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
Conditions
Interventions
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
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Prematurity (<37 weeks) 2. GBS positive vagino-rectal swab or with an unknown swab 3. Multiple pregnancies 4. Previous cesarean section (CS) 5. Breech presentation, transverse lie or other indication for elective CS 6. Suspected clinic for intra-amniotic infection 7. Stained amniotic fluid 8. Alterations of the FHR 9. Unknown exact ROM time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;Primary end point(s): The reduction of maternal/neonatal infectious morbidity through the active management of labor;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactClinical Trial Quality Team
Servizio Formazione, Ricerca e Innovazione
Outcome results
None listed