TOCOPROM - Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation:a double-blinded randomized controlled trial - P160917

Assistance Publique Hopitaux De Paris0 个研究点目标入组 850 人开始时间: 2024年6月10日最近更新: 2024年8月21日

适应症

试验速览

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•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

•- 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).

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