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NOT YET RECRUITING
NCT06906757
NA

Preterm Rupture of Membranes Optimising Antibiotics Trial

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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

Conditions

Interventions

DRUG

Erythromycin 250mg + placebo

Antibiotic.

DRUG

Azithromycin 500mg + placebo

Antibiotic.

DRUG

Erythromycin 250mg and Amoxicillin 500mg

Antibiotics.