This research aims to improve the future of mothers and children facing the opening of the water pouch (or rupture of membranes) occurred prematurely before the 8th month of pregnancy. Premature rupture of the membranes before the 8th month of pregnancy exposes to a high risk of premature delivery. A drug called tocolysis will be prescribed to reduce uterine contractions and delay the risk of preterm birth

Phase 1

Conditions: Pregnant women with PPROM at 22 to 33 weeks gestation
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2018-004482-14-FR

Lead Sponsor: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 850

Inclusion Criteria

Preterm premature rupture of membranes (PPROM) between 22 0/7 - 33 6/7 weeks of gestation, as diagnosed by obstetric teams: the diagnosis is usually based on 2 positive criteria from maternal history, sterile speculum examination to confirm fluid leakage from the cervical canal and performance of a diagnostic test.
- Singleton gestation
- Fetus alive at the time of randomization
- 18 years of age or older
- French speaking
- Affiliated to social security or an equivalent system
- Informed consent and signed

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 850
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- PPROM = 24 hrs before diagnosis
- Ongoing tocolytic treatment at the time of PPROM
- Any tocolytic treatment between PPROM diagnosis and randomization
- Fetal condition contraindicating expectant management including chorioamnionitis, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
- Cervical dilation > 5 cm
- Iatrogenic rupture following amniocentesis (<5 weeks after amniocentesis)
- 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
- Coadministration of diltiazem or rifampicine
- Hypotension (systolic blood pressure < 90 mmHg)
-Participation to another interventional study