NCT00194415

A Study of HSV Testing Among Pregnant Women

A Randomized Clinical Trial of Antenatal vs Delayed (Post Partum) Testing for HSV Type-Specific Antibodies Among Pregnant Women.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Herpes Simplex
• Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	Safer-sex counseling	Subjects will receive safer-sex counseling during pregnancy
PROCEDURE	Type specific serologic HSV testing	Subjects will be testing for HSV by Western Blot

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-09-19
• Last updated: 2008-01-10

Locations

1 site across 1 country: Canada