Author:
Coste Mazeau P.,Hessas M.,Martin R.,Eyraud J.-L.,Margueritte F.,Aubard Y.,Sallee C.,Sire F.,Gauthier T.
Abstract
Abstract
Background
Labor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 h, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery.
Methods
RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with two parallel arms running in six French hospitals. A total of 360 patients ≥ 18 years of age at > 37 weeks of gestation who exhibit unfavorable cervical conditions (Bishop score < 6) 24 h after placement of the first Propess®, with fetuses in cephalic presentation, will be included. Patients with premature membrane rupture, uterine scars, or multiple pregnancies will be excluded. Our principal objective is to determine whether placement of a second Propess® (followed by oxytocin [Syntocinon®], if necessary) in women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate is therefore the primary outcome. The secondary outcomes are the induction failure rates and maternofetal morbidity and mortality.
Discussion
This study may help in determining the optimal way to induce labor after failure of a first Propess®, an unresolved problem to date. This trial explores the effectiveness and safety of placing a second Propess® and may contribute to development of an obstetric consensus.
Trial registration
Registered on 2 September 2016 at clinicaltrials.gov (identification number NCT02888041).
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference32 articles.
1. Recommandations professionnelles de la Haute Autorité de Santé. Déclenchement artificiel du travail à partir de 37 semaines d'amenorrhee. Rev Sage-Femme. 2009;8(1):53-6.
2. Blondel B, Lelong N, Kermarrec M, Goffinet F. La santé périnatale en France métropolitaine de 1995 à 2010. Résultats des enquêtes nationales périnatales. J Gynécologie Obstétrique Biol Reprod. 2012;41(2):151–66.
3. Goffinet F, Humbert R, Clerson P, Philippe HJ, Bréart G, Cabrol D. National survey on the use of induced labor by obstetricians. Study group on induced labor. J Gynecol Obstet Biol Reprod (Paris). 1999;28(4):319–29.
4. Blanc-Petitjean P, Salomé M, Dupont C, Crenn-Hebert C, Gaudineau A, Perrotte F, et al. Labor induction practices in France: a population-based declarative survey in 94 maternity units. J Gynecol Obstet Hum Reprod. 2018;47(2):57–62.
5. Shirley M. Dinoprostone vaginal insert: a review in cervical ripening. Drugs. 2018;78(15):1615–24.
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