has not been involved in 'Risk of bias' assessment and data extraction of these studies. Ben Willem Mol also reports receiving grants from NHMRC Australia, personal fees from ObsEva, grants and personal fees from Merck and Guerbet, outside the submitted work.

Michel Boulvain: none known.

Figures

1

Study flow diagram.

2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

4

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.3 Caesarean section.

5

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.6 Oxytocin augmentation.

6

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.7 Uterine hyperstimulation without fetal heart rate changes.

7

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.10 Instrumental vaginal delivery.

8

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.12 Apgar score

9

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.13 Neonatal intensive care unit admission.

10

Funnel plot of comparison: 1 Balloon (Foley or ATAD) versus vaginal Prostaglandin E2: all women, outcome: 1.21 Fetal distress.

11

Funnel plot of comparison: 4 Balloon (Foley or ATAD) versus intracervical Prostaglandin E2: all women, outcome: 4.3 Caesarean section.

12

Funnel plot of comparison: 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, outcome: 7.3 Caesarean section.

1.1. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

1.2. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

1.3. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 3 Caesarean section.

1.4. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 4 Serious neonatal morbidity/perinatal death.

1.5. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 5 Serious maternal morbidity or death.

1.6. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 6 Oxytocin augmentation.

1.7. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 7 Uterine hyperstimulation without fetal heart rate changes.

1.8. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 8 Uterine rupture.

1.9. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 9 Epidural analgesia.

1.10. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 10 Instrumental vaginal delivery.

1.11. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 11 Meconium‐stained liquor.

1.12. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 12 Apgar score

1.13. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 13 Neonatal intensive care unit admission.

1.14. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 14 Perinatal death.

1.15. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 15 Postpartum haemorrhage.

1.16. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 16 Women not satisfied.

1.17. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 17 Maternal fever during labour.

1.18. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 18 Antibiotics during labour.

1.19. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 19 Chorioamnionitis.

1.20. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 20 Endometritis.

1.21. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 21 Fetal distress.

1.22. Analysis

Comparison 1 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all women, Outcome 22 Umbilical artery pH

2.1. Analysis

Comparison 2 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

2.2. Analysis

Comparison 2 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 2 Uterine hyperstimulation with FHR changes.

2.3. Analysis

Comparison 2 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 3 Caesarean section.

2.4. Analysis

Comparison 2 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 4 Serious neonatal morbidity/perinatal death.

2.5. Analysis

Comparison 2 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all primiparae, Outcome 5 Serious maternal morbidity or death.

3.1. Analysis

Comparison 3 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all multiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

3.2. Analysis

Comparison 3 Balloon (Foley or ATAD) versus vaginal prostaglandin E2: all multiparae, Outcome 2 Caesarean section.

4.1. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

4.2. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

4.3. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 3 Caesarean section.

4.4. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 4 Serious neonatal morbidity/perinatal death.

4.5. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 5 Cervix unfavourable/unchanged after 24 hours.

4.6. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 6 Oxytocin augmentation.

4.7. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 7 Uterine hyperstimulation without FHR changes.

4.8. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 8 Epidural analgesia.

4.9. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 9 Instrumental vaginal delivery.

4.10. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 10 Meconium‐stained liquor.

4.11. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 11 Apgar score

4.12. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 12 Neonatal intensive care unit admission.

4.13. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 13 Perinatal death.

4.14. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 14 Maternal side effects.

4.15. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 15 Postpartum haemorrhage.

4.16. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 16 Chorioamnionitis.

4.17. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 17 Endometritis.

4.18. Analysis

Comparison 4 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all women, Outcome 18 Fetal distress.

5.1. Analysis

Comparison 5 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all primiparae, Outcome 1 Uterine hyperstimulation with FHR changes.

5.2. Analysis

Comparison 5 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all primiparae, Outcome 2 Caesarean section.

6.1. Analysis

Comparison 6 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all multiparae, Outcome 1 Uterine hyperstimulation with FHR changes.

6.2. Analysis

Comparison 6 Balloon (Foley or ATAD) versus intracervical prostaglandin E2: all multiparae, Outcome 2 Caesarean section.

7.1. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

7.2. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

7.3. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 3 Caesarean section.

7.4. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 4 Serious neonatal morbidity/perinatal death.

7.5. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 5 Serious maternal morbidity or death.

7.6. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 6 Cervix unfavourable/unchanged after 12 hours.

