NCT06965049

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

Multicentric Clinical Pilot Trial Testing the Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 24 and 32 Weeks of Amenorrhea ( PROB-PROM Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Premature rupture of fetal membranes before labor (PPROM) accounts for 30% of preterm births. Since PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during the latent period (LP) (the interval between rupture and birth). While they prolong the LP and improve neonatal health, they also exacerbate pre-existing vaginal dysbiosis. The addition of vaginal probiotics (VP) helps stabilize the vaginal microbiota (VM) and increase Lactobacillus levels. By enhancing the presence of beneficial bacteria in the vagina, probiotics help restore the balance between beneficial and pathogenic microbes, potentially reducing uterine infection and improving the fetal intestinal microbiota. Pathophysiological Hypotheses for Improving Neonatal Health The use of VP may influence neonatal outcomes through three potential mechanisms: i) Reduction of vaginal dysbiosis: Prolongs pregnancy and mitigates complications related to fetal immaturity (e.g., decreases risk of intraventricular hemorrhage). ii) Reduction of intrauterine infection/inflammation: Lowers neonatal complications associated with inflammation (e.g., reduces incidence of cystic periventricular leukomalacia). iii) Improvement of neonatal intestinal microbiota (NIM) through probiotic ingestion: Decreases complications linked to neonatal dysbiosis (e.g., reduces risk of necrotizing enterocolitis \[NEC\]). Primary Objectives * To assess the validity of: i) A recruitment rate \> 35% ii) A treatment adherence rate \> 80% iii) A sample attrition rate \< 5% * To identify barriers and facilitators in different settings for the implementation of the randomized controlled trial (RCT). Secondary Objectives * To compare the presence of probiotics in the vaginal microbiota and neonatal stool (meconium and at 7 days of life). * To measure the effect of probiotics on the evolution of maternal vaginal microbiota and neonatal intestinal microbiota. Population Pregnant women aged 18 years or older giving birth at one of the eight centers participating in the study in Quebec and Ontario, Canada. Participants will be randomly assigned, in a blinded manner, to either the probiotic or placebo group.

Conditions

• Pregnancy
• Prematurity
• PPROM

Interventions

Type	Name	Description
OTHER	Probiotic	Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
OTHER	Placebo	Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-05-11
• Last updated: 2025-05-11

Locations

1 site across 1 country: Canada