Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation (NCT03976063) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation
France857 participantsStarted 2019-10-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria:
* 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)
What they're measuring
1
Perinatal morti-morbidity
Timeframe: Up to discharge from hospital, with a maximum of 24 weeks after birth.