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.
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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
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Trousseau University Hospital
Paris, 75012, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.