Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation
Condition(s) studied
Investigational drug(s) / intervention(s)
Nifedipine: Loading dose: Oral Nifedipine 20 mg prolonged-release at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg prolonged-release at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)
Placebo of Nifedipine: Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43
Study summary
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
Eligibility
Primary outcome measure(s)
- Perinatal morti-morbidity — Up to discharge from hospital, with a maximum of 24 weeks after birth.
Composite outcome including fetal death, neonatal death and/or neonatal severe morbidity (mechanical ventilation ≥ 48 hrs, severe bronchopulmonary dysplasia, severe intraventricular hemorrhage, cystic periventricular leucomalacia, neonatal early-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Trousseau University Hospital | Paris | France |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03976063 on ClinicalTrials.gov ↗ ← All trials in France