Vaginal Probiotics During Pregnancy After Premature Breaking Waters

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the gut bacteria of babies born prematurely—after the water has broken early—compares to those of full-term babies. The research aims to find out if giving vaginal probiotics (which are good bacteria) to mothers affects their babies’ gut bacteria. To do this, some mothers will take these probiotics from the time their water breaks until they give birth, while others will not receive any treatment. Researchers will collect samples of the mothers' vaginal secretions and the babies' stool to analyze the differences.

To participate in this study, women must be at least 18 years old and have a single baby pregnancy that is managed in a hospital due to early water breaking, between 32 and 36 weeks of pregnancy. They should be able to speak either French or English and agree to help collect samples and keep a diary of their symptoms. However, certain conditions, such as active labor or severe infections, may prevent someone from joining the study. This trial is not yet recruiting participants, so more information will be available once it begins.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * 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
• Exclusion Criteria:
• * 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),
• • Antibiotics taken 15 days prior to inclusion,
• • Taking probiotics 15 days prior to inclusion,
• • Tested positive for Streptococcus group B during previous pregnancies (as this will require antibiotics at delivery),
• • Presence of symptoms such as fever, nausea, vomiting, bloody diarrhea or severe abdominal pain.