Multicentric randomized controlled trial of feasibility testing the association between antibiotics and vaginal probiotics for patients with premature and preterm rupture of membranes between 24 and 32 weeks of amenorrhea
Premature and preterm rupture of membranes for pregnancy of 24-32 weeks of amennorhea
Randomization will be programmed in SAS by a statistician and performed online using the REDCap software system. Participants are assigned 1:1 to placebo or vaginal probiotics as a mix of probiotics strain. The participant takes one intravaginal capsule once a day at bedtime between inclusion in the study until delivery.
1. Person of female sex 2. ≥18 years of age 3. Mono-fetal pregnancy 4. Treated for PPROM between 24 and 32 weeks of gestation with expectant management in one of the study centers 5. With latency period between 12 hours and <7 days 6. Speaking and able to read French or English
1. Presence of active labor 2. Situation contraindicating expectant management (e.g., infection) 3. Significant malformation, chromosomal anomaly, or fetal death 4. Signs of fetal distress 5. Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose 6. Allergy to soy or lactose 7. Weakened immune system (e.g., AIDS, prolonged corticosteroid treatment, etc) 8. Vaginal probiotics intake 15 days before study inclusion 9. Oral probiotic intake 30 days before study inclusion