Could a cocktail of antibiotics save babies born too early?
NCT ID NCT06572761
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a combination of three antibiotics to pregnant women who show signs of very early labour (between 18 and 23 weeks) can help prolong the pregnancy and reduce the risk of death or serious health problems for the baby. About 350 participants will be randomly assigned to receive either the antibiotics or standard care. The goal is to see if this treatment can improve survival and lower complications like lung disease, severe bleeding in the brain, or serious gut infections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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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: * Threatened previable prelabor with intact membranes between 18weeks of gestation +0/7 and 23 weeks of gestation 6/7 SA defined on endovaginal ultrasound by a short cervix ≤10 mm, and/or protrusion of the membranes on speculum examination. * Maternal age \>18 years * Affiliated with social security * Correct understanding of the French language * Singleton pregnancy * Foetus alive at time of inclusion * Absence of regular and painful uterine contractions Exclusion Criteria: * Premature labor defined by regular, painful uterine contractions and a short cervix * Protected person (patient under guardianship/curatorship/or legal protection) * Multiple pregnancies * Premature rupture of membranes * Acute chorioamnionitis * Contraindication to protocol antibiotics * Chromosomal abnormality, congenital malformation * Patients who received antibiotics before randomization, or requiring antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.) * Participation in another research (Specify the category: RIPH, EC, IC, etc.) or being in the exclusion period following previous research involving humans, if applicable * Patient under AME (if no exemption from affiliation)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier Poissy-Saint Germain
Poissy, 78300, France