Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
173 participants
INTERVENTIONAL
2004-01-31
2006-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
HSV-2 antepartum testing
Type specific serologic HSV testing
Subjects will be testing for HSV by Western Blot
2
Subjects will receive safer-sex counseling during pregnancy
Safer-sex counseling
Subjects will receive safer-sex counseling during pregnancy
Interventions
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Safer-sex counseling
Subjects will receive safer-sex counseling during pregnancy
Type specific serologic HSV testing
Subjects will be testing for HSV by Western Blot
Eligibility Criteria
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Inclusion Criteria
* Pregnant less than 28 weeks at time of enrollment
* No previous HSV serology within the past year
* able to comprehend english
Exclusion Criteria
* HIV seropositive
* Any contraindication for sexual activity during pregnancy
14 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
University of Washington
OTHER
Responsible Party
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University of Washington
Principal Investigators
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Deborah Money, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Anna Wald, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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03-9950-E/A
Identifier Type: -
Identifier Source: org_study_id
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