Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial

Abstract

BackgroundInduction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness.Methods/DesignWe plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women’s preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome.DiscussionWorldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines.Trial registrationThe Netherlands Trial Register NTR3466

Comparing induction of labour with oral misoprostol or Foley catheter at term: cost‐effectiveness analysis of a randomised controlled multi‐centre non‐inferiority trial

“…2011_010#B2012219), and by the boards of directors of all participating hospitals. The study protocol can be accessed online . The study was conducted in six tertiary and 23 secondary care hospitals in the Netherlands.…”

Intracervical Foley Catheter Plus Intravaginal Misoprostol vs Intravaginal Misoprostol Alone for Cervical Ripening: A Meta-Analysis

“…Pharmacological methods include many agents, such as PG (PGE2 or PGE1), progesterone receptor antagonists (mifepristone), oxytocin, and nitric oxide (NO) donors, but the most commonly used are prostaglandins and oxytocin. Misoprostol is a synthetic PGE1 analog and is used frequently, because of low cost and easy preservation (refrigeration is not needed), although it is not licensed for labor induction [6,10,19,39,40]. It achieves cervical softening through disintegration and dissolution of extracellular collagen [41].…”

Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term

“…9 In short, the trial was a multicenter open-label randomized controlled trial studying women with a viable singleton pregnancy beyond 37 weeks of gestation, scheduled for induction of labor, with an unfavorable cervix (Bishop score < 6) and without a previous cesarean section. The study compared induction of labor with oral misoprostol to Foley catheter.…”

“…The study showed that induction with oral misoprostol was comparable to Foley catheter in terms of safety and effectiveness. 9 With a comparable safety and effectiveness profile, women's experiences and preferences will become increasingly important.…”

“…8 In women with an unripe cervix requiring induction of labor, both oral misoprostol and the Foley catheter are safer than vaginal prostaglandins. [6][7][8][9] Our recent PRO-BAAT-II trial compared induction of labor with 50-µg oral misoprostol to 30-mL transcervical Foley catheter in women with an unfavorable cervix at term. The study showed that induction with oral misoprostol was comparable to Foley catheter in terms of safety and effectiveness.…”