{"title":"Results of the RE-DINO multicenter randomized trial on the repeated use of vaginal dinoprostone (Propess®) for labor induction in patients at term","authors":"Perrine Coste-Mazeau MD, PhD , Denis Gallot , François Siegerth MD , Angeline Garuchet-Bigot MD , Emmanuel Decroisette MD , Julie Blanc , Muriel Cantaloube MD , Sabrina Crépin Pharm D , Julien Magne , Anais Labrunie MS , Renaud Martin PhD , Miassa Hessas MD","doi":"10.1016/j.ajogmf.2024.101510","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Labor is induced in over 25% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 hours, 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.</div></div><div><h3>Objectives</h3><div>Our principal objective was to determine whether placement of a second Propess®, followed by oxytocin (Syntocinon®) if necessary, in pregnant 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 was therefore the primary outcome. The secondary outcomes were the cervical ripening failure rate and maternal and fetal morbidity and mortality.</div></div><div><h3>Study Design</h3><div>RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with 2 parallel arms running in 7 French hospitals. Patients at > 37 weeks of gestation who had unfavorable cervical conditions (Bishop score < 6) 24 hours after placement of the first Propess® (vaginal patch featuring progressive continuous diffusion of 10 mg dinoprostone), with fetuses in cephalic presentation, were included.</div></div><div><h3>Results</h3><div>160 pregnant women were randomized, 80 patients in each group, from December 2016 through April 2022. Baseline characteristics such as age, BMI, maternal age at induction and Bishop score at induction were similar between both groups. Vaginal delivery occurred in 76.3% of cases in the 2nd Propess® group and 73.8% of cases in the Syntocinon® group (RR=1.03 [0.86; 1.24], <em>p</em>=.715). Although the cesarean section rate was similar in each group, there were significantly more cesarean sections for arrest of dilatation (52.6% vs 19%; <em>p</em>=.0262) in the Propess® group and a larger, borderline-significant difference in patients having operative vaginal delivery (24.6% vs 11.9%; <em>p</em>=.07) for abnormal fetal heart rate (80% vs 29%; <em>p</em>=.05). There was significantly more failure of cervical ripening in the Propess® group (57.1% vs 19%; RR=2.59 ; 95% CI [1.64; 4.11]; <em>p</em><.0001) and the interval between study treatment and delivery was also significantly longer (28.1h vs 9,7h; <em>p</em><.0001). There was a higher incidence of postpartum hemorrhage in the Propess® group, although this was not significant (11.3% vs 5% ; <em>p</em>=,15), but also more newborns with acidosis (39.3% vs 27.9% ; <em>p</em>=.18) or severe acidosis (8,6% vs 3.4% ; <em>p</em>=.27), more meconium fluid (11.3% vs 6.3% ; <em>p</em>=.26) and transferred to intensive care (5% vs 2.5% ; <em>p</em>=.68).</div></div><div><h3>Conclusion</h3><div>Our data showed no superiority of a second dinoprostone pessary over oxytocin in patients not responding to initial prostaglandins E2 maturation for labor induction. Repeated use of Propess® is not useful for induction of labor.</div></div>","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"6 11","pages":"Article 101510"},"PeriodicalIF":3.8000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Obstetrics & Gynecology Mfm","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2589933324002362","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Labor is induced in over 25% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 hours, 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.
Objectives
Our principal objective was to determine whether placement of a second Propess®, followed by oxytocin (Syntocinon®) if necessary, in pregnant 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 was therefore the primary outcome. The secondary outcomes were the cervical ripening failure rate and maternal and fetal morbidity and mortality.
Study Design
RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with 2 parallel arms running in 7 French hospitals. Patients at > 37 weeks of gestation who had unfavorable cervical conditions (Bishop score < 6) 24 hours after placement of the first Propess® (vaginal patch featuring progressive continuous diffusion of 10 mg dinoprostone), with fetuses in cephalic presentation, were included.
Results
160 pregnant women were randomized, 80 patients in each group, from December 2016 through April 2022. Baseline characteristics such as age, BMI, maternal age at induction and Bishop score at induction were similar between both groups. Vaginal delivery occurred in 76.3% of cases in the 2nd Propess® group and 73.8% of cases in the Syntocinon® group (RR=1.03 [0.86; 1.24], p=.715). Although the cesarean section rate was similar in each group, there were significantly more cesarean sections for arrest of dilatation (52.6% vs 19%; p=.0262) in the Propess® group and a larger, borderline-significant difference in patients having operative vaginal delivery (24.6% vs 11.9%; p=.07) for abnormal fetal heart rate (80% vs 29%; p=.05). There was significantly more failure of cervical ripening in the Propess® group (57.1% vs 19%; RR=2.59 ; 95% CI [1.64; 4.11]; p<.0001) and the interval between study treatment and delivery was also significantly longer (28.1h vs 9,7h; p<.0001). There was a higher incidence of postpartum hemorrhage in the Propess® group, although this was not significant (11.3% vs 5% ; p=,15), but also more newborns with acidosis (39.3% vs 27.9% ; p=.18) or severe acidosis (8,6% vs 3.4% ; p=.27), more meconium fluid (11.3% vs 6.3% ; p=.26) and transferred to intensive care (5% vs 2.5% ; p=.68).
Conclusion
Our data showed no superiority of a second dinoprostone pessary over oxytocin in patients not responding to initial prostaglandins E2 maturation for labor induction. Repeated use of Propess® is not useful for induction of labor.
期刊介绍:
The American Journal of Obstetrics and Gynecology (AJOG) is a highly esteemed publication with two companion titles. One of these is the American Journal of Obstetrics and Gynecology Maternal-Fetal Medicine (AJOG MFM), which is dedicated to the latest research in the field of maternal-fetal medicine, specifically concerning high-risk pregnancies. The journal encompasses a wide range of topics, including:
Maternal Complications: It addresses significant studies that have the potential to change clinical practice regarding complications faced by pregnant women.
Fetal Complications: The journal covers prenatal diagnosis, ultrasound, and genetic issues related to the fetus, providing insights into the management and care of fetal health.
Prenatal Care: It discusses the best practices in prenatal care to ensure the health and well-being of both the mother and the unborn child.
Intrapartum Care: It provides guidance on the care provided during the childbirth process, which is critical for the safety of both mother and baby.
Postpartum Issues: The journal also tackles issues that arise after childbirth, focusing on the postpartum period and its implications for maternal health. AJOG MFM serves as a reliable forum for peer-reviewed research, with a preference for randomized trials and meta-analyses. The goal is to equip researchers and clinicians with the most current information and evidence-based strategies to effectively manage high-risk pregnancies and to provide the best possible care for mothers and their unborn children.