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

NCT06965049 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-11

No results posted yet for this study

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

Conditions

  • Pregnancy
  • Prematurity
  • PPROM

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

Sponsors & Collaborators

  • Lallemand Health Solutions, Canada

    collaborator UNKNOWN

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-03-01
Completion
2026-05-31

Countries

  • Canada

Study Locations

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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 NCT06965049 on ClinicalTrials.gov