Ireland
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Active, not recruiting Phase 3

Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation

NCT03976063 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2019-10-07
Last updated
2026-04-23

Condition(s) studied

Preterm Premature Rupture of Membrane

Investigational drug(s) / intervention(s)

Nifedipine →Placebo of Nifedipine

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team * Singleton gestation * Fetus alive at the time of randomization (reassuring fetal heart monitoring) * 18 years of age or older * French speaking * Affiliated to social security regime or an equivalent system * Informed consent and signed Exclusion Criteria: * PPROM ≥ 24 hours before diagnosis * Ongoing tocolytic treatment at the time of PPROM * Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization * Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization * Cervical dilation \> 5 cm * Iatrogenic rupture caused by amniocentesis or trophoblast biopsy * Major fetal anomaly * Maternal allergy or contra-indication to Nifedipine or placebo drug components\*: * Myocardial infarction * Unstable angina pectoris * Hepatic insufficiency * Cardiovascular shock * Beta blockers placebo drug components: lactose monohydrate, colloidal silica, microcrystalline cellulose * Coadministration of diltiazem or rifampicin * Hypotension (systolic pressure \< 90 mmHg) * Participation to another interventional research (category 1) in which intervention could interfere with TOCOPROM's results (efficacy and safety)

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)

FacilityCityRegionStatus
Trousseau University Hospital Paris France
Official registry record

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