Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery
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|ClinicalTrials.gov Identifier: NCT01152528|
Recruitment Status : Unknown
Verified June 2010 by Common Sense.
Recruitment status was: Not yet recruiting
First Posted : June 29, 2010
Last Update Posted : June 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Infections Bacterial Vaginosis Late Miscarriage Preterm Birth Preterm Premature Rupture of Membranes||Device: VA-SENSE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||VA-SENSE - BACTERIAL VAGINOSIS ONCE A WEEK SCREENING AND TREATMENT TO REDUCE INFECTIVE COMPLICATIONS, ABORTION AND PRETERM DELIVERY IN PREGNANT WOMEN WITH PREVIOUS PRETERM DELIVERY.|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2011|
- Device: VA-SENSE
The VA-SENSE contains a strip of pH indicator (color indicator) that is sensitive to the acidity level. A change in the color of the strip due to changes in the acidity level of vaginal secretions absorbed in the panty liner clearly indicates high probability of bacterial or parasitic vaginal infection. Any color change that results from contact with urine will disappear 10 minutes of drying out, and then the color of the indicator strip will fade back to the original color (yellow).
- Incidence of preterm birth, gestational week at delivery. [ Time Frame: 9 months ]Each participant will use at least 8 VA-SENSE (maximum 20 TPLs), once a week for at least 8 weeks (maximum 20 weeks), or will be screened by VS-SENSE once during pregnancy.
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): NCT01152528
|Contact: Hadar Kessary, PhD||972-4-6277101 ext 126||HADAR@CS-COMMONSENSE.COM|
|Contact: Jacob Bornstein, Proffesoremail@example.com|
|Western Galilee Hospital||Not yet recruiting|
|Nahariya, Western Galilee, Israel, 22100|
|Contact: hadar kessary, PhD 972-4-6277101 ext 1 HADAR@CS-COMMONSENSE.COM|
|Contact: Jacob Bonstein, Prof 972-4-9107517 firstname.lastname@example.org|
|Principal Investigator: Jacob Borenstein, Prof|