7.7. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 7 Oxytocin augmentation.

7.8. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 8 Uterine hyperstimulation without FHR changes.

7.9. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 9 Uterine rupture.

7.10. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 10 Epidural analgesia.

7.11. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 11 Instrumental vaginal delivery.

7.12. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 12 Meconium‐stained liquor.

7.13. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 13 Apgar score

7.14. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 14 Neonatal intensive care unit admission.

7.15. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 15 Perinatal death.

7.16. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 16 Maternal vomiting.

7.17. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 17 Postpartum haemorrhage.

7.18. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 18 Maternal fever during labour.

7.19. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 19 Chorioamnionitis.

7.20. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 20 Endometritis.

7.21. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 21 Fetal distress.

7.22. Analysis

Comparison 7 Balloon (Foley or ATAD) versus low dose vaginal misoprostol: all women, Outcome 22 Umbilical artery pH

8.1. Analysis

Comparison 8 Balloon (Foley or ATAD versus low dose vaginal misoprostol: all primiparae, Outcome 1 Caesarean section.

9.1. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 1 Vaginal delivery not achieved within 24 hours.

9.2. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

9.3. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 3 Caesarean section.

9.4. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 4 Serious perinatal morbidity/perinatal death.

9.5. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 5 Serious maternal morbidity or death.

9.6. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 6 Cervix unfavourable after 24 hours.

9.7. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 7 Oxytocin augmentation.

9.8. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 8 Uterine hyperstimulation without FHR changes.

9.9. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 9 Uterine rupture.

9.10. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 10 Epidural.

9.11. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 11 Instrumental vaginal delivery.

9.12. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 12 Meconium‐stained liquor.

9.13. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 13 Apgar score

9.14. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 14 Neonatal intensive care unit admission.

9.15. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 15 Neonatal encephalopathy.

9.16. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 16 Perinatal death.

9.17. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 17 Maternal side effects (all).

9.18. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 18 Maternal vomiting.

9.19. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 19 Maternal diarrhoea.

9.20. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 20 Postpartum haemorrhage.

9.21. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 21 Maternal death.

9.22. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 22 Women not satisfied.

9.23. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 23 Maternal fever during labour.

9.24. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 24 Antibiotics during labour.

9.25. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 25 Endometritis.

9.26. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 26 Fetal distress.

9.27. Analysis

Comparison 9 Balloon (Foley or ATAD) versus low dose oral misoprostol: all women, Outcome 27 Umbilical artery pH

10.1. Analysis

Comparison 10 Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

10.2. Analysis

Comparison 10 Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 2 Uterine hyperstimulation with FHR changes.

10.3. Analysis

Comparison 10 Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 3 Caesarean section.

10.4. Analysis

Comparison 10 Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 4 Serious neonatal morbidity/perinatal death.

10.5. Analysis

Comparison 10 Balloon (Foley or ATAD) versus low dose oral misoprostol: all primiparae, Outcome 5 Serious maternal morbidity or death.

11.1. Analysis

Comparison 11 Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

11.2. Analysis

Comparison 11 Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 2 Uterine hyperstimulation with FHR changes.

11.3. Analysis

Comparison 11 Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 3 Caesarean section.

11.4. Analysis

Comparison 11 Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 4 Serious neonatal morbidity/perinatal death.

11.5. Analysis

Comparison 11 Balloon (Foley or ATAD) versus low dose oral misoprostol: all multiparae, Outcome 5 Serious maternal morbidity or death.

12.1. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 1 Uterine hyperstimulation with FHR changes.

12.2. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 2 Caesarean section.

12.3. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 3 Serious neonatal morbidity/perinatal death.

12.4. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 4 Serious maternal morbidity or death.

12.5. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 5 Cervix unfavourable after 24 hours.

12.6. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 6 Uterine hyperstimulation without FHR changes.

12.7. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 7 Uterine rupture.

12.8. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 8 Instrumental vaginal delivery.

12.9. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 9 Meconium‐stained liquor.

12.10. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 10 Apgar score

12.11. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 11 Neonatal intensive care unit admission.

12.12. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 12 Perinatal death.

12.13. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 13 Hemorrhagia postpartum.

12.14. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 14 Maternal fever during labour.

12.15. Analysis

Comparison 12 Balloon (Foley or ATAD) versus oxytocin: all women, Outcome 15 Fetal distress.

13.1. Analysis

Comparison 13 Balloon (Foley or ATAD) versus oxytocin: previous caesarean section, Outcome 1 Caesarean section.

13.2. Analysis

Comparison 13 Balloon (Foley or ATAD) versus oxytocin: previous caesarean section, Outcome 2 Serious neonatal morbidity/perinatal death.

13.3. Analysis

Comparison 13 Balloon (Foley or ATAD) versus oxytocin: previous caesarean section, Outcome 3 Serious maternal morbidity or death.

14.1. Analysis

Comparison 14 Balloon (Foley or ATAD) versus oxytocin: all primiparae, Outcome 1 Caesarean section.

14.2. Analysis

Comparison 14 Balloon (Foley or ATAD) versus oxytocin: all primiparae, Outcome 2 Serious maternal morbidity or death.

15.1. Analysis

Comparison 15 Balloon (foley or ATAD) versus amniotomy: all women, Outcome 1 Caesarean section.

16.1. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

16.2. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 2 Uterine hyperstimulation with FHR changes.

16.3. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 3 Caesarean section.

16.4. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 4 Serious maternal morbidity or death.

16.5. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 5 Oxytcocin augmentation.

16.6. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 6 Uterine hyperstimulation without FHR changes.

16.7. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 7 Uterine rupture.

16.8. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 8 Epidural analgesia.

16.9. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 9 Instrumental vaginal delivery.

16.10. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 10 Meconium‐stained liquor.

16.11. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 11 Apgar score

16.12. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 12 Neonatal intensive care unit admission.

16.13. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 13 Other maternal side‐effects: pain after insertion.

16.14. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 14 Postpartum haemorrhage.

16.15. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 15 Maternal fever during labour.

16.16. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 16 Antibiotics during labour.

16.17. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 17 Chorioamnionitis.

16.18. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 18 Endometritis.

16.19. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 19 Fetal distress.

16.20. Analysis

Comparison 16 Single balloon (Foley) versus double balloon (ATAD/Cook): all women, Outcome 20 Umbilical artery pH

17.1. Analysis

Comparison 17 Single balloon (Foley) versus double balloon (ATAD): all primiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

17.2. Analysis

Comparison 17 Single balloon (Foley) versus double balloon (ATAD): all primiparae, Outcome 2 Caesarean section.

18.1. Analysis

Comparison 18 Single balloon (Foley) versus double balloon (ATAD): all multiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

18.2. Analysis

Comparison 18 Single balloon (Foley) versus double balloon (ATAD): all multiparae, Outcome 2 Caesarean section.

19.1. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 1 Uterine hyperstimulation with FHR changes.

19.2. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 2 Caesarean section.

19.3. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 3 Serious perinatal morbidity/perinatal death.

19.4. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 4 Serious maternal morbidity or death.

19.5. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 5 Uterine hyperstimulation without fetal heart rate changes.

19.6. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 6 Epidural analgesia.

19.7. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 7 Instrumental vaginal delivery.

19.8. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 8 Meconium‐stained liquor.

19.9. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 9 Apgar score

19.10. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 10 Perinatal death.

19.11. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 11 Maternal side effects: all.

19.12. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 12 Maternal nausea.

19.13. Analysis

Comparison 19 Laminaria tent versus vaginal prostaglandin E2: all women, Outcome 13 Fetal distress.

20.1. Analysis

Comparison 20 Laminaria tent versus vaginal prostaglandin E2: all primiparae, Outcome 1 Uterine hyperstimulation with FHR changes.

20.2. Analysis

Comparison 20 Laminaria tent versus vaginal prostaglandin E2: all primiparae, Outcome 2 Caesarean section.

21.1. Analysis

Comparison 21 Laminaria tent versus vaginal prostaglandin E2: all multiparae, Outcome 1 Caesarean section.

22.1. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 1 Uterine hyperstimulation with FHR changes.

22.2. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 2 Caesarean section.

22.3. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 3 Serious neonatal morbidity/perinatal death.

22.4. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 4 Serious maternal morbidity or death.

22.5. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 5 Cervix unfavourable/unchanged after 12‐24 hours.

22.6. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 6 Oxytocin augmentation.

22.7. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 7 Uterine hyperstimulation without FHR changes.

22.8. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 8 Uterine rupture.

22.9. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 9 Instrumental vaginal delivery.

22.10. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 10 Apgar score

22.11. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 11 Neonatal intensive care unit admission.

