PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial

INTERVENTION: Product Name: DINOPROSTONE Product Code: [‐] Pharmaceutical Form: Vaginal gel Current Sponsor code: ‐ Other descriptive name: dinoprostone Concentration unit: mg/g milligram(s)/gram Concentration type: up to Concentration number: 2‐ Product Name: dinoprostone Product Code: [‐] Pharmaceutical Form: Vaginal delivery system Current Sponsor code: ‐ Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Product Name: ossitocina Product Code: [‐] Pharmaceutical Form: Solution for injection Current Sponsor code: ‐ Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 5‐ Product Name: misoprostolo Product Code: [‐] Pharmaceutical Form: Tablet Current Sponsor code: ‐ Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 25‐ CONDITION: 1400 Women with PROM at term and a GBS negative swab ; MedDRA version: 20.0 Level: PT Classification code 10073024 Term: Preterm premature rupture of membranes System Organ Class: 10036585 ‐ Pregnancy, puerperium and perinatal conditions Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: The first objective of this study is to evaluate whether active management of women with PROM (early induction) reduces the newborn need of respiratory support. Primary end point(s): The reduction of maternal/neonatal infectious morbidity through the active management of labor Secondary Objective: To evaluate the changes in the neonatal meconium microbiome and to assess the placental and umbilical cord histology in both the study arms. Timepoint(s) of evaluation of this end point: The primary end point will be evaluated through the measurement of the rate of chorioamnionitis diagnosis (according to the Triple I) during labor (visit 1), the need for antibiotic treatment for the mother and the neonate (visit 1, 2 and follow up at 48 hours post‐partum), and the rate of ventilatory support measures carried out on the neonate after birth (visit 2). SECONDARY OUTCOME: Secondary end point(s): The secondary objectives of this study are related to the safety of the active management assessed through the rate of stillbirths, the onset of infections in the mother and fetus and through the length of hospitalization of both the mother and the fetus. Timepoint(s) of evaluation of this end point: Labor, visits and follow up INCLUSION CRITERIA: 1. Gestational age = 37 weeks 2. Negative rectovaginal GBS swab 3. Absent/poor uterine contractile activity 6 h after PROM (0‐2 contractions /10 min) 4. Cephalic presentation 5. Age =18 years of age at the time of randomization 6. Ability to provide an informed consent 7. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 1400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range