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).

中文翻译：

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是否有兴趣重复阴道给药地诺前列酮 (Propess®) 以促进足月孕妇的引产？(RE-DINO)：随机对照试验的研究方案。

背景技术 在法国，超过 20% 的女性接受了引产。前列腺素，尤其是阴道内注射地诺前列酮 (Propess®)，广泛用于促进宫颈成熟。如果 24 小时内未开始临产，则不确定是否要给予第二次地诺前列酮子宫托或使用催产素引产以实现阴道分娩。方法 RE-DINO 是一项前瞻性、开放标签、多中心、随机优势试验，在法国六家医院进行了两个平行试验。总共 360 名年龄≥ 18 岁、妊娠 > 37 周、在放置第一个 Propess® 后 24 小时表现出不良宫颈状况（Bishop 评分 < 6）且胎儿呈头位的患者将被纳入研究。胎膜早破、子宫疤痕或多胎妊娠的患者将被排除。我们的主要目标是确定对于第一次 Propess® 未能诱导宫颈成熟的女性，与直接注射催产素相比，放置第二次 Propess®（如有必要，随后注射催产素 [Syntocinon®]）是否会提高阴道分娩率。因此，阴道分娩率是主要结果。次要结局是引产失败率以及母胎发病率和死亡率。讨论 这项研究可能有助于确定第一次 Propess® 失败后引产的最佳方式，这是迄今为止尚未解决的问题。该试验探讨了放置第二个 Propess® 的有效性和安全性，并可能有助于达成产科共识。试验注册于 2016 年 9 月 2 日在 ClinicalTrials.gov 注册（识别号 NCT02888041）。