ArticlesInduction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial
Section snippets
Background
Induction of labour is an obstetric intervention that artificially initiates the process of effacement of the cervix, dilatation, uterine contractions, and eventually delivery of the baby. It aims to end the pregnancy through vaginal delivery, when continuation of the pregnancy could jeopardise the condition of the mother or her baby, and delivery ought to improve outcomes compared with continuing pregnancy. 25% of women in high-resource settings have labour induced.1, 2, 3, 4, 5 In women with
Study design and participants
We did this open-label, non-inferiority trial in six tertiary-care and 23 secondary-care hospitals collaborating in the Dutch consortium for women's health research.
We enrolled women with a vital singleton pregnancy in cephalic presentation, intact membranes, a gestational age of 37 weeks or more, and an unfavourable cervix (Bishop score <6), scheduled for induction of labour. We excluded women with known hypersensitivity to any of the products used, age younger than 18 years, a history of
Results
Between July 18, 2012, and Oct 10, 2013, we deemed 2316 women eligible, of whom 1859 consented to participate. We randomly assigned 932 women to misoprostol and 927 to Foley catheter (figure 1). 14 women were excluded from the intention-to-treat analyses, including two who did not meet the eligibility criteria: each had a history of caesarean section and no vaginal examination before randomisation. We believe that these women were enrolled by mistake by the treating physician. At the interim
Discussion
In this randomised trial, we found that, in women with an unfavourable cervix at term, induction of labour with oral misoprostol was not inferior to Foley catheter in terms of safety and effectiveness. The composite of post-partum haemorrhage and asphyxia did not occur significantly more often after induction of labour with oral misoprostol than with Foley catheter, and the individual components of the outcome were also similar. The proportion of patients who had caesarean section was similar
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Women satisfaction on choosing the cervical ripening method: Oral misoprostol versus balloon catheter
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2022, Journal of Gynecology Obstetrics and Human ReproductionAssociation between the cervical sliding sign and successful induction of labor in women with an unfavorable cervix: A prospective observational study
2022, European Journal of Obstetrics and Gynecology and Reproductive BiologyCitation Excerpt :Women who had cesarean delivery for fetal distress or reasons other than failure to progress in labor were excluded from final analysis. According to previous data [25–27], the rate of vaginal delivery within 24 h for IOL with unripe cervices (Bishop score ≤ 6) is approximately 50 %. Under the assumption of 90 % power and an alpha error of 0.05, we calculated we would need 154 patients to demonstrate a 50 % increase (from 50 % to 75 %) in the rate of the primary outcome in our study population.
Induction of labour with oral misoprostol versus vaginal misoprostol: A before-after study
2022, Gynecologie Obstetrique Fertilite et Senologie