60 Participants Needed

Vaginal Probiotics for Premature Rupture of Membranes During Pregnancy

(PROBPROM-Pilot Trial)

JP
SB
Overseen BySarah Bilodeau
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must be taking: Vaginal probiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Studies show that using vaginal probiotics during pregnancy, such as Lactobacillus strains, generally does not cause any harm and may even improve outcomes for some conditions. However, more large-scale research is needed to confirm these findings.12345

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

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)
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take vaginal probiotics from premature rupture of membranes until delivery and keep a diary of symptoms and compliance

Variable, until delivery
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sample collection from mothers and babies

30 days after delivery
Sample collection at birth and 7 days after birth

Extension

Long-term monitoring of mother and baby health issues and probiotics presence in samples

Up to 13 months

What Are the Treatments Tested in This Trial?

Interventions

  • Vaginal Probiotics
Trial Overview 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Lallemand Health Solutions

Industry Sponsor

Trials
44
Recruited
4,100+
Founded
1934
Headquarters
Mirabel, Canada
Known For
Microbiome therapies
Top Products
Lacidofil, ProbioKid, Probio'Stick, IBacilluS+

Citations

Vaginal Probiotic Administration in the Management of Preterm Premature Rupture of Membranes. [2018]
Vaginal probiotics on the outcomes of premature rupture of membranes: a pilot randomised clinical trial. [2023]
Vaginal probiotics as an adjunct to antibiotic prophylaxis in the management of preterm premature rupture of membranes: A systematic review and meta-analysis of randomized controlled trials. [2023]
Vaginal probiotics as an adjunct to antibiotic prophylaxis in the management of preterm premature rupture of the membranes. [2022]
Characterization of Vaginal Microbiota in Third Trimester Premature Rupture of Membranes Patients through 16S rDNA Sequencing. [2023]
Effect of Oral Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 on the Vaginal Microbiota, Cytokines and Chemokines in Pregnant Women. [2022]
[Bacteriologic studies in premature rupture of fetal membranes and correlation with the clinical aspects of chorioamnionitis and the amnion infection syndrome]. [2008]
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