ClinicalTrials.Veeva

Menu

A Study of HSV Testing Among Pregnant Women

University of Washington logo

University of Washington

Status

Terminated

Conditions

Herpes Simplex
Pregnancy

Treatments

Behavioral: Safer-sex counseling
Procedure: Type specific serologic HSV testing

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00194415
P01AI030731 (U.S. NIH Grant/Contract)
03-9950-E/A

Details and patient eligibility

About

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.

Full 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.

Enrollment

173 patients

Sex

Female

Ages

14+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

173 participants in 2 patient groups

1
Other group
Description:
HSV-2 antepartum testing
Treatment:
Procedure: Type specific serologic HSV testing
2
Other group
Description:
Subjects will receive safer-sex counseling during pregnancy
Treatment:
Behavioral: Safer-sex counseling

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems