Status:
NOT_YET_RECRUITING
Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Lallemand Health Solutions, Canada
Conditions:
Pregnancy
Prematurity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 r...
Detailed Description
Premature rupture of fetal membranes before labor (PPROM) accounts for 30% of preterm births. Since PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06965049
Start Date
September 1 2025
End Date
May 1 2026
Last Update
May 11 2025
Active Locations (1)
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1
Centre de recherche du CHUM
Montreal, Quebec, Canada, H2X 0A9