Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery

• Status: Withdrawn
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal flora and cytokine profile during pregnancy, and the incidence of preterm labour in women at high risk for preterm birth.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Collaborator: Canadian Institutes of Health Research (CIHR)

Criteria

Inclusion Criteria:

• pregnant women with previous incidence of preterm labour

• otherwise healthy

• over 18 years of age

• able to provide informed consent

• less than or equal to 16 weeks gestation

• singleton pregnancy

• normal uterine cavity

Exclusion Criteria:

• significant medical complications (preeclampsia, thrombophilia, hypertension)

• multiple pregnancy

• less than 18 years of age

• patients receiving antibiotics or other antimicrobial therapies at time of recruitment

• fetal complications such as intrauterine growth restriction or other abnormalities

• diabetes

• documented need for cervical cerclage

• patient enrolled in other clinical trials