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
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.
Presence of active labor;
Situation contraindicating expectant management (e.g., infection);
Significant malformation, chromosomal anomaly, or fetal death;
Signs of fetal distress;
Parallel
Probiotic
Other interventionParticipant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
Placebo
Other interventionParticipant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
Recruitment rate
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
The attrition rate will be explored to assess feasability of the study. Attrititon rate = (# participants who dropped out / total of participants).
Treatment adherence
Finally, number of caps took during the treatment phase will be reported to explore the adherence of treatment.
Probiotics primers
Evaluate the presence or absence of probiotics in the various samples, i.e. vaginal secretions, meconium and 7-day-old baby's stool, using specific primers to detect strains.
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Lallemand Health Solutions, Canada
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
