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Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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
Official title: 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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-09-01
Completion Date
2026-05
Last Updated
2025-05-11
Healthy Volunteers
No
Conditions
Interventions
Probiotic
Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
Placebo
Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
Locations (1)
Centre de recherche du CHUM
Montreal, Quebec, Canada