Vaginal Probiotics for Premature Rupture of Membranes During Pregnancy
(PROBPROM-Pilot Trial)
What You Need to Know Before You Apply
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 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)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain antibiotics or probiotics 15 days before joining. If you are in Group A, you should not have been treated with specific antibiotics during pregnancy.
Are vaginal probiotics safe for use during pregnancy?
How do vaginal probiotics differ from other treatments for premature rupture of membranes during pregnancy?
Vaginal probiotics are unique because they aim to restore the natural balance of bacteria in the vagina, which can help prolong the time before delivery and improve outcomes for the baby. Unlike standard treatments that primarily use antibiotics to prevent infection, probiotics focus on enhancing the body's natural defenses by promoting healthy bacteria growth.13456
What data supports the effectiveness of the treatment Vaginal Probiotics for Premature Rupture of Membranes During Pregnancy?
Research suggests that using vaginal probiotics, specifically Lactobacillus rhamnosus and L. gasseri, can help extend the time before delivery in cases of premature rupture of membranes, allowing more time for the baby's lungs to mature. Although some studies did not find significant differences in the time to delivery, they noted better overall outcomes for newborns when probiotics were used.13457
Are You a Good Fit for This Trial?
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.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take vaginal probiotics from premature rupture of membranes until delivery and keep a diary of symptoms and compliance
Follow-up
Participants are monitored for safety and effectiveness after treatment, including sample collection from mothers and babies
Extension
Long-term monitoring of mother and baby health issues and probiotics presence in samples
What Are the Treatments Tested in This Trial?
Interventions
- Vaginal Probiotics
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Lallemand Health Solutions
Industry Sponsor