PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes (NCT07563504) | Clinical Trial Compass
Not Yet RecruitingPhase 4
PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
Malaysia320 participantsStarted 2026-07-01
Plain-language summary
The goal of this clinical trial is to learn whether adding gentamicin to standard ampicillin prophylaxis can better prevent clinical chorioamnionitis and other maternal and neonatal infectious complications in pregnant women aged 18 years or older with singleton, cephalic, term pregnancies and confirmed prelabour rupture of membranes. The main questions it aims to answer are:
Does ampicillin plus gentamicin reduce the incidence of clinical chorioamnionitis compared with ampicillin alone? Does ampicillin plus gentamicin improve maternal infectious outcomes and neonatal infection-related outcomes compared with ampicillin alone?
Researchers will compare ampicillin alone with ampicillin plus gentamicin to see whether broader antibiotic coverage reduces maternal and neonatal infectious morbidity.
Participants will:
1. undergo screening and eligibility assessment
2. provide written informed consent before randomisation
3. be randomly assigned to receive either intravenous ampicillin alone or intravenous ampicillin plus gentamicin
4. start study antibiotics at 12 hours after membrane rupture and continue treatment until delivery
5. undergo routine maternal and fetal monitoring during labour and delivery have maternal and neonatal outcomes assessed during hospital stay and up to 42 days postpartum, including telephone follow-up at Day 14 and Day 42
6. optionally consent to placental tissue collection for microbiological culture at delivery
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clearan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Chorioamnionitis
Timeframe: From admission (diagnosis of PROM) until delivery (72 hours)