WithdrawnNot Applicable

Vaginal Probiotics During Pregnancy After Premature Rupture of Membranes

Stopped: Important delays limiting study starts

Canada0Started 2025-06-17

Plain-language summary

The goal of this clinical trial is to compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota. The main questions it aims to answer are: * Is babies' microbiota differs with premature water breaking than full-term babies microbiota? * Is vaginal probiotics given to the mother influence the baby microbiota? Researchers will compare vaginal probiotics use to no treatment to see if the babies microbiota and mother microbiota is influenced. Participants will * Take vaginal probiotics between premature breaking water until delivery (group A) * Keep a diary of their symptoms and compliance to treatment (group A) * Take samples of vaginal secretions and of baby's stool (all groups)

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Groups A and B: Women ≥ 18 years of age, mono-fetal pregnancy, hospitalized for PPROM between 32 0/7 d and 36 0/7 d weeks of ammenorhea with LP \< 7 days in one of the participating centers, with expectant management, who have consented to participate, agree to collect samples and speak French or English Group C: Women ≥ 18 years, mono-fetal pregnancy, expected delivery in one of the participating centers and speaking French or English Exclusion Criteria: * Groups A and B: * Presence of active labor, * Situations contraindicating expectant management (e.g. infection), * Significant malformation, chromosomal abnormality or fetal death, * Signs of fetal distress, * vaginal probiotics intake 15 days before study entry. For Group A only: * Allergies to soy and/or milk; * Weakened immune system (e.g. AIDS, prolonged treatment with corticosteroids), * Not to have been treated with the following antibiotics during pregnancy: nalidixic acid (Negram) and/or cefoxitin (Mefoxin) and/or sulfamethoxazole (Bactrim). Group C: * History of obstetric complications (prematurity \<37 weeks, diagnosed pre-eclampsia, gestational diabetes treated with insulin), * Known obstetrical or fetal complications of the current pregnancy, such as threat of preterm delivery (premature rupture of membranes or preterm labor), chorioamnionitis, placenta previa, active vaginal bleeding, cervical cerclage, fetal distress or malformation, corticosteroid therapy, * Risk factors…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Probiotics primers presence

Timeframe: at birth and 7th day of life

Trial details

NCT IDNCT06878443

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-17

View on ClinicalTrials.gov More Pregnancy trials