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ClinicalTrials.gov ID

NCT07563504

Lead Sponsor

Sarawak General HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

320Estimated

Last Update Posted

May 4, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

Mar 31, 2027Estimated

Official Title

Term Prelabour Rupture of Membranes Antibiotic Prophylaxis (PROMab) Trial

Brief 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

• Rupture of Membranes Prior to Onset of Labor

• Ampicillin
• Ampicillin + gentamicin

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Sarawak General HospitalOTHER

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