Status:
WITHDRAWN
Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Premature Birth
Bacterial Vaginosis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief 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 pret...
Detailed Description
Preterm labour involves multiple causes - one of the most significant factors being a prior history of preterm birth. Infection is another major cause of preterm labour (PTL) and is estimated to cause...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00217308
Start Date
February 1 2005
End Date
September 1 2007
Last Update
August 31 2017
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5