Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial
1 Department of Obstetrics K-6-P-35, Leiden University Medical Centre, P.O. Box 9600, Leiden 2300 RC, the Netherlands
2 Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
3 Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands
4 Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, the Netherlands
5 Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, the Netherlands
6 Department of Obstetrics and Gynaecology, Radboud University, Nijmegen, the Netherlands
7 Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands
8 Department of Obstetrics and Gynaecology, Kennemer Gasthuis, Haarlem, the Netherlands
9 Department of Obstetrics and Gynaecology, HAGA Hospital, Den Haag, the Netherlands
10 Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, the Netherlands
11 Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands
12 Department of Obstetrics and Gynaecology, Atrium Medical Centre, Heerlen, the Netherlands
13 Department of Obstetrics and Gynaecology, Sint Antonius Hospital, Nieuwegein, the Netherlands
14 Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, the Netherlands
15 Department of Obstetrics and Gynaecology, Sint Lucas Andreas Hospital, Amsterdam, the Netherlands
BMC Pregnancy and Childbirth 2013, 13:67 doi:10.1186/1471-2393-13-67Published: 19 March 2013
Induction 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.
We 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.
Worldwide, 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.
The Netherlands Trial Register NTR3466