About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
Inability to consent for themselves
Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).
Maternal history consistent with loss of fluid per vagina
Evidence of a pool of fluid in the vagina on sterile speculum examination
Trial design
Treatments tested in this trial
- Erythromycin 250mg + placebo
- Azithromycin 500mg + placebo
- Erythromycin 250mg and Amoxicillin 500mg