Probiotic: Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
Placebo: Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Recruitment rate — 7 months To assess the feasibility of the study, each local site team will complete a dashboard documenting every individual met and informed about the study. This dashboard will be used to calculate the recruitment rate, using the formula:
Recruitment rate = (Number of eligible patients - Number of patients who did not consent) / Number of eligible patients Additionally, the dashboard will track reasons for acceptance or refusal.
Feasability dashboard — 7 months The attrition rate will be explored to assess feasability of the study. Attrititon rate = (# participants who dropped out / total of participants).
Treatment adherence — 7 months Finally, number of caps took during the treatment phase will be reported to explore the adherence of treatment.
Trial sites (1)
Facility
City
Region
Status
Centre de recherche du CHUM
Montreal
Quebec
More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.