Premature Birth Clinical Trial
Official title:
Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery
Verified date | August 2017 |
Source | Mount Sinai Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mount Sinai Hospital, Canada | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination if restoration of a normal vaginal flora through the use of probiotics reduces the incidence of PTB. | 12 weeks |
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