Vaginal Probiotics for Premature Rupture of Membranes During Pregnancy
(PROBPROM-Pilot Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group

Trial Summary

What is the purpose of this trial?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 breaking water 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)

Eligibility Criteria

This trial is for pregnant women who've experienced premature rupture of membranes, leading to the risk of preterm birth. Participants will use vaginal probiotics from the time their waters break until delivery and keep a diary of symptoms.

Inclusion Criteria

I am a woman over 18, pregnant with one baby, had early water break between 32-36 weeks, and agree to sample collection.

I am a woman over 18, pregnant with one baby, planning to deliver at a participating center, and I speak French or English.

Exclusion Criteria

Signs of fetal distress (Groups A and B)

Presence of active labor (Groups A and B)

Vaginal probiotics intake 15 days before study entry (Groups A and B)

+12 more

Participant Groups

The study tests if vaginal probiotics can influence the microbiota (community of microbes) in both mothers and their babies born after premature water breaking, compared to those without treatment.

3Treatment groups

Experimental Treatment

Active Control

Group I: Probiotics groupExperimental Treatment1 Intervention

Pregnant women admitted to one of the center participating in the essay for PPROM accepting vaginal probiotics intake and sample collection

Group II: Control group - PPROMActive Control1 Intervention

Pregnant women admitted to one of the study's centers for PPROM without vaginal probiotics intake

Group III: Control group- Full TermActive Control1 Intervention

Pregnant women with expected full-term deliveries, without vaginal probiotics intake