22.12. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 12 Perinatal death.

22.13. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 13 Maternal side effects.

22.14. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 14 Postpartum haemorrhage.

22.15. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 15 Chorioamnionitis.

22.16. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 16 Endometritis.

22.17. Analysis

Comparison 22 Laminaria tent versus intracervical prostaglandin E2: all women, Outcome 17 Fetal distress.

23.1. Analysis

Comparison 23 Laminaria tent versus intracervical prostaglandin E2: all primiparae, Outcome 1 Caesarean section.

24.1. Analysis

Comparison 24 Laminaria tent versus intracervical: prostaglandin E2 all multiparae, Outcome 1 Caesarean section.

25.1. Analysis

Comparison 25 Laminaria tent versus oxytocin: all women, Outcome 1 Caesarean section.

25.2. Analysis

Comparison 25 Laminaria tent versus oxytocin: all women, Outcome 2 Fetal distress.

26.1. Analysis

Comparison 26 Laminaria tent versus amniotomy: all women, Outcome 1 Caesarean section.

27.1. Analysis

Comparison 27 Laminaria tent versus other hygroscopic dilator: all women, Outcome 1 Caesarean section.

28.1. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

28.2. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

28.3. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 3 Caesarean section.

28.4. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 4 Oxytocin augmentation.

28.5. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 5 Uterine hyperstimulation without fetal heart rate changes.

28.6. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 6 Epidural analgesia.

28.7. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 7 Instrumental vaginal delivery.

28.8. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 8 Meconium‐stained liquor.

28.9. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 9 Apgar score

28.10. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 10 Neonatal intensive care unit admission.

28.11. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 11 Woman not satisfied.

28.12. Analysis

Comparison 28 EASI versus vaginal prostaglandin E2: all women, Outcome 12 Fetal distress.

29.1. Analysis

Comparison 29 EASI versus intracervical prostaglandin E2: all women, Outcome 1 Caesarean section.

29.2. Analysis

Comparison 29 EASI versus intracervical prostaglandin E2: all women, Outcome 2 Cervix unfavourable/unchanged after 12‐24 hours.

29.3. Analysis

Comparison 29 EASI versus intracervical prostaglandin E2: all women, Outcome 3 Oxytocin augmentation.

29.4. Analysis

Comparison 29 EASI versus intracervical prostaglandin E2: all women, Outcome 4 Instrumental vaginal delivery.

29.5. Analysis

Comparison 29 EASI versus intracervical prostaglandin E2: all women, Outcome 5 Apgar score

29.6. Analysis

Comparison 29 EASI versus intracervical prostaglandin E2: all women, Outcome 6 Endometritis.

29.7. Analysis

Comparison 29 EASI versus intracervical prostaglandin E2: all women, Outcome 7 Fetal distress.

30.1. Analysis

Comparison 30 EASI versus intracervical prostaglandin E2: all primiparae, Outcome 1 Caesarean section.

31.1. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

31.2. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

31.3. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 3 Caesarean section.

31.4. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 4 Cervix unfavourable/unchanged after 24 hours.

31.5. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 5 Oxytocin augmentation.

31.6. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 6 Uterine hyperstimulation without FHR changes.

31.7. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 7 Epidural analgesia.

31.8. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 8 Instrumental vaginal delivery.

31.9. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 9 Meconium‐stained liquor.

31.10. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 10 Neonatal intensive care unit admission.

31.11. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 11 Postpartum haemorrhage.

31.12. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 12 Chorioamnionitis.

31.13. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 13 Endometritis.

31.14. Analysis

Comparison 31 Any mechanical method and prostaglandin E2 versus prostaglandin E2 alone: all women, Outcome 14 Fetal distress.

32.1. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

32.2. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 2 Caesarean section.

32.3. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 3 Serious neonatal morbidity/perinatal death.

32.4. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 4 Cervix unfavourable/unchanged after 12‐24 hours.

32.5. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 5 Oxytocin augmentation.

32.6. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 6 Uterine hyperstimulation without FHR changes.

32.7. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 7 Instrumental vaginal delivery.

32.8. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 8 Meconium‐stained liquor.

32.9. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 9 Apgar score

32.10. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 10 Neonatal intensive care unit admission.

32.11. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 11 Perinatal death.

32.12. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 12 Chorioamnionitis.

32.13. Analysis

Comparison 32 Any mechanical method and prostaglandin E2 versus low dose misoprostol alone: all women, Outcome 13 Endometritis.

