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Vaginal Probiotics During Pregnancy After Premature Rupture of Membranes

NCT06878443 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-04

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota.

The main questions it aims to answer are:

* Is babies' microbiota differs with premature water breaking than full-term babies microbiota?
* Is vaginal probiotics given to the mother influence the baby microbiota? Researchers will compare vaginal probiotics use to no treatment to see if the babies microbiota and mother microbiota is influenced.

Participants will

* Take vaginal probiotics between premature breaking water until delivery (group A)
* Keep a diary of their symptoms and compliance to treatment (group A)
* Take samples of vaginal secretions and of baby's stool (all groups)

Conditions

  • Pregnancy
  • Prematurity
  • PPROM

Interventions

OTHER

Vaginal probiotics

Probiotics from Canadian company Lallemand Health Solutions are stored at room temperature and administered vaginally.

Sponsors & Collaborators

  • Lallemand Health Solutions

    collaborator INDUSTRY

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

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2025-06-17
Completion
2025-06-17

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 NCT06878443 on ClinicalTrials.gov