Methods for cervical ripening and labour induction in late pregnancy: generic protocol

Hofmeyr, G Justus; Alfirević, Z̄arko; Kelly, Anthony; Kavanagh, Jennifer; Thomas, Justin; Neilson, James P; Dowswell, Therese

doi:10.1002/14651858.cd002074.pub2

Cited by 43 publications

(19 citation statements)

References 39 publications

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“…We also tested the robustness of both the inclusion criteria and clinical protocols for outpatient ripening. There were also no statistically significant differences for any of the other clinically relevant outcomes of cervical ripening as specified by Hofmeyr 18 for trials of induction of labour, including vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, and serious neonatal and maternal morbidity.…”

Section: Main Findingsmentioning

confidence: 85%

A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study)

Wilkinson

Bryce

Adelson

et al. 2014

BJOG

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Objective To compare clinical outcomes from outpatient with inpatient cervical prostaglandin E2 ripening for low risk labour induction.Design Randomised controlled trial.Setting Two tertiary hospitals in Adelaide, Australia.Population Women with uncomplicated term pregnancies, scheduled for induction of labour for reasons of post-dates or for social reasons.Methods Eight hundred and twenty-seven women were randomised at induction decision to an outpatient or inpatient group. All women had CTG monitoring before and after vaginal PgE2 administration. The inpatient women were admitted and the outpatient group was discharged home overnight with instructions to return if labour established or rupture of membranes occurred. Next morning, outpatient women were admitted for rupture of membranes or further ripening. After membrane rupture, both groups received routine care.Main outcome measures Oxytocin use, maternal and fetal outcomes, and whether planned outpatient management was achievable.Results There were no significant differences in oxytocin use (2.5% difference, CIÀ4.3 to 9.4), caesarean sections (À0.59% difference, CIÀ6.3 to 5.1), epidural use (1.5% difference, CIÀ5.1 to 8.2), vaginal delivery within 24 hours (À8.2% difference, CIÀ17.6 to 1.3) or labour complications. More than half of the randomised women did not receive the intervention as they laboured spontaneously, or did not require ripening. The post-hoc analysis of women who received ripening also indicated no statistically significant differences in the patterns or results, with the exception of outpatient women having a longer mean length of active labour (mean difference 66 minutes, CI 4-128 minutes). Outpatient women who received ripening were diagnosed more frequently with non-reassuring CTG monitoring and hyperstimulation, with less than half of the women going home and remaining home overnight.Conclusions This study demonstrated no clinical advantage or disadvantage in prostaglandin E2 outpatient cervical ripening. Uterine stimulation following prostaglandins may preclude a woman from going home or remaining at home overnight and may not be the best agent for outpatient ripening.

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Section: Main Findingsmentioning

confidence: 85%

A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study)

Wilkinson

Bryce

Adelson

et al. 2014

BJOG

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“…However, for comparisons of methods with each other, we followed the pre-specified hierarchy used for the series of induction of labour Cochrane Reviews and arranged labour induction methods in that specific order [2]. In each subsection of this paper, we compare each method with those methods prior to it on this list.…”

Section: Methodsmentioning

confidence: 99%

Methods of induction of labour: a systematic review

Mozurkewich

Chilimigras

Berman

et al. 2011

BMC Pregnancy Childbirth

186

141

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BackgroundRates of labour induction are increasing. We conducted this systematic review to assess the evidence supporting use of each method of labour induction.MethodsWe listed methods of labour induction then reviewed the evidence supporting each. We searched MEDLINE and the Cochrane Library between 1980 and November 2010 using multiple terms and combinations, including labor, induced/or induction of labor, prostaglandin or prostaglandins, misoprostol, Cytotec, 16,16,-dimethylprostaglandin E2 or E2, dinoprostone; Prepidil, Cervidil, Dinoprost, Carboprost or hemabate; prostin, oxytocin, misoprostol, membrane sweeping or membrane stripping, amniotomy, balloon catheter or Foley catheter, hygroscopic dilators, laminaria, dilapan, saline injection, nipple stimulation, intercourse, acupuncture, castor oil, herbs. We performed a best evidence review of the literature supporting each method. We identified 2048 abstracts and reviewed 283 full text articles. We preferentially included high quality systematic reviews or large randomised trials. Where no such studies existed, we included the best evidence available from smaller randomised or quasi-randomised trials.ResultsWe included 46 full text articles. We assigned a quality rating to each included article and a strength of evidence rating to each body of literature. Prostaglandin E2 (PGE2) and vaginal misoprostol were more effective than oxytocin in bringing about vaginal delivery within 24 hours but were associated with more uterine hyperstimulation. Mechanical methods reduced uterine hyperstimulation compared with PGE2 and misoprostol, but increased maternal and neonatal infectious morbidity compared with other methods. Membrane sweeping reduced post-term gestations. Most included studies were too small to evaluate risk for rare adverse outcomes.ConclusionsResearch is needed to determine benefits and harms of many induction methods.

