Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT06906757
Eligibility Criteria:
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:
1. 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
2. Are eligible for at least two treatment arms within the domain
3. The fetus/fetuses are alive at randomisation
4. 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:
1. Antibiotic treatment for \> 24 hours administered with the aim of preventing infection from PPROM
2. Suspected maternal or fetal infection (chorioamnionitis)
3. Maternal or fetal indication for immediate birth
4. Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)
5. No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection/s
6. Women with a previous infant affected by GBS sepsis
7. 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.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT06906757
Study Brief:
Protocol Section:
NCT06906757