Preterm Rupture of Membranes Optimising Antibiotics Trial

Launched by UNIVERSITY OF MELBOURNE · Mar 31, 2025

Keywords

ClinConnect Summary

The Preterm Rupture of Membranes Optimising Antibiotics Trial, or PROMOAT, is a study designed to find out which type of antibiotics works best to prevent infection in pregnant women whose water has broken early, a condition known as preterm pre-labour rupture of membranes (PPROM). The goal is to see how these antibiotics can help the health of both the mothers and their babies. Researchers will compare three different antibiotic treatments that are already being used in hospitals. If you are a pregnant woman who is less than 37 weeks along and your water has broken, you may be eligible to join this trial.

Participants in the study will be randomly assigned to one of the antibiotic treatments, which they will take for seven days or until their baby is born, whichever comes first. All the antibiotics will be taken by mouth. Throughout the trial, researchers will check on the health of the babies at 42 weeks after their due date and gather information about the mothers’ health and mood both at the start of the study and about six weeks after giving birth. This important research aims to improve care for mothers and babies in similar situations in the future.

Gender

FEMALE

Eligibility criteria

• • PLATFORM ELIGIBILITY
• Participants must meet all core PLATIPUS platform inclusion criteria:
• • Considered to be at risk of birth before 37 weeks gestation (spontaneous and provider-initiated)
• • Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and
• • Meet eligibility criteria for one or more platform domains.
• Participants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:
• • Inability to consent for themselves
• • Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).
• • Pregnant women and people who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for PROMOAT-specific eligibility.
• • PROMOAT-SPECIFIC ELIGIBILITY
• Platform-eligible participants must meet all PROMOAT-specific inclusion criteria:
• 1. Women with singleton or multiple pregnancies complicated by preterm prelabour rupture of membranes (PPROM) \< 37+0 weeks' gestation as determined by the treating clinician and standard criteria:
• • Maternal history consistent with loss of fluid per vagina
• • Evidence of a pool of fluid in the vagina on sterile speculum examination
• • +/- positive testing for IGFBP-1 (Actim PROM) or PAMG-1 (Amnisure) AND
• • 2. Are eligible for at least two treatment arms within the domain
• • 3. The fetus/fetuses are alive at randomisation
• • 4. The pregnancy is continuing and active neonatal management is planned.
• Participants will be excluded from participation if they meet core PLATIPUS platform exclusion criteria:
• • Inability to consent for themselves OR
• • Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).
• Participants will be excluded from participation if they meet any PROMOAT-specific exclusion criteria:
• • 1. Antibiotic treatment for \> 24 hours administered with the aim of preventing infection from PPROM
• • 2. Suspected maternal or fetal infection (chorioamnionitis)
• • 3. Maternal or fetal indication for immediate birth
• • 4. Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)
• • 5. No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection/s
• • 6. Women with a previous infant affected by GBS sepsis
• • 7. Major congenital fetal anomaly.
• • Platform-eligible participants who meet all PROMOAT-specific inclusion criteria and none of the PROMOAT-specific exclusion criteria will be eligible to participate in PROMOAT.