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“…Using terminology defined by Curtis [29], tachysystole was considered a contraction frequency of more than five in a 10 minute period for two consecutive 10 minute periods, and hyperstimulation, the presence of tachysystole with late FHR decelerations, or other worrisome FHR changes. Other prespecified outcomes included labor intervals to vaginal birth (time to full dilation, and length of labor stages), frequency of maternal interventions and morbidity, birth method-vaginal (spontaneous, vacuum, or forceps) and cesarean, and frequency of vaginal birth within specified intervals following induction, such as within 24 hours (as encouraged by Cochrane [30]). Maternal satisfaction with labor was evaluated by questionnaire [31], which is provided in Supporting Information, S1 Study Protocol, pages 21-24.…”

Section: Methodsmentioning

confidence: 99%

“…This RCT includes data on all five primary outcomes recommended in the Cochrane Library generic protocol for cervical ripening and induction [30]. In addition, data are reported on more than 80% of the other secondary outcomes in Cochrane [17,30]. The largest impact of adding this manuscript's results would be in meta-analyses of 50 μg oral misoprostol versus vaginal dinoprostone where any Cochrane meta-analysis includes four or fewer RCTs.…”

Section: Oral Misoprostolmentioning

confidence: 99%

“…No RCTs in the Cochrane Library using oral misoprostol versus vaginal dinoprostone and only one of oral misoprostol versus vaginal misoprostol, including 204 subjects, have reported on maternal satisfaction [17]. Cochrane encourages use of vaginal birth not achieved in 24 hours as a primary outcome [30]. Others [22] feel this is problematic as it discounts successful, though longer duration, vaginal births.…”

Section: Oral Misoprostolmentioning

confidence: 99%

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Oral misoprostol, low dose vaginal misoprostol, and vaginal dinoprostone for labor induction: Randomized controlled trial

et al. 2020

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Objective To compare effectiveness and safety of oral misoprostol (50 μg every four hours as needed), low dose vaginal misoprostol (25 to 50 μg every six hours as needed), and our established dinoprostone vaginal gel (one to two mg every six hours as needed) induction. Materials and methods Consenting women with a live term single cephalic fetus for indicated labor induction were randomized (3N = 511). Prior uterine surgery or non-reassuring fetal surveillance were exclusions. Concealed computer generated randomization was stratified and blocked. Newborns were assessed by a team unaware of group assignment. The primary outcome was time from induction at randomization to vaginal birth for initial parametric analysis. Sample size was based on mean difference of 240 minutes with α 2 = 0.05 and power 95%. Nonparametric analysis was also pre-specified ranking cesareans as longest vaginal births. Results Enrollment was from April 1999 to December 2000. Demographics were similar across groups. Analysis was by intent to treat, with no loss to follow up. Mean time (±SD) to vaginal birth was 1356 (±1033) minutes for oral misoprostol, 1530 (±3249) minutes for vaginal misoprostol, and 1208 (±613) minutes for vaginal dinoprostone (P = 0.46, ANOVA). Median times to vaginal birth were 1571, 1339, and 1451 minutes respectively (P = 0.46, Kruskal-Wallis). Vaginal births occurred within 24 hours in 44.9, 53.5 and 47.7% respectively (P = 0.27, χ 2). There were no significant differences in Kaplan Meier survival analyses, cesareans, adverse effects, or maternal satisfaction. The newborn who met birth asphyxia criteria received vaginal misoprostol, as did. all three other newborns with cord artery pH<7.0 (P = 0.04, Fisher Exact).

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Methods for cervical ripening and labour induction in late pregnancy: generic protocol

Cited by 43 publications

References 39 publications

A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study)

A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study)

Methods of induction of labour: a systematic review

Oral misoprostol, low dose vaginal misoprostol, and vaginal dinoprostone for labor induction: Randomized controlled trial

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Methods for cervical ripening and labour induction in late pregnancy: generic protocol

Cited by 43 publications

References 39 publications

A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E2 (OPRA study)

A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E2 (OPRA study)

Methods of induction of labour: a systematic review

Oral misoprostol, low dose vaginal misoprostol, and vaginal dinoprostone for labor induction: Randomized controlled trial

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Product

Resources

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A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study)

A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study)