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Clinical Trial Summary

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.


Clinical Trial Description

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:

- Group 1: Antepartum and postpartum testing. Subjects will be made aware of their antepartum testing results.

- Group 2: Antepartum blood draw and postpartum testing. Subjects' specimens will be tested at the same time.

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00194415
Study type Interventional
Source University of Washington
Contact
Status Terminated
Phase N/A
Start date January 2004
Completion date November 2006

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