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

PHASE3RecruitingINTERVENTIONAL
Enrollment

850

Participants

Timeline

Start Date

October 7, 2019

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2030

Conditions
Preterm Premature Rupture of Membrane
Interventions
DRUG

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)

DRUG

Placebo of Nifedipine

Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43

Trial Locations (1)

75012

RECRUITING

Trousseau University Hospital, Paris

All Listed Sponsors
collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

collaborator

Ministry of Health, France

OTHER_GOV

collaborator

Groupe de Recherche en Obstétrique et Gynécologie

UNKNOWN

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03976063 - Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation | Biotech Hunter | Biotech Hunter