Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
Assistance Publique - Hôpitaux de Paris
850 participants
Oct 7, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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)
- years of age or older
- French speaking
- Affiliated to social security regime or an equivalent system
- Informed consent and signed
Exclusion Criteria17
- 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)
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Interventions
Loading dose: Oral Nifedipine 20 mg prolonged-release at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg prolonged-release at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)
Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03976063