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| Name | Class |
|---|---|
| Common Sense | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VS Sense | Device | An applicator to diagnose pH increase above 5.2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob Bornstein, MD | Contact | +972-4-9107720 |
| Name | Affiliation | Role |
|---|---|---|
| Jacob Bornstein, MD | Western Galilee Hospital-Nahariya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology | Nahariya | Israel |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D000022 | Abortion, Spontaneous |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011248 | Pregnancy Complications |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |