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| ID | Type | Description | Link |
|---|---|---|---|
| P01AI030731 | U.S. NIH Grant/Contract | View source |
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An interim data analysis found no significant difference between testing groups.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The objective of the study is to evaluate the acceptance and effect of type- specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.
The study hypothesis is that women with antepartum testing who are identified as susceptible to HSV-1 or HSV-2 will have reduced unprotected coital activity and reduced unprotected oral-genital activity compared to those who did not receive antepartum testing. The objective of the study is to evaluate the acceptance, and effect of type-specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.
Upon enrollment, study participants will be randomized into either of two type-specific HSV serologic testing and counseling regimens:
Women in group 2 will receive information about herpes infection and how to decrease their chance of acquiring infection during pregnancy. Subjects will be asked to keep a diary of sexual activity and return to the clinic every 4 weeks until delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | HSV-2 antepartum testing |
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| 2 | Other | Subjects will receive safer-sex counseling during pregnancy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safer-sex counseling | Behavioral | Subjects will receive safer-sex counseling during pregnancy |
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| Measure | Description | Time Frame |
|---|---|---|
| The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2. | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| To determine HSV seroconversion rates in Group 1 versus Group 2 | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery | |
| To determine rates of neonatal HSV infection in Groups 1 & 2. | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Money, MD | University of British Columbia | Principal Investigator |
| Anna Wald, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's & Women's Health Centre of British Columbia | Vancouver | British Columbia | V6H 3N1 | Canada |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Type specific serologic HSV testing |
| Procedure |
Subjects will be testing for HSV by Western Blot |
|
| To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs. | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |
| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |