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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VA-SENSE | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of preterm birth, gestational week at delivery. | 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. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadar Kessary, PhD | Contact | 972-4-6277101 | 126 | HADAR@CS-COMMONSENSE.COM |
| Jacob Bornstein, Proffesor | Contact | 972-4-9107517 | mdjacob@techunix.technion.ac.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Galilee Hospital | Nahariya | Western Galilee | 22100 | Israel |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D016585 | Vaginosis, Bacterial |
| D047928 | Premature Birth |
| C563032 | Preterm Premature Rupture of the Membranes |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
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