Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
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|ClinicalTrials.gov Identifier: NCT00491270|
Recruitment Status : Unknown
Verified May 2011 by Western Galilee Hospital-Nahariya.
Recruitment status was: Not yet recruiting
First Posted : June 26, 2007
Last Update Posted : May 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Vaginosis, Bacterial Abortion, Spontaneous Premature Birth||Device: VS Sense||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||August 2013|
- Device: VS Sense
An applicator to diagnose pH increase above 5.2
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491270
|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|