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).
Subject(s)
Dinoprostone/administration & dosage , Labor, Induced , Oxytocics/administration & dosage , Oxytocin/administration & dosage , Administration, Intravaginal , Adult , Cervical Ripening/drug effects , Clinical Trials, Phase III as Topic , Equivalence Trials as Topic , Female , France , Humans , Infusions, Intravenous , Multicenter Studies as Topic , Pregnancy , Randomized Controlled Trials as Topic , Retreatment/methods , Treatment Outcome , Young AdultABSTRACT
OBJECTIVE: To provide clinical practice guidelines from the French college of obstetrics and gynecology (CNGOF) with the Haute Autorité de santé (HAS), based on the best evidence available, concerning the diagnosis accuracy of endoscopy (laparoscopy, hysteroscopy, fertiloscopy, cystoscopy, colonoscopy) in case of endometriosis. MATERIAL AND METHODS: English and French review of literature about the diagnosis accuracy of endoscopy in case of endometriosis. RESULTS AND CONCLUSION: Laparoscopy is useful in case of suspected endometriosis in patients with symptoms or infertility when appropriate preoperative assessment is negative (grade C). Biopsies during diagnosis laparoscopy are recommended in case of typical or atypical lesions to confirm endometriosis (grade B). It is not recommended to perform fertiloscopy in case of suspected endometriosis (grade C). Hysteroscopy could be performed in case of suspected endometriosis and infertility to eliminate endometrial polyp or septate uterus (grade C). Colonoscopy is not recommended in case of suspected deep posterior endometriosis (grade C).
