A Study of HSV Testing Among Pregnant Women

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00194415
• Other study ID #: 03-9950-E/A
• Secondary ID: P01AI030731
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 29, 2007
• Start date: January 2004
• Est. completion date: November 2006

Study information

• Verified date: December 2007
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 173
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Exclusion Criteria:

• History of genital herpes

• HIV seropositive

• Any contraindication for sexual activity during pregnancy

Study Design

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

Related Conditions & MeSH terms

• Herpes Simplex
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Canada	Children's & Women's Health Centre of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No