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

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · May 1, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of vaginal probiotics for women who experience premature rupture of membranes during pregnancy, which means their water breaks early, between 24 and 32 weeks. The main goal is to see if using these probiotics is a feasible option for improving health outcomes for both mothers and their preterm babies. Researchers also want to compare the gut bacteria in babies born preterm to understand how the probiotics might affect them.

To participate, women must be at least 18 years old, pregnant with a single baby, and have been treated for premature rupture of membranes within a specific time frame. They should be able to read and speak either French or English. Participants will use the probiotics from the time their water breaks until they deliver and will need to keep a diary of their symptoms and how well they're following the treatment. Additionally, they will provide samples of vaginal secretions and their baby’s stool for further analysis. It's important to note that women with certain conditions, such as signs of active labor or infections, won't be eligible for this trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • women ≥ 18 years of age;
• • mono-fetal pregnancy;
• • treated for PPROM between 24 and 32 weeks of gestation with latency period between 12 hours and \< 7 days in one of the study centers with expectant management;
• • speaking and able to read French or English.
• Exclusion Criteria:
• • Presence of active labor;
• • Situation contraindicating expectant management (e.g., infection);
• • Significant malformation, chromosomal anomaly, or fetal death;
• • Signs of fetal distress;
• • Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose;
• • Allergy to soy or lactose;
• • Weakened immune system (e.g., AIDS, prolonged corticosteroid treatment, etc.);
• • Vaginal probiotics intake 15 days before study inclusion;
• • Oral probiotic intake 30 days before study inclusion.