A Study of HSV Testing Among Pregnant Women

Not Applicable

Terminated

• Conditions: Herpes Simplex; Pregnancy
• Interventions: Procedure: Type specific serologic HSV testing; Behavioral: Safer-sex counseling

• Registration Number: NCT00194415
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-29
• Last Update Posted: 2008-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 173

Inclusion Criteria

• 14 years of age or older
• Pregnant less than 28 weeks at time of enrollment
• No previous HSV serology within the past year
• able to comprehend english

Read More

Exclusion Criteria

• History of genital herpes
• HIV seropositive
• Any contraindication for sexual activity during pregnancy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Type specific serologic HSV testing	HSV-2 antepartum testing
2	Safer-sex counseling	Subjects will receive safer-sex counseling during pregnancy

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Children's & Women's Health Centre of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada