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Created on : 26 Nov 2017
Modified on : 05 Nov 2018

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Bibliographical entry (without author) :

Induction of labour with a Foley catheter or oral misoprostol at term: The PROBAAT-II study, a multicentre randomised controlled trial - BMC Pregnancy and Childbirth - ISBN: 14712393 (ISSN) - p.67

Author(s) :

ten Eikelder, M. L. G.; Neervoort, F.; Rengerink, K. O.; Jozwiak, M.; de Leeuw, J. W.; de Graaf, I.; van Pampus, M. G.; Franssen, M.; Oudijk, M.; van der Salm, P.; Woiski, M.; Pernet, P. J. M.; Feitsma, A. H.; van Vliet, H.; Porath, M.; Roumen, F.; van Beek, E.; Versendaal, H.; Heres, M.; Mol, B. W.; Bloemenkamp, K. W.

Year of publication :

2013

URL(s) :

https://bmcpregnancychildbirth.biomedcentral.com/a…
https://doi.org/10.1186/1471-2393-13-67

Résumé (français)  :

Abstract (English)  :

Background: 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.

Methods: 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.

Discussion: 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.Trial registration: The Netherlands Trial Register NTR3466, http://www.trialregister.nl.

Sumário (português)  :

Resumen (español)  :

Full text (public) :

Comments :

Argument (français) :

Les résultats de l’essai proposé contribueront à déterminer quelle méthode de déclenchement du travail est la plus sûre, la plus rentable et la plus adaptée aux patients, et aideront à élaborer des règles de bonne pratique fondées sur des données probantes.

Argument (English):

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.

Argumento (português):

Os resultados do estudo proposto ajudarão a determinar o método mais seguro, mais eficaz em termos de custo e amigável ao paciente para iniciar o trabalho e ajudarão a desenvolver regras de boas práticas baseadas em evidências.

Argumento (español):

Keywords :

➡ misoprostol (Cytotec)

Author of this record :

Import 26/11/2017 — 26 Nov 2017
➡ latest update : Bernard Bel — 05 Nov 2018