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Trial record 62 of 126 for:    HSV-2

A Study of HSV Testing Among Pregnant Women

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ClinicalTrials.gov Identifier: NCT00194415
Recruitment Status : Terminated (An interim data analysis found no significant difference between testing groups.)
First Posted : September 19, 2005
Last Update Posted : January 10, 2008
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Pregnancy Behavioral: Safer-sex counseling Procedure: Type specific serologic HSV testing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Antenatal vs Delayed (Post Partum) Testing for HSV Type-Specific Antibodies Among Pregnant Women.
Study Start Date : January 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Arm Intervention/treatment
1
HSV-2 antepartum testing
Procedure: Type specific serologic HSV testing
Subjects will be testing for HSV by Western Blot

2
Subjects will receive safer-sex counseling during pregnancy
Behavioral: Safer-sex counseling
Subjects will receive safer-sex counseling during pregnancy




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194415


Locations
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Canada, British Columbia
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Deborah Money, MD University of British Columbia
Principal Investigator: Anna Wald, MD, MPH University of Washington

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Responsible Party: Anna Wald, MD, MPH / Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00194415     History of Changes
Other Study ID Numbers: 03-9950-E/A
P01AI030731 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: December 2007
Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases