What is the optimal antibiotic regimen for women with premature, prelabour rupture of membranes (PPROM)?
Objective
To determine which antibiotic regimen given to pregnant women with preterm prelabour rupture of membranes (PPROM) is best at improving health outcomes for preterm infants.
Who will be eligible?
Pregnant women with preterm, prelabour rupture of membranes (PPROM) who meet the eligibility criteria and are receiving care at a hospital taking part in this trial.
Why is this important?
Preterm prelabour rupture of membranes (PPROM) is when a pregnant woman’s waters break early. Approximately 30-40% of women who go on to have a preterm birth experience PPROM. PPROM can lead to infections and other complications in mother and baby.
Antibiotics are routinely given to pregnant women who experience PPROM to reduce the risk of infection.
Why are we doing this study?
The antibiotics given after PPROM vary in Australia, Aotearoa New Zealand and worldwide. Evidence for some of these antibiotics is now quite old, and there is potential in other antibiotics that are already being used for this purpose.
PROMOAT will assess three common antibiotic regimens given after PPROM, to reduce uncertainty and understand which antibiotic is best in reducing the risk of infection in mother and baby.
Funding: NHMRC GNT2032384; MRFF GNT2031127
Ethics Reference: HREC/111728/RCHM-2025
Trial Registration: NCT06906757
A/Prof. Clare Whitehead
Chair, Associate Professor of Maternal and Perinatal Health, Pregnancy Lead (AUS)
Prof. Katie Groom
Professor of Maternal and Perinatal Health, Pregnancy Lead (NZ)
Dr Lisa Dawes
Maternal Fetal Subspecialist
Prof. Joshua Vogel
Professor of Perinatal Epidemiology
Prof. John Newnham
Professor of Obstetrics
Prof. Michelle Giles
Professor of Infectious Disease (Adults)
Prof. Steven Tong
Professor of Infectious Disease (Adults)
Dr Lesley Voss
Infectious Disease Specialist (Paediatrics)
Prof. Michael Stark
Professor of Neonatal Medicine
Prof. Brett Manley
Professor of Neonatal Medicine, Neonatal Lead (AUS)
Dr Matthew Payne
Perinatal Molecular Microbiologist
Prof. Katherine Lee
Professor of Biostatistics
Dr Robert Mahar
Biostatistician
Rebecca Streith
Lived Experience Consultant
Platform for Adaptive Trials in Perinatal Units