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PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
Sponsor: Sarawak General Hospital
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
Official title: Term Prelabour Rupture of Membranes Antibiotic Prophylaxis (PROMab) Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2026-07-01
Completion Date
2027-03-31
Last Updated
2026-05-04
Healthy Volunteers
No
Interventions
Ampicillin
Intravenous ampicillin 2 g stat, followed by 1 g every 4 hours, initiated at 12 hours after prelabour rupture of membranes and continued until delivery.
Ampicillin + gentamicin
Intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours, plus intravenous gentamicin 5 mg/kg once daily. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. Gentamicin will only be administered to participants with baseline creatinine clearance of 30 mL/min or higher.
Locations (3)
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Miri Hospital
Miri, Sarawak, Malaysia
Sarikei Hospital
Sarikei, Sarawak, Malaysia