33.1. Analysis

Comparison 33 Any mechanical method and prostaglandin E2 versus oxytocin alone: all women, Outcome 1 Caesarean section.

33.2. Analysis

Comparison 33 Any mechanical method and prostaglandin E2 versus oxytocin alone: all women, Outcome 2 Instrumental vaginal delivery.

33.3. Analysis

Comparison 33 Any mechanical method and prostaglandin E2 versus oxytocin alone: all women, Outcome 3 Endometritis.

34.1. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

34.2. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

34.3. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 3 Caesarean section.

34.4. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 4 Serious neonatal morbidity/perinatal death.

34.5. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 5 Serious maternal morbidity or death.

34.6. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 6 Oxytocin augmentation.

34.7. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 7 Uterine hyperstimulation without fetal heart rate changes.

34.8. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 8 Uterine rupture.

34.9. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 9 Instrumental vaginal delivery.

34.10. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 10 Meconium‐stained liquor.

34.11. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 11 Apgar score

34.12. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 12 Neonatal intensive care unit admission.

34.13. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 13 Perinatal death.

34.14. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 14 Maternal side effects.

34.15. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 15 Maternal nausea.

34.16. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 16 Maternal diarrhoea.

34.17. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 17 Postpartum haemorrhage.

34.18. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 18 Serious maternal complications.

34.19. Analysis

Comparison 34 Any mechanical method and low dose misoprostol versus prostaglandin E2 alone: all women, Outcome 19 Maternal fever during labour.

35.1. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 1 Vaginal delivery not achieved in 24 hours.

35.2. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 2 Uterine hyperstimulation with FHR changes.

35.3. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 3 Caesarean section.

35.4. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 4 Serious neonatal morbidity/perinatal death.

35.5. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 5 Serious maternal morbidity or death.

35.6. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 6 Cervix unfavourable/unchanged after 12 hours.

35.7. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 7 Oxytocin augmentation.

35.8. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 8 Uterine hyperstimulation without FHR changes.

35.9. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 9 Uterine rupture.

35.10. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 10 Epidural analgesia.

35.11. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 11 Instrumental vaginal delivery.

35.12. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 12 Meconium‐stained liquor.

35.13. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 13 Apgar score

35.14. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 14 Neonatal intensive care unit admission.

35.15. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 15 Perinatal death.

35.16. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 16 Maternal side effects.

35.17. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 17 Maternal nausea.

35.18. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 18 Maternal diarrhoea.

35.19. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 19 Postpartum haemorrhage.

35.20. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 20 Serious maternal complications.

35.21. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 21 Chorioamnionitis.

35.22. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 22 Endometrits.

35.23. Analysis

Comparison 35 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all women, Outcome 23 Fetal distress.

36.1. Analysis

Comparison 36 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all primiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

36.2. Analysis

Comparison 36 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all primiparae, Outcome 2 Caesarean section.

37.1. Analysis

Comparison 37 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all multiparae, Outcome 1 Vaginal delivery not achieved in 24 hours.

37.2. Analysis

Comparison 37 Any mechanical method and low dose misoprostol versus low dose misoprostol alone: all multiparae, Outcome 2 Caesarean section.

38.1. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 1 Uterine hyperstimulation with FHR changes.

38.2. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 2 Caesarean section.

38.3. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 3 Serious maternal morbidity or death.

38.4. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 4 Oxytocin augmentation.

38.5. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 5 Uterine hyperstimulation without FHR changes.

38.6. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 6 Instrumental vaginal delivery.

38.7. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 7 Meconium‐stained liquor.

38.8. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 8 Apgar score

38.9. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 9 Neonatal intensive care unit admission.

38.10. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 10 Postpartum haemorrhage.

38.11. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 11 Endometritis.

38.12. Analysis

Comparison 38 Any mechanical method and oxytocin versus prostaglandin E2 alone: all women (not pre‐specified), Outcome 12 Fetal distress.

39.1. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 1 Vaginal delivery not achieved in 24 hours.

39.2. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 2 Uterine hyperstimulation with FHR changes.

39.3. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 3 Caesarean section.

39.4. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 4 Serious neonatal morbidity/perinatal death.

39.5. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 5 Oxytocin augmentation.

39.6. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 6 Uterine hyperstimulation without FHR changes.

39.7. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 7 Epidural analgesia.

