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.
Device: VS Sense
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
|Official Title:||Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery|
- 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. [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Device: VS Sense
This is an open-label, comparative, and prospective study. Pregnant women, pregnancy week 26 to 36+6, between the ages 18-45, who were hospitalized in the high risk department, with history of previous preterm delivery and/or with premature contractions. Patient with premature ruptured membrane will be excluded.
In the hospital pregnant women with history of previous preterm delivery or with premature contractions, (participants) will be examined by speculum with no lubricant, The clinician will use the VS-SENSE to sample vaginal secretions and will immediately observe and record the color obtained.Should the VS-SENSE produce positive results the physician will consider giving clindamycin treatment.
|Contact: Jacob Bornstein, MD||+972-4-9107720|
|Department of Obstetrics and Gynecology||Not yet recruiting|
|Contact: Jacob Bornstein, MD|
|Principal Investigator:||Jacob Bornstein, MD||Western Galilee Hospital-Nahariya|