Using Nifedipine to manage preterm premature rupture of membranes
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
This study tests if using Nifedipine can help pregnant women with early water breaking stay pregnant longer to improve the health of their babies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT03976063 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of short-term tocolysis using Nifedipine in reducing perinatal morbidity and mortality in cases of preterm premature rupture of membranes (PPROM) occurring between 22 and 33 weeks of gestation. The research aims to determine if delaying delivery through tocolysis can improve neonatal outcomes by allowing for the administration of corticosteroids. Participants will be randomly assigned to receive either Nifedipine or a placebo for a duration of 48 hours. The study is conducted under strict eligibility criteria to ensure the safety and appropriateness of the intervention for the participants.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 and older with singleton gestation diagnosed with PPROM between 22 and 33 weeks of gestation.
Not a fit: Patients with contraindications to tocolysis, such as chorioamnionitis or significant fetal distress, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve neonatal outcomes for infants born to mothers experiencing PPROM.
How similar studies have performed: While the use of tocolysis in PPROM is not widely recommended, similar studies have explored its potential benefits, indicating a need for further investigation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Paris
- Trousseau University Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Gilles Kayem, MD, PhD — INSERM UMR 1153, Obstetrical, Perinatal and PEdiatric Epidemiology (EPOPé) Research Team, Center of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital
- Study coordinator: Gilles Kayem, MD, PhD
- Email: gilles.kayem@aphp.fr
- Phone: 00 33 1 44 73 51 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.