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NOT YET RECRUITING
NCT06965049
NA

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

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Centre de recherche du CHUM

Montreal, Quebec, Canada