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A Study of HSV Testing Among Pregnant Women

Primary Purpose

Herpes Simplex, Pregnancy

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Safer-sex counseling

Type specific serologic HSV testing

About this trial

This is an interventional prevention trial for Herpes Simplex

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Children's & Women's Health Centre of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

HSV-2 antepartum testing

Subjects will receive safer-sex counseling during pregnancy

Outcomes

Primary Outcome Measures

The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.

Secondary Outcome Measures

To determine HSV seroconversion rates in Group 1 versus Group 2

To determine rates of neonatal HSV infection in Groups 1 & 2.

To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs.

Full Information

NCT ID

NCT00194415

First Posted

September 12, 2005

Last Updated

December 29, 2007

Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT00194415

Brief Title

A Study of HSV Testing Among Pregnant Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Terminated

Why Stopped

An interim data analysis found no significant difference between testing groups.

Study Start Date

January 2004 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Simplex, Pregnancy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

173 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

HSV-2 antepartum testing

Arm Title

Arm Type

Other

Arm Description

Subjects will receive safer-sex counseling during pregnancy

Intervention Type

Behavioral

Intervention Name(s)

Safer-sex counseling

Intervention Description

Subjects will receive safer-sex counseling during pregnancy

Intervention Type

Procedure

Intervention Name(s)

Type specific serologic HSV testing

Intervention Description

Subjects will be testing for HSV by Western Blot

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah Money, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anna Wald, MD, MPH

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's & Women's Health Centre of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3N1

Country

Canada

12. IPD Sharing Statement

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A Study of HSV Testing Among Pregnant Women

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