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Title: | Mechanical methods for induction of labour. | Authors: | ten Eikelder M.L.G.;Boulvain M.;Mol B.W.J. ;Bloemenkamp K.W.M.;Jozwiak M.;de Vaan M.D.T.;Davies-Tuck M.;Palmer, Kirsten R. | Monash Health Department(s): | Obstetrics and Gynaecology (Monash Women's) | Institution: | (de Vaan) Jeroen Bosch Hospital, Department of Obstetrics, Henri Dunantstraat 1, 's-Hertogenbosch 5223 GZ, Netherlands (de Vaan) Rotterdam University of Applied Sciences, Department of Health Care Studies, Rotterdam, Netherlands (ten Eikelder) Royal Cornwall Hospital NHS Trust, Department of Obstetrics and Gynaecology, Princess Alexandra Wing, Treliske, Truro, United Kingdom (Jozwiak) Erasmus Medical Center, Dr Molewaterplein 40, Rotterdam 3015 GD, Netherlands (Palmer) Monash Health and Monash University, Department of Obstetrics and Gynaecology, 246 Clayton Road, Clayton, VIC 3168, Australia (Davies-Tuck) Monash University, Clayton, VIC, Australia (Bloemenkamp) Birth Centre Wilhelmina's Children Hospital, University Medical Center Utrecht, Department of Obstetrics, Division Women and Baby, Utrecht, Netherlands (Mol) Monash University, Department of Obstetrics and Gynaecology, 246 Clayton Road, Clayton, VIC 3168, Australia (Boulvain) University of Geneva/GHOL-Nyon Hospital, Department of Gynecology and Obstetrics, NYON, Switzerland | Issue Date: | 1-Oct-2020 | Copyright year: | 2019 | Publisher: | John Wiley and Sons Ltd (E-mail: cs-journals@wiley.co.uk) | Place of publication: | United Kingdom | Publication information: | Cochrane Database of Systematic Reviews. 2019 (10) (no pagination), 2019. Article Number: CD001233. Date of Publication: 18 Oct 2019. | Journal: | Cochrane Database of Systematic Reviews | 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. Objective(s): 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 Method(s): 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 Result(s): 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.Copyright © 2019 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1002/14651858.CD001233.pub3 | PubMed URL: | 31623014 [http://www.ncbi.nlm.nih.gov/pubmed/?term=31623014] | ISSN: | 1469-493X (electronic) | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/35326 | Type: | Review | Subjects: | single balloon catheter/dc [Device Comparison] patient satisfaction perinatal death postpartum hemorrhage/co [Complication] cesarean section chorioamnionitis/co [Complication] drug dose increase drug dose titration endometritis/co [Complication] epidural analgesia fetus distress/co [Complication] fetus heart rate fever/co [Complication] hospital admission human instrumental delivery *labor induction low drug dose maternal death maternal morbidity meconium multipara neonatal intensive care unit newborn morbidity patient safety primipara priority journal repeated drug dose review systematic review therapy effect third trimester pregnancy treatment outcome umbilical artery uterine cervix ripening uterus rupture/co [Complication] vaginal delivery antibiotic agent dilapan/va [Intravaginal Drug Administration] lamicel/va [Intravaginal Drug Administration] misoprostol/va [Intravaginal Drug Administration] misoprostol/po [Oral Drug Administration] oxytocin/cb [Drug Combination] oxytocin/cm [Drug Comparison] oxytocin/iv [Intravenous Drug Administration] prostaglandin E2/cm [Drug Comparison] prostaglandin E2/ut [Intrauterine Drug Administration] prostaglandin E2/va [Intravaginal Drug Administration] sodium chloride/cb [Drug Combination] sodium chloride/cm [Drug Comparison] balloon catheter Foley balloon catheter hygroscopic Laminaria cervical dilator vagina pessary double balloon catheter/dc [Device Comparison] amniotomy Apgar score fetus distress / complication fetus heart rate fever / complication hospital admission human instrumental delivery *labor induction low drug dose maternal death patient safety patient satisfaction perinatal death postpartum hemorrhage / complication primipara priority journal repeated drug dose Review systematic review therapy effect third trimester pregnancy treatment outcome umbilical artery uterine cervix ripening vaginal delivery newborn morbidity neonatal intensive care unit multipara uterus rupture / complication amniotomy Apgar score cesarean section chorioamnionitis / complication drug dose increase drug dose titration endometritis / complication epidural analgesia meconium maternal morbidity |
Type of Clinical Study or Trial: | Systematic review and/or meta-analysis |
Appears in Collections: | Articles |
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