Tocolysis in cases of preterm premature rupture of membranes (PPROM) before 34 weeks of gestation: a double-blinded randomized controlled trial.

Phase 1

• Conditions: obstetric_pathological delivery; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2024-512872-36-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-10
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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

Exclusion Criteria

- PPROM = 24 hrs 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, haemorrhagic placenta praevia, 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 - Cardiopathy - Co-administration of diltiazem, rifampicine, transdermal nitrates or any antihypertensive medication - Hypotension (systolic blood pressure < 90 mmHg) - Participation to another interventional research (category 1) in which intervention could interfere with Tocoprom’s results (efficacy and safety).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks’ gestation.;Secondary Objective: To assess the impact of 48 hours tocolysis in cases of PPROM at 22 to 33 weeks’ gestation on latency duration, maternal morbidity and neonatal minor morbidity.;Primary end point(s): The primary endpoint is a composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Prolongation of gestation -Maternal morbidity -Neonatal minor morbidity -Outcomes at 2 years of corrected age