A Study of HSV Testing Among Pregnant Women

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)

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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