Double-balloon catheter and sequential oral misoprostol versus oral misoprostol alone for induction of labour at term: a retrospective cohort study

Kehl, Sven; Weiß, Christel; Dammer, Ulf; Heimrich, Jutta; Beckmann, Matthias W.; Faschingbauer, Florian; Sütterlin, Marc

doi:10.1016/j.ejogrb.2016.07.507

Cited by 15 publications

(12 citation statements)

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“…The main finding of this study was the lower caesarean section rate when labour was induced with sequential balloon catheter and misoprostol. Similar results were found in previous studies evaluating the whole population with obese and non-obese women [15,24]. The difference in the cesarean section rate of 18% (38,6% versus 56,9%) is similar to the 13% in the mixed collective 24].…”

Section: Discussionsupporting

confidence: 88%

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Induction of labour with sequential double-balloon catheter and oral misoprostol versus oral misoprostol alone in obese women

Kehl

Born

Weiß

et al. 2019

European Journal of Obstetrics & Gynecology and Reproductiv

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Objective To evaluate the efficacy of induction of labour in obese women using sequential double-balloon catheter and oral misoprostol in comparison with oral misoprostol alone. Study design In this cohort study, 400 pregnant women with BMI higher than 35 kg/m2 undergoing labour induction at term were included. Induction of labour with a double-balloon catheter and, if necessary, sequential oral misoprostol (n = 216) was compared to oral misoprostol alone (n = 184). The primary outcome measure was the caesarean section rate. Secondary outcome parameters were, among others, the induction-to-delivery-interval, the rate of vaginal delivery within 24 and 48 h as well as fetal outcome parameters. Results The caesarean section rate was significantly lower in the group with sequential use of double-balloon catheter and oral misoprostol (27.6% versus 37.5%, p = 0.0345). After stratification for parity this reduction was seen especially in nulliparous (38.6% versus 56.9%, p = 0.0039). The rate of abnormal CTG was significantly lower as well (19.9% versus 30.4%, p = 0.0150), particularly in nulliparous (25.9% versus 40.4%, p = 0.0138). Uni- and multivariable analyzes showed that the caesarean section rate was significantly influenced by the method of induction of labour (p = 0.0026), parity (p < 0.0001) and Bishop score (p = 0.0425). Conclusion In obese women, induction of labour with sequential use of double-balloon catheter and oral misoprostol is associated with significantly more normal vaginal deliveries and less caesarean sections.

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Section: Discussionsupporting

confidence: 88%

“…Similar results were found in previous studies evaluating the whole population with obese and non-obese women [15,24]. The difference in the cesarean section rate of 18% (38,6% versus 56,9%) is similar to the 13% in the mixed collective 24]. Ande et al could even show a reduced caesarean section rate by 20% [14].…”

Section: Discussionsupporting

confidence: 86%

Induction of labour with sequential double-balloon catheter and oral misoprostol versus oral misoprostol alone in obese women

Kehl

Born

Weiß

et al. 2019

European Journal of Obstetrics & Gynecology and Reproductiv

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“…To our knowledge this study will be the first RCT comparing transcervical FCB with vaginal PGE2 in women attempting VBAC, and will address the knowledge gap regarding the optimal method for cervical ripening and labour induction in this patient population, where current data are derived mainly from retrospective analyses and observational studies with small patient numbers and protocol heterogeneity 65. By comparison, the ongoing PROBAAT-S trial (http://www.studies-obsgyn.nl/probaats/page.asp?page_id=1048) is a large prospective observational study designed to compare IOL by prostaglandins, FCB or amniotomy in women with at least one previous CS, in which the primary outcome is neonatal and maternal morbidity rather than mode of delivery.…”

Section: Discussion Ethics and Disseminationmentioning

confidence: 99%

MEchanical DIlatation of the Cervix in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

et al. 2019

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IntroductionLabour induction in women with a previous caesarean delivery currently uses vaginal prostaglandin E2 (PGE2), which carries the risks of uterine hyperstimulation and scar rupture. We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC).Methods and analysisThis single-centre non-inferiority prospective, randomised, open, blinded-endpoint study conducted at an academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery. Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (≤5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50). Treatments are applied for up to 12 hours with serial monitoring of the mother and the fetus and serial assessment for improved cervical scores. If the cervix is still unfavourable, participants are allowed a further 12 hours’ observation for cervical ripening. Active labour is initiated by amniotomy at cervical scores of ≥6. The primary outcome is the rate of change in the cervical score, and secondary outcomes include active labour within 24 hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation. All analyses will be intention-to-treat. The data generated in this trial may guide a change in practice towards mechanical labour induction if this proves efficient and safer for women attempting TOLAC compared with PGE2, to improve labour management in this high-risk population.Ethics and disseminationEthical approval is granted by the Domain Specific Review Board (Domain D) of the National Healthcare Group, Singapore. All adverse events will be reported within 24 hours of notification for assessment of causality. Data will be published and will be available for future meta-analyses.Trial registration number NCT03471858; Pre-results.

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“…38,39 It is controversial if the sequential use of catheters and prostaglandins has a greater number of deliveries in first 24hours. 40,41 However, recent data suggest that with the application of Foley catheter plus oxytocin or prostaglandins an increased number of deliveries in first 24hours is achieved. [42][43][44] Regarding perinatal outcomes and related to spontaneous labour, IOL is associated with more maternal complications and worse perinatal results 45 with independence of the method used Duro-Gómez J.…”

Section: How Can Induction Of Labour Be Done?mentioning

confidence: 99%

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According to WHO, 25% of all deliveries are induced in developed countries. There are many controversies and multiple guides to induction of labour (IOL) are used in different hospitals. There are social or maternofetal indications to IOL. The way to perform the IOL depends on cervical status. Currently, prostaglandins are considered the most effective method to IOL (delivery before 24hours). Depends on each patient, it is recommended misoprostol or dinoprostone. For cases with contraindications for prostaglandins, mechanical methods (Foley catheter or double balloon intracervical catheter) are good alternatives. In any case, some special circumstances (twins' pregnancies, women with previous caesarean…) must been considered. According to perinatal outcomes, both methods are similar. Although prostaglandins are more costeffective method, women are most satisfied with mechanical methods.

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Double-balloon catheter and sequential oral misoprostol versus oral misoprostol alone for induction of labour at term: a retrospective cohort study

Cited by 15 publications

References 11 publications

Induction of labour with sequential double-balloon catheter and oral misoprostol versus oral misoprostol alone in obese women

Induction of labour with sequential double-balloon catheter and oral misoprostol versus oral misoprostol alone in obese women

MEchanical DIlatation of the Cervix in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

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Double-balloon catheter and sequential oral misoprostol versus oral misoprostol alone for induction of labour at term: a retrospective cohort study

Cited by 15 publications

References 11 publications

Induction of labour with sequential double-balloon catheter and oral misoprostol versus oral misoprostol alone in obese women

Induction of labour with sequential double-balloon catheter and oral misoprostol versus oral misoprostol alone in obese women

MEchanical DIlatation of the Cervix­­ in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

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MEchanical DIlatation of the Cervix in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery