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 and people with preterm prelabour rupture of membranes (PPROM) is best at improving health outcomes for preterm infants.
Who will be eligible?
Pregnant women and people 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 or person’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 and people 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
Assoc. Prof. Clare Whitehead
Chair, Maternal and Fetal Medicine Specialist
Prof. Katie Groom
PLATIPUS Lead (NZ); Maternal Fetal Subspecialist
Dr Lisa Dawes
Maternal Fetal Subspecialist
Prof. Joshua Vogel
Perinatal Epidemiologist
Prof. John Newnham
Professor, Obstetrics
Prof. Michelle Giles
Professor, Infectious Disease (Adults)
Prof. Steven Tong
Professor, Infectious Disease (Adults)
Dr Lesley Voss
Infectious Disease (Paediatrics)
Prof. Michael Stark
Neonatologist
Prof. Brett Manley
Professor, Neonatology
Dr Matthew Payne
Perinatal molecular microbiologist
Prof. Katherine Lee
Biostatistician
Dr Robert Mahar
Biostatistician
Ms Rebecca Streith
Lived Experience Consultant
Platform for Adaptive Trials in Perinatal Units