Premature Birth Clinical Trial
Official title:
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | August 2013 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Pregnant subjects, aged 18-45 years, pregnancy week 26 to 36+6, with history of previous preterm delivery or with premature contractions. Exclusion Criteria: - Subject with ruptured membranes. - Subject with signs and symptoms of pelvic inflammatory disease. - Subject who has used vaginal douching within 12 hours prior to arrival at the hospital. - Subject who has applied local antiseptic, antibiotic or vaginal treatment within the previous 3 days. - Subjects who have had sexual intercourse within the last 12 hours. - Subject with blood in her vaginal secretions. - Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study. - Subject is unable or unwilling to cooperate with study procedures. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | Department of Obstetrics and Gynecology | Nahariya |
Lead Sponsor | Collaborator |
---|---|
Western Galilee Hospital-Nahariya | Common Sense |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Does screening for BV using VS-SENSE in pregnant women with h/o preterm delivery or with premature contractions, and treatment will reduce or prevent Late miscarriage, preterm birth, preterm PROM, chorioamnionitis, and postpartum endometritis. | One year | No |
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