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Preterm Rupture of Membranes Optimising Antibiotics Trial
Sponsor: University of Melbourne
Summary
The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics. PROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM \< 37+0 weeks' gestation. Researchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM. Participants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally. Neonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum. Questionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased. This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).
Official title: Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
3900
Start Date
2025-09
Completion Date
2050-12
Last Updated
2025-04-02
Healthy Volunteers
No
Interventions
Erythromycin 250mg + placebo
Antibiotic.
Azithromycin 500mg + placebo
Antibiotic.
Erythromycin 250mg and Amoxicillin 500mg
Antibiotics.