Could a Two-Antibiotic cocktail prevent infections after water breaks?
NCT ID NCT07563504
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether giving two antibiotics (ampicillin and gentamicin) instead of one (ampicillin alone) can better prevent infections in pregnant women whose water breaks before labor starts. About 320 women at term will be randomly assigned to one of the two treatments. The goal is to reduce chorioamnionitis (a serious infection of the amniotic sac) and other complications for both mother and baby.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ampicillin and gentamicin (antibiotics)
- What this could lead to
- If successful, this could show that adding gentamicin to standard care reduces serious infections in mothers and newborns after membrane rupture.
- What could go wrong
- This is a single-center trial with 320 participants, so results may not apply broadly. Gentamicin carries risks of kidney and hearing issues, though these are monitored.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
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: * Age 18 years or older * Singleton pregnancy * Cephalic (vertex) presentation * Term gestation of 37+0 weeks or more based on obstetric dating * Confirmed prelabour rupture of membranes * Duration of prelabour rupture of membranes 12 hours or less at the time of enrolment * Unknown or negative Group B Streptococcus status in the current pregnancy * Clear amniotic fluid at presentation * Afebrile with no clinical signs of intra-amniotic infection at admission * Able to provide written informed consent * Planned delivery at a participating study hospital Exclusion Criteria: * Preterm prelabour rupture of membranes before 37+0 weeks * Fever of 38.0°C or higher, maternal tachycardia, uterine tenderness, purulent discharge, or other clinical suspicion of infection at admission * Antibiotics already initiated in the current episode of care for any reason * Receipt of systemic antibiotics in the past 7 days * Meconium-stained liquor at presentation * Contraindication to vaginal delivery, including malpresentation, major placenta praevia, maternal refusal of trial of labour after caesarean, or known absolute indication for elective lower segment caesarean section * Known Group B Streptococcus colonisation in the current pregnancy, including positive rectovaginal swab or bacteriuria * Abnormal cardiotocography on admission requiring expedited delivery * Allergy or contraindication to penicillin or aminoglycosides * Renal impairment defined as creatinine clearance less than 30 mL/min * Known renal disease * Known ototoxicity risk or vestibular/cochlear disorders * Unknown timing of prelabour rupture of membranes * Multiple gestation * Major fetal anomaly
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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
3 sites. 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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Miri Hospital
Miri, Sarawak, 98000, Malaysia
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Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
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Sarikei Hospital
Sarikei, Sarawak, 96100, Malaysia
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