Can a 48-Hour drug delay help babies after water breaks early?
NCT ID NCT03976063
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving nifedipine, a drug that relaxes the uterus, for 48 hours can improve health outcomes for babies when a pregnant person's water breaks too early (between 22 and 34 weeks). About 857 participants will receive either nifedipine or a placebo. The goal is to see if this short treatment reduces the risk of fetal or newborn death or severe complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nifedipine (a blood pressure medication used to relax the uterus)
- What this could lead to
- If successful, this could show that short-term use of nifedipine reduces serious complications or death in babies born after early membrane rupture.
- What could go wrong
- This is a large phase 3 trial, but tocolysis in PPROM is controversial and may not improve outcomes or could increase infection risk. Results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
857 people
The number who actually took part.
- Started
-
Oct 2019
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Trousseau University Hospital
Paris, 75012, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.