Can a 48-Hour drug delay help babies after water breaks early?
NCT ID NCT03976063
First seen Nov 20, 2025 · Last updated Jun 23, 2026 · Updated 30 times
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.
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Trousseau University Hospital
Paris, 75012, France
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.
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.