Status:
NOT_YET_RECRUITING
Preterm Rupture of Membranes Optimising Antibiotics Trial
Lead Sponsor:
University of Melbourne
Conditions:
PPROM
Preterm
Eligibility:
FEMALE
Phase:
NA
Brief 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...
Detailed Description
PROMOAT aims to determine which of the most common antibiotic regimens are most effective in preventing infection in pregnant people with PPROM to improve health outcomes for their infants. PROMOAT is...
Eligibility Criteria
Inclusion
- 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:
- 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
- Are eligible for at least two treatment arms within the domain
- The fetus/fetuses are alive at randomisation
- 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:
- Antibiotic treatment for \> 24 hours administered with the aim of preventing infection from PPROM
- Suspected maternal or fetal infection (chorioamnionitis)
- Maternal or fetal indication for immediate birth
- Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)
- No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection/s
- Women with a previous infant affected by GBS sepsis
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2050
Estimated Enrollment :
3900 Patients enrolled
Trial Details
Trial ID
NCT06906757
Start Date
September 1 2025
End Date
December 1 2050
Last Update
April 2 2025
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