A Study of HSV Testing Among Pregnant Women

December 29, 2007 updated by: University of Washington

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Children's & Women's Health Centre of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
HSV-2 antepartum testing
Procedure: Type specific serologic HSV testing
Subjects will be testing for HSV by Western Blot
Other: 2
Subjects will receive safer-sex counseling during pregnancy
Behavioral: Safer-sex counseling
Subjects will receive safer-sex counseling during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine HSV seroconversion rates in Group 1 versus Group 2
Time Frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
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.
Time Frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
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.
Time Frame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Deborah Money, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 10, 2008

Last Update Submitted That Met QC Criteria

December 29, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-9950-E/A
  • P01AI030731 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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