Pregnancy Clinical Trial
Official title:
A Randomized Clinical Trial of Antenatal vs Delayed (Post Partum) Testing for HSV Type-Specific Antibodies Among Pregnant Women.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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