39.8. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 8 Meconium‐stained liquor.

39.9. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 9 Apgar score

39.10. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 10 Neonatal intensive care unit admission.

39.11. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 11 Perinatal death.

39.12. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 12 Women not satisfied.

39.13. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 13 Maternal fever.

39.14. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 14 Chorioamnionitis.

39.15. Analysis

Comparison 39 Any mechanical method and oxytocin versus low dose misoprostol alone: all women (not pre‐specified), Outcome 15 Fetal distress.

40.1. Analysis

Comparison 40 Any mechanical method and oxytocin versus low dose misoprostol alone: all multiparae, Outcome 1 Caesarean section.

41.1. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 1 Vaginal delivery not achieved in 24 hours.

41.2. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 2 Caesarean section.

41.3. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 3 Serious neonatal morbidity/perinatal death.

41.4. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 4 Serious maternal morbidity or death.

41.5. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 5 Uterine hyperstimulation without FHR changes.

41.6. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 6 Uterine rupture.

41.7. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 7 Epidural analgesia.

41.8. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 8 Instrumental vaginal delivery.

41.9. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 9 Meconium‐stained liquor.

41.10. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 10 Neonatal intensive care unit admission.

41.11. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 11 Postpartum haemorrhage.

41.12. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 12 Serious maternal complications.

41.13. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 13 Antibiotics during labour.

41.14. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 14 Chorionamnionitis.

41.15. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 15 Endometritis.

41.16. Analysis

Comparison 41 Any mechanical method and oxytocin versus oxytocin alone: all women (not pre‐specified), Outcome 16 Fetal distress.

References

References to studies included in this review Aduloju 2016 {published data only}

Ahmed 2016 {published data only} Al‐Ibraheemi 2018 {published data only} Allouche 1993 {published data only} Al‐Taani 2004 {published data only} Amorosa 2017 {published data only} Atad 1996 {published data only} Bagratee 1990 {published data only} Barda 2018 {published data only} Benzineb 1996 {published data only} Biron‐Shental 2004 {published data only} Blumenthal 1990 {published data only} Browne 2011 {published data only} Carbone 2013 {published data only} Casey 1995 {published data only} Chavakula 2015 {published data only} Chua 1997 {published data only} Cromi 2011 {published data only} Cromi 2012 {published data only} Culver 2004 {published data only} Dalui 2005 {published data only} Deo 2012 {published data only} Deo 2013 {published data only} Deshmukh 2011 {published data only} Dionne 2011 {published data only} Edwards 2014c {published data only} El Khouly 2017 {published data only} Filho 2002 {published data only} Garba 2016 {published data only} Gelisen 2005 {published data only} Gilson 2017 {published data only} Glagoleva 1999 {published data only} Goonewardene 2014 {published data only} Guinn 2000 {published data only} Gunawardena 2012 {published data only} Haugland 2012 {published data only} Hay 1995 {published data only} Hemlin 1998 {published data only} Henry 2013 {published data only} Hibbard 1998 {published data only} Hoppe 2016 {published data only} Hudon 1999 {published data only} Hughes 2002 {published data only} Husain 2017 {published data only} Jagani 1982 {published data only} Jalilian 2011 {published data only} Jeeva 1982 {published data only} Johnson 1985 {published data only} Joshi 2016 {published data only} Jozwiak 2012 {published data only} Jozwiak 2013 {published data only} Jozwiak 2014 {published data only} Kandil 2012 {published data only} Khamaiseh 2012 {published data only} Krammer 1995a {published data only} Kruit 2016 {published data only} Kuppulakshmi 2016 {published data only} Laddad 2013 {published data only} Lanka 2014 {published data only} Lemyre 2006 {published data only} Lewis 1983 {published data only} Lokkegaard 2015 {published data only} Lyndrup 1989 {published data only} Lyndrup 1994 {published data only} Mackeen 2018 {published data only} Matonhodze 2003 {published data only} Mazhar 2003 {published data only} Meetei 2015 {published data only} Moini 2003 {published data only} Mullin 2002 {published data only} Mundle 2017 {published data only} Niromanesh 2003 {published data only} Noor 2015 {published data only} Ntsaluba 1997 {published data only} Oliveira 2010 {published data only} Ophir 1992 {published data only} Orhue 1995 {published data only} Peedicayil 1998 {published data only} Pennell 2009 {published data only} Perry 1998 {published data only} Pineda Rivas 2016 {published data only} Prager 2008 {published data only} Qamar 2012 {published data only} Ridgway 1991 {published data only} Roberts 1986 {published data only} Rouben 1993 {published data only} Roudsari 2011 {published data only} Roztocil 1998 {published data only} Rudra 2012 {published data only} Saleem 2006 {published data only} Salim 2011 {published data only} Sanchez‐Ramos 1992 {published data only} Sarreau 2016 {published data only} Sciscione 1999 {published data only} Sharami 2005 {published data only} Shechter‐Maor 2015 {published data only} Sheikher 2009 {published data only} Solt 2009 {published data only} Somirathne 2017 {published data only} St Onge 1995 {published data only} Suffecool 2014 {published data only} Sullivan 1996 {published data only} Tabowei 2003 {published data only} Tan 2015 {published data only} ten Eikelder 2016 {published data only} Thiery 1981 {published data only} Tita 2006 {published data only} Turnquest 1997 {published data only} Wang 2012 {published data only} Wang 2014 {published data only} Wu 2017 {published data only} Yuen 1996 {published data only} Zahoor 2014 {published data only} References to studies excluded from this review Abramovici 1999 {published data only} Adeniji 2005a {published data only} Adeniji 2005b {published data only} Adeniji 2006 {published data only} Afolabi 2005 {published data only} Ahmad 2015 {published data only} Anabosy 2014 {published data only} Arsenijevic 2012 {published data only} Arshad 2016 {published data only} Atad 1991 {published data only} Atad 1999 {published data only} Baacke 2006 {published data only} Barrilleaux 2002a {published data only} Behrashi 2013 {published data only} Ben‐Aroya 2001 {published data only} Buccellato 2000 {published data only} Cahill 1988 {published data only} Caughey 2007 {published data only} Chipato 1997 {published data only} Chung 2003 {published data only} Connolly 2016 {published data only} Connolly 2017 {published data only} Cross 1978 {published data only} Cullimore 2009 {published data only} Delaney 2010 {published data only} Demirel 2015 {published data only} De Oliveira 2003 {published data only} Dias 2008 {published data only} Du 2015 {published data only} Edwards 2017 {published data only} El‐Khayat 2016 {published data only} El Sharkwy 2017 {published data only} El‐Torkey 1995 {published data only} Emery 1988 {published data only} EUCTR 2012 {published data only} Filshie 1992 {published data only} Forgie 2016 {published data only} Forooshani 2011 {published data only} Fruhman 2017 {published data only} Gadel 2015 {published data only} Garebedian 2016 {published data only} Ghanaei 2009 {published data only} Ghanaie 2013 {published data only} Gibson 2013 {published data only} Gilson 1996 {published data only} Gonsoulin 1989 {published data only} Gower 1982 {published data only} Greybush 2001 {published data only} Gu 2015 {published data only} Guinn 2004 {published data only} Haghighi 2015 {published data only} Hallak 2008 {published data only} He 2000 {published data only} Hill 2009 {published data only} Hill 2013 {published data only} Hussein 2012 {published data only} Ifnan 2006 {published data only} Jagani 1984 {published data only} Jasper 2000 {published data only} Jindal 2007 {published data only} Jonsson 2011 {published data only} Kamilya 2011 {published data only} Karjane 2006 {published data only} Kasdaglis 2007 {published data only} Kashanian 2006 {published data only} Kashanian 2009a {published data only} Kehl 2012 {published data only} Kehl 2015 {published data only} Keirse 1983 {published data only} Lackritz 1979 {published data only} Lam 2006 {published data only} Leiberman 1977 {published data only} Leong 2017 {published data only} Levine 2016 {published data only} Levy 2000 {published data only} Levy 2004 {published data only} Lin 1995 {published data only} Lin 2006 {published data only} Lin 2007 {published data only} Lutgendorf 2012 {published data only} Macpherson 1983 {published data only} Mahomed 1988 {published data only} Manabe 1985 {published data only} Manish 2016 {published data only} Manyonda 2007 {published data only} Martin 1989 {published data only} Mattingly 2015 {published data only} Mawire 1999 {published data only} McGee 2016 {published data only} Mei‐Dan 2009 {published data only} Mei‐Dan 2012 {published data only} Mei‐Dan 2012a {published data only} Mei‐Dan 2014 {published data only} Miller 2015 {published data only} Moise 1991 {published data only} Morrison 1993 {published data only} Movahed 2016 {published data only} Mullin 2014 {published data only} Naseem 2007 {published data only} Nasir 2012 {published data only} Neethurani 2013 {published data only} Owolabi 2005 {published data only} Park 2011 {published data only} Pathiraja 2014 {published data only} Pedersen 1981 {published data only} Pettker 2008 {published data only} Rameez 2007 {published data only} Reif 2012 {published data only} Rezk 2014 {published data only} Rust 2001 {published data only} Saad 2016 {published data only} Saito 1999 {published data only} Salmeen 2012 {published data only} Sanchez‐Ramos 1990 {published data only} Sandberg 2017 {published data only} Schoen 2017 {published data only} Schreyer 1989 {published data only} Sciscione 2001 {published data only} Sharma 2015a {published data only} Sharma 2017 {published data only} Sherman 2001 {published data only} Siddiqui 2013 {published data only} Suri 2000 {published data only} Thigpen 2004 {published data only} Thomas 1986 {published data only} Torbenson 2015 {published data only} Ugwu 2013 {published data only} Vengalil 1998 {published data only} Walfisch 2014 {published data only} Walfisch 2015 {published data only} Welt 1987 {published data only} Wickramasinghe 2014 {published data only} Wilkinson 2015 {published data only} Yaddehige 2015 {published data only} Yazdani 2011 {published data only} Zakaria 2017 {published data only} Zhang 2014 {published data only} Zimmer 1996 {published data only} References to studies awaiting assessment ACTRN12618000510246 2018 {published data only} Agboghoroma 2015 {published data only} Amorosa 2017a {published data only} Bauer 2018 {published data only} Chai 2018 {published data only} Cherian 2018 {published data only} CTRI/2018/01/011574 {published data only} DeCesare 2018 {published data only} de Vaan 2019 {published data only} Diguisto 2017 {published data only} EUCTR2017‐001914‐27‐GB 2018 {published data only} IRCT20170326033142N2 2018 {published data only} IRCT20170513033941N39 2018 {published data only} IRCT20181123041731N1 2019 {published data only} Khatib 2019 {published data only} Leigh 2018 {published data only} Lim 2018 {published data only} Mallah 2011 {published data only} McGee 2018 {published data only} Mohamad 2018 {published data only} NCT03172858 2017 {published data only} NCT03399266 2018 {published data only} NCT03435458 2018 {published data only} NCT03588585 2018 {published data only} NCT03629548 {published data only} NCT03629548 2018 {published data only} NCT03670836 2018 {published data only} NCT03682718 2018 {published data only} NCT03744078 2018 {published data only} NCT03752073 2018 {published data only} NCT03866772 2019 {published data only} Oskei 2018 {published data only} Osoti 2018 {published data only} Saad 2019 {published data only} Sanmugam 2018 {published data only} Souizi 2018 {published data only} ten Eikelder 2017 {published data only} Tulek 2018 {published data only} Viteri 2019 {published data only} References to ongoing studies Argilagos 2016 {published data only} Beckmann 2013 {published data only} Bekele 2017 {published data only} Berndl 2016 {published data only} Bhide 2017 {published data only} Eser 2016 {published data only} Goli 2017 {published data only} Goonewardene 2016 {published data only} Gupta 2016 {published data only} Hassanzadeh 2017 {published data only} Igwe 2017 {published data only} Lacarin 2017 {published data only} Lauterbach 2017 {published data only} Levy 2016 {published data only} Osoti 2016 {published data only} Park 2012 {published data only} Perrotin 2016 {published data only} Tagore 2015 {published data only} Viteri 2015 {published data only} Wise 2016 {published data only} Yildirim 2017 {published data only} Additional references Abramovici 1994 Alferivic 2009 Alfirevic 2014 Alfirevic 2016 Boulvain 2005 Boulvain 2008 Bricker 2000 Chen 2016 Curtis 1987 Du 2017 Higgins 2011 Hofmeyr 2009 Hofmeyr 2010 Howarth 2001 Krammer 1995b Liu 2018 McMaster 2015 NHS 2017 NICE 2008 RevMan 2014 [Computer program] Ten Eikelder 2016 Thiery 1989 Thomas 2014 Wang 2016 WHO 2011 Zhu 2018 References to other published versions of this review Boulvain 2001 Jozwiak 2012 Keirse 1995