Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-05-31

Brief Summary

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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

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Detailed Description

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Premature rupture of fetal membranes before labor (PPROM) accounts for 30% of preterm births. Since PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during the latent period (LP) (the interval between rupture and birth). While they prolong the LP and improve neonatal health, they also exacerbate pre-existing vaginal dysbiosis. The addition of vaginal probiotics (VP) helps stabilize the vaginal microbiota (VM) and increase Lactobacillus levels. By enhancing the presence of beneficial bacteria in the vagina, probiotics help restore the balance between beneficial and pathogenic microbes, potentially reducing uterine infection and improving the fetal intestinal microbiota.

Pathophysiological Hypotheses for Improving Neonatal Health

The use of VP may influence neonatal outcomes through three potential mechanisms:

i) Reduction of vaginal dysbiosis: Prolongs pregnancy and mitigates complications related to fetal immaturity (e.g., decreases risk of intraventricular hemorrhage).

ii) Reduction of intrauterine infection/inflammation: Lowers neonatal complications associated with inflammation (e.g., reduces incidence of cystic periventricular leukomalacia).

iii) Improvement of neonatal intestinal microbiota (NIM) through probiotic ingestion: Decreases complications linked to neonatal dysbiosis (e.g., reduces risk of necrotizing enterocolitis \[NEC\]).

Primary Objectives

* To assess the validity of:

i) A recruitment rate \> 35% ii) A treatment adherence rate \> 80% iii) A sample attrition rate \< 5%
* To identify barriers and facilitators in different settings for the implementation of the randomized controlled trial (RCT).

Secondary Objectives

* To compare the presence of probiotics in the vaginal microbiota and neonatal stool (meconium and at 7 days of life).
* To measure the effect of probiotics on the evolution of maternal vaginal microbiota and neonatal intestinal microbiota.

Population Pregnant women aged 18 years or older giving birth at one of the eight centers participating in the study in Quebec and Ontario, Canada. Participants will be randomly assigned, in a blinded manner, to either the probiotic or placebo group.

Conditions

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Pregnancy Prematurity PPROM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Research pharmacy will be blinded

Study Groups

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Probiotics group

Probiotics is a mix of probiotic strains.

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type OTHER

Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery

Placebo group

Capsule of sugar, same appearance than the probiotic.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery

Interventions

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Probiotic

Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery

Intervention Type OTHER

Placebo

Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women ≥ 18 years of age;
* mono-fetal pregnancy;
* treated for PPROM between 24 and 32 weeks of gestation with latency period between 12 hours and \< 7 days in one of the study centers with expectant management;
* speaking and able to read French or English.

Exclusion Criteria

* Presence of active labor;
* Situation contraindicating expectant management (e.g., infection);
* Significant malformation, chromosomal anomaly, or fetal death;
* Signs of fetal distress;
* Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose;
* Allergy to soy or lactose;
* Weakened immune system (e.g., AIDS, prolonged corticosteroid treatment, etc.);
* Vaginal probiotics intake 15 days before study inclusion;
* Oral probiotic intake 30 days before study inclusion.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No