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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About 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

Qualifiers

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.

Disqualifiers

Presence of active labor;

Situation contraindicating expectant management (e.g., infection);

Significant malformation, chromosomal anomaly, or fetal death;

Signs of fetal distress;

Trial design

Treatments tested in this trial

  • Probiotic
  • Placebo

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Lallemand Health Solutions, Canada

Collaborator