A Randomized Clinical Trial of Antenatal vs Delayed (Post Partum) Testing for HSV Type-Specific Antibodies Among Pregnant Women.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •History of genital herpes
- •HIV seropositive
- •Any contraindication for sexual activity during pregnancy
结局指标
主要结局
The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.
时间窗: From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
次要结局
- 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)