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

NCT06965049 | Not Yet Recruiting DMC

• 1 other identifier: MP-02-2025-12882
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy; Prematurity; PPROM

Keywords

pregnancy; prematurity; PPROM; vaginal probiotics; microbiota

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  To assess the feasibility of the study, each local site team will complete a dashboard documenting every individual met and informed about the study. This dashboard will be used to calculate the recruitment rate, using the formula: Recruitment rate = (Number of eligible patients - Number of patients who did not consent) / Number of eligible patients Additionally, the dashboard will track reasons for acceptance or refusal.

  7 months

• Feasability dashboard

  The attrition rate will be explored to assess feasability of the study. Attrititon rate = (# participants who dropped out / total of participants).

  7 months

• Treatment adherence

  Finally, number of caps took during the treatment phase will be reported to explore the adherence of treatment.

  7 months

Secondary Outcomes (1)

• Probiotics primers

  From enrollement to infant 7th day of life

Study Arms (2)

Probiotics group

ACTIVE COMPARATOR

Probiotics is a mix of probiotic strains.

Other: Probiotic

Placebo group

PLACEBO COMPARATOR

Capsule of sugar, same appearance than the probiotic.

Other: Placebo

Interventions

Probiotic OTHER

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

Probiotics group

Placebo OTHER

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

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.);

Sponsors & Collaborators

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

Study Sites (1)

Centre de recherche du CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Premature Birth; Preterm Premature Rupture of the Membranes

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Jean-Charles Pasquier

CONTACT

819-679-2212; jean-charles.pasquier@umontreal.ca

Sarah Bilodeau

CONTACT

514-890-8000; sarah.bilodeau.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research pharmacy will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 11, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The supporting information will be shared before the end of the study.

Locations

CA (1)