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

ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 850 人开始时间: 2019年7月3日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 850
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- PPROM = 24 hrs before diagnosis
•- Ongoing tocolytic treatment at the time of PPROM
•- Any tocolytic treatment between PPROM diagnosis and randomization
•- Fetal condition contraindicating expectant management including chorioamnionitis, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
•- Cervical dilation > 5 cm
•- Iatrogenic rupture following amniocentesis (<5 weeks after amniocentesis)
•- 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
•- Coadministration of diltiazem or rifampicine
•- Hypotension (systolic blood pressure < 90 mmHg)
•-Participation to another interventional study

发起方

ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)