About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Presence of active labor;
Situation contraindicating expectant management (e.g., infection);
Significant malformation, chromosomal anomaly, or fetal death;
Signs of fetal distress;
Trial design
Treatments tested in this trial
- Probiotic
- Placebo
Treatment groups
Sponsors and collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Lallemand Health Solutions, Canada
Collaborator