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

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Groupe de Recherche en Obstétrique et Gynécologie; INSERM U1153; Ministry of Health, France
• Treatments: Nifedipine

Criteria

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 cellulos

• Coadministration of diltiazem or rifampicine

• Hypotension (systolic pressure < 90 mmHg)

• Participation to another interventional research (category 1)