Vaginal Probiotics for Premature Rupture of Membranes

(PROB-PROM Trial)

Overseen By Sarah Bilodeau

Age: 18+

Sex: Female

Trial Phase: Academic

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

Must not be taking: Vaginal probiotics, Oral probiotics

Disqualifiers: Active labor, Infection, Fetal distress, Weakened immune system, others

Compensation: Varies

Number of Visits: Unknown

Duration: From membrane rupture until delivery

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT). Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups. To achieve this, participants will be asked to: * Use the vaginal study product from the time of membrane rupture until delivery * Keep a diary documenting their symptoms and treatment adherence * Provide vaginal secretion samples and stool samples from their baby

Eligibility Criteria

This trial is for pregnant individuals who experienced early water breaking (premature rupture of membranes) between 24-32 weeks of gestation. Participants will use a vaginal product and keep a diary on symptoms and adherence, as well as provide samples from themselves and their baby.

Inclusion Criteria

Mono-fetal pregnancy

I was treated for early water break between 24-32 weeks of pregnancy and was monitored without immediate delivery.

I can speak and read either French or English.

Exclusion Criteria

My unborn baby is showing signs of distress.

Allergy to soy or lactose

Vaginal probiotics intake 15 days before study inclusion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the vaginal study product from the time of membrane rupture until delivery and keep a diary documenting their symptoms and treatment adherence

From membrane rupture until delivery

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the collection of vaginal secretion samples and stool samples from their baby

From enrollment to infant 7th day of life

Treatment Details

Interventions

• Vaginal Probiotics

Trial Overview The study tests the effects of vaginal probiotics versus placebo in managing pregnancies with premature rupture of membranes. It aims to see if this approach is feasible and how it affects the microbiota of preterm babies.

Participant Groups

Group I: Probiotics group Active Control 1 Intervention

Probiotics is a mix of probiotic strains.

Group II: Placebo group Placebo Group 1 Intervention

Capsule of sugar, same appearance than the probiotic.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Lallemand Health Solutions, Canada

Collaborator

Trials

1

Recruited

80+