Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial

Mundle, Shuchita; Bracken, Hillary; Khedikar, Vaishali; Mulik, Jayashree; Faragher, Brian; Easterling, Thomas R.; Leigh, Simon; Granby, Paul; Haycox, Alan; Turner, Mark A.; Alfirević, Z̄arko; Winikoff, Beverly; Weeks, Andrew

doi:10.1016/s0140-6736(17)31367-3

Cited by 41 publications

(93 citation statements)

References 20 publications

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“…A total of 10 studies reported on the occurrence in 18 women. 18,19,22 Two of these neonates had good Apgar scores and information of the third one was not available to us. In some women, the catheter had to be removed and ripening had to be pursued with a different method.…”

Section: Vaginal Bleedingmentioning

confidence: 99%

“…A total of six studies reported on the occurrence in 31 women. In these women either a different method of induction was performed 18 or induction was continued with the balloon catheter and prophylactic antibiotics were started. In some women the catheter had to be removed, [14][15][16] but mostly induction of labour was continued normally.…”

Section: Pain/discomfortmentioning

confidence: 99%

“…18,19 In other women a CS was performed. In some women, the induction of labour was continued normally 9 or the balloon catheter was removed.…”

Section: Balloon Displacementmentioning

confidence: 99%

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Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review

Diederen

Gommers

Wilkinson

et al. 2018

BJOG

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Section: Vaginal Bleedingmentioning

confidence: 99%

Section: Pain/discomfortmentioning

confidence: 99%

See 1 more Smart Citation

Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review

Diederen

Gommers

Wilkinson

et al. 2018

BJOG

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“…Full details of the sample size calculation, in addition to data concerning the occurrence of adverse events, which bore no clear and translatable cost to the healthcare providers (e.g. headache, maternal vomiting, and meconium‐stained liquor), are reported elsewhere …”

Section: Methodsmentioning

confidence: 99%

“…To date, the sum of available evidence suggests both methods are promising; however, the relative cost‐effectiveness of these methods for induction of labour in women with gestational hypertension remains unknown in low‐resource settings. We conducted a cost‐consequence analysis of a previously reported multicentre randomised controlled trial (RCT), comparing oral misoprostol with Foley balloon induction in women with gestational hypertension. We compared the respective efficacy, healthcare resource utilisation, and adverse event profile of these therapeutic indications for the induction of labour among those with gestational hypertension in a low‐resource setting.…”

Section: Introductionmentioning

confidence: 99%

Foley catheter vs. oral misoprostol to induce labour among hypertensive women in India: a cost‐consequence analysis alongside a clinical trial

Leigh

Granby

Haycox

et al. 2018

BJOG

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ObjectiveTo determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low‐resource settings.DesignCost‐consequence analysis of a previously reported multicentre, parallel, open‐label randomised trial.Setting & populationA total of 602 women with a live fetus, aged ≥18 years requiring delivery for pre‐eclampsia or hypertension, in two public hospitals in Nagpur, India.MethodsWe performed a formal economic evaluation alongside the INFORM clinical trial. Women were randomised to receive transcervical Foley catheterisation or oral misoprostol 25 mcg. Healthcare expenditure was calculated using a provider‐side microcosting approach.Main outcome measuresRates of vaginal this delivery within 24 hours of induction, healthcare expenditure per completed treatment episode.ResultsInduction with oral misoprostol resulted in a (mean difference) $20.6USD reduction in healthcare expenditure [95% CI (−) $123.59 (−) $72.49], and improved achievement of vaginal delivery within 24 hours of induction, mean difference 10% [95% CI (−2 to 17.9%), P = 0.016]. Oxytocin administration time was reduced by 135.3 minutes [95% CI (84.4–186.2 minutes), P < 0.01] and caesarean sections by 9.1% [95% CI (1.1–17%), P = 0.025] for those receiving oral misoprostol. Following probabilistic sensitivity analysis, oral misoprostol was cost‐saving in 63% of 5,000 bootstrap replications and achieved superior rates of vaginal delivery, delivery within 24 hours of induction and vaginal delivery within 24 hours of induction in 98.7%, 90.7%, and 99.4% of bootstrap simulations. Based on univariate threshold analysis, the unit price of oral misoprostol 25 mcg could feasibly increase 31‐fold from $0.24 to $7.50 per 25 mcg tablet and remain cost‐saving.ConclusionCompared to Foley catheterisation for the induction of high‐risk hypertensive women, oral misoprostol improves rates of vaginal delivery within 24 hours of induction and may also reduce costs. Additional research performed in other low‐resource settings is required to determine their relative cost‐effectiveness.Tweetable abstractOral misoprostol less costly and more effective than Foley catheter for labour induction in hypertension.

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Mechanical methods for induction of labour

Vaan

Eikelder

Jozwiak

et al. 2019

Cochrane Database of Systematic Reviews

101

117

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BackgroundMechanical 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.ObjectivesTo 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 methodsFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, , the WHO International Clinical Trials Registry Platform (), 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 criteriaClinical 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 analysisTwo 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 resultsThis 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 ...

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Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial

Cited by 41 publications

References 20 publications

Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review

Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review

Foley catheter vs. oral misoprostol to induce labour among hypertensive women in India: a cost‐consequence analysis alongside a clinical trial

Mechanical methods for induction of labour

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