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PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes

NCT07563504 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-05-04

No results posted yet for this study

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

Conditions

  • Rupture of Membranes Prior to Onset of Labor

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Sarawak General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-01-31
Completion
2027-03-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563504 on ClinicalTrials.gov