Is there an interest in repeating the vaginal administration of dinoprostone (Propess®), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial

P Coste Mazeau, M Hessas, R Martin, J-L Eyraud, F Margueritte, Y Aubard, C Sallee, F Sire, T Gauthier, P Coste Mazeau, M Hessas, R Martin, J-L Eyraud, F Margueritte, Y Aubard, C Sallee, F Sire, T Gauthier

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).

Keywords: Dinoprostone; Induction of labor; Oxytocin; Pregnancy.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure. Schedule Of Enrolment, Interventions, And Assessments. ** H = hours; D = days. AE = adverse events / SAE = serious adverse events. 1 Complete blood counts, blood coagulation and search of irregular agglutinin. 2 By the midwife

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