Clinical trial NCT00194415: 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
Overall status: TERMINATED
Phase: NA
Conditions: Herpes Simplex
Pregnancy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-19
Enrollment: 173
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.
timeFrame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
Secondary outcomes:
measure: To determine HSV seroconversion rates in Group 1 versus Group 2
timeFrame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
measure: To determine rates of neonatal HSV infection in Groups 1 & 2.
timeFrame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
measure: To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs.
timeFrame: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's & Women's Health Centre of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Deborah Money, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Anna Wald, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: