Status:
WITHDRAWN
Vaginal Probiotics During Pregnancy After Premature Rupture of Membranes
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Lallemand Health Solutions
Conditions:
Pregnancy
Prematurity
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ba...
Detailed Description
Premature rupture of fetal membranes before labor (PPROM) reprensents 30% of premature births. As PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06878443
Start Date
June 17 2025
End Date
June 17 2025
Last Update
July 4 2025
Active Locations (1)
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1
CHUM Clinical research Centre
Montreal, Quebec, Canada, H2X 0A9