Vaginal Probiotics During Pregnancy After Premature Rupture of Membranes

NCT06878443 | Withdrawn DMC

• 1 other identifier: MP-02-2025-12298
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Pregnancy; Prematurity; PPROM

Keywords

pregnancy; prematurity; PPROM; vaginal probiotics; microbiota

Outcome Measures

Primary Outcomes (1)

• Probiotics primers presence

  Evaluate the presence or absence of probiotics in the meconium and stools of 7-day-old babies using specific primers to detect strains

  at birth and 7th day of life

Secondary Outcomes (5)

• Recruitment rate

  12 months

• Numbers of mother and baby health issues

  During the enrollment until 30 days after delivery

• Probiotics primers in other samples presence

  between the enrollment until 30 days after delivery

• Attrition rate

  13 months

• Treatment adherence

  13 months

Study Arms (3)

Probiotics group

EXPERIMENTAL

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

Other: Vaginal probiotics

Control group - PPROM

NO INTERVENTION

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

Control group- Full Term

NO INTERVENTION

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

Interventions

Vaginal probiotics OTHER

Probiotics from Canadian company Lallemand Health Solutions are stored at room temperature and administered vaginally.

Probiotics group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Groups A and B:
• Women ≥ 18 years of age, mono-fetal pregnancy, hospitalized for PPROM between 32 0/7 d and 36 0/7 d weeks of ammenorhea with LP \< 7 days in one of the participating centers, with expectant management, who have consented to participate, agree to collect samples and speak French or English
• Group C:
• Women ≥ 18 years, mono-fetal pregnancy, expected delivery in one of the participating centers and speaking French or English

You may not qualify if:

• Groups A and B:
• Presence of active labor,
• Situations contraindicating expectant management (e.g. infection),
• Significant malformation, chromosomal abnormality or fetal death,
• Signs of fetal distress,
• vaginal probiotics intake 15 days before study entry.
• For Group A only:
• Allergies to soy and/or milk;
• Weakened immune system (e.g. AIDS, prolonged treatment with corticosteroids),
• Not to have been treated with the following antibiotics during pregnancy: nalidixic acid (Negram) and/or cefoxitin (Mefoxin) and/or sulfamethoxazole (Bactrim).
• Group C:
• History of obstetric complications (prematurity \<37 weeks, diagnosed pre-eclampsia, gestational diabetes treated with insulin),
• Known obstetrical or fetal complications of the current pregnancy, such as threat of preterm delivery (premature rupture of membranes or preterm labor), chorioamnionitis, placenta previa, active vaginal bleeding, cervical cerclage, fetal distress or malformation, corticosteroid therapy,
• Risk factors for obstetrical complications during pregnancy, such as gestational diabetes, type I/II diabetes and high blood pressure (systole ≥ 140 and diastole ≥ 90),
• Tested positive for Streptococcus group B during previous pregnancies (as this will require antibiotics at delivery),

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

CHUM Clinical research Centre

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Premature Birth; Preterm Premature Rupture of the Membranes

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Vaginal Probiotics 1x/day until delivery

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: March 17, 2025
• Study Start: June 17, 2025
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

CA (1)