Herpes Simplex, Pregnancy
Conditions
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.
Interventions
BEHAVIORALSafer-sex counseling
Subjects will receive safer-sex counseling during pregnancy
PROCEDUREType specific serologic HSV testing
Subjects will be testing for HSV by Western Blot
Sponsors
National Institutes of Health (NIH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2. | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |
Secondary
| Measure | Time frame |
|---|---|
| To determine HSV seroconversion rates in Group 1 versus Group 2 | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |
| To determine rates of neonatal HSV infection in Groups 1 & 2. | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |
| To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs. | From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery |
Countries
Canada
Outcome results
None listed