Trials / Unknown
UnknownNCT01152528
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
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.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 248 (estimated)
- Sponsor
- Common Sense · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.
Conditions
- Vaginal Infections
- Bacterial Vaginosis
- Late Miscarriage
- Preterm Birth
- Preterm Premature Rupture of Membranes
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2010-06-29
- Last updated
- 2010-06-29
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT01152528. Inclusion in this directory is not an endorsement.