2024-512872-36-00招募中3 期
TOCOPROM - Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation: a double-blinded randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 21
- 主要终点
- The primary endpoint is a composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity.
研究概览
简要总结
To assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks’ gestation.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
The primary endpoint is a composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity.
The primary endpoint is a composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity.
次要结局
- Prolongation of gestation - Maternal morbidity - Neonatal minor morbidity - Outcomes at 2 years of corrected age
研究者
Pr Gilles KAYEM
Scientific
Assistance Publique Hopitaux De Paris
研究点 (21)
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