Vaginal Probiotics During Pregnancy After Premature Breaking Waters

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

Keywords

ClinConnect Summary

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 latent period (LP) (the interval between rupture and birth). They prolong the LP and improve the health of the children, but they also aggravate pre-existing vaginal dysbiosis. The addition of vaginal probiotics (VP) stabilizes the vaginal microbiota (VM) and increases Lactobacillus levels. By increasing the number of good germs in the vagina, they will rebalance the good germs and the pathogen...

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.