Clinical Trial

Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes

Study acronym: PROB-PROM
Not Yet Recruiting
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Record status
This record was last updated May 11, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT). Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups. To achieve this, participants will be asked to: * Use the vaginal study product from the time of membrane rupture until delivery * Keep a diary documenting their symptoms and treatment adherence * Provide vaginal secretion samples and stool samples from their baby
Trial Details
NCT Number NCT06965049
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Lallemand Health Solutions, Canada
Conditions Pregnancy, Prematurity, PPROM
Enrollment 80 participants
Start Date 2025-09-01
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-05-11