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Preterm Rupture of Membranes Optimising Antibiotics Trial

NCT06906757 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3900

Last updated 2025-04-02

No results posted yet for this study

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).

Conditions

  • PPROM
  • Preterm

Interventions

DRUG

Erythromycin 250mg + placebo

Antibiotic.

DRUG

Azithromycin 500mg + placebo

Antibiotic.

DRUG

Erythromycin 250mg and Amoxicillin 500mg

Antibiotics.

Sponsors & Collaborators

Principal Investigators

  • Clare Whitehead, MBChB, PhD · University of Melbourne and Royal Women's Hospital (Melbourne)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2029-12-31
Completion
2050-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906757 on ClinicalTrials.gov