Informations générales (source: ClinicalTrials.gov)
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2019
novembre 2030
29 août 2025
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces
perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
Etablissements
Critères
Femme
Inclusion Criteria:
- Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of
gestation, as diagnosed by obstetric team
- Singleton gestation
- Fetus alive at the time of randomization (reassuring fetal heart monitoring)
- 18 years of age or older
- French speaking
- Affiliated to social security regime or an equivalent system
- Informed consent and signed
- Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of
gestation, as diagnosed by obstetric team
- Singleton gestation
- Fetus alive at the time of randomization (reassuring fetal heart monitoring)
- 18 years of age or older
- French speaking
- Affiliated to social security regime or an equivalent system
- Informed consent and signed
- PPROM ≥ 24 hours 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, 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
placebo drug components: lactose monohydrate, colloidal silica, microcrystalline
cellulose
- Coadministration of diltiazem or rifampicin
- Hypotension (systolic pressure < 90 mmHg)
- Participation to another interventional research (category 1) in which intervention
could interfere with TOCOPROM's results (efficacy and safety)