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Tocolysis in cases of preterm premature rupture of membranes (PPROM) before 34 weeks of gestation: a double-blinded randomized controlled trial.
EU CTIS ID: 2024-512872-36-00
What this study is testing
To assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks’ gestation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.