跳至主要内容
临床试验/NCT00291044
NCT00291044已完成不适用

HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

Stony Brook University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
% of patients willing to be tested

研究概览

简要总结

Brief summary: The current management guidelines recommended by ACOG rely on history as a screening method to determine pregnant women who are at risk for transmitting herpes to their newborn. History fails completely in identifying the women most at risk of transmitting herpes to their newborn - the seronegative woman who acquires a primary infection from her partner during pregnancy. Despite recent advances, both pregnant women and newborns continue to be at risk of acquiring herpes infection. Genital herpes infections are epidemic in the United States. In the early 1990's, 25% of women in the US were seropositive for the HSV-2 antibody. These numbers are likely higher now. The incidence of neonatal herpes in the US cannot be accurately estimated since it is not a reportable disease. However, in some areas of the US, the incidence is 1 in 3,200 live births which would translate to an incidence of approximately three infants a day in the US . In other areas of the US, the incidence is even higher, approaching 1 in 1,500 liveborns. This protocol examines patient acceptance of HSV-1 and HSV-2 type specific serologic testing and assesses patient counseling tools. In addition, seroprevalence of HSV-2 in pregnant patients will be collected and evaluated.

详细描述

Detailed Description: Despite recent advances, both pregnant women and newborns continue to be at risk of acquiring herpes infection. Genital herpes infections are epidemic in the United States. In the early 1990's, 25% of women in the US were seropositive for the HSV-2 antibody (Fleming, 1997). These numbers are likely higher now. The incidence of neonatal herpes in the US cannot be accurately estimated since it is not a reportable disease. However, in some areas of the US, the incidence is 1 in 3,200 live births which would translate to an incidence of approximately three infants a day in the US (Brown, 2003). In other areas of the US, the incidence is even higher, approaching 1 in 1,500 liveborns (Whitley, personal communication, December 2002).

The current management guidelines recommended by ACOG (Guidelines for Perinatal Care, 2002) rely on history as a screening method to determine pregnant women who are at risk for transmitting herpes to their newborn. Based on data reported in NHANES III, history is an unreliable method of determining those who are infected with genital herpes (Fleming, 1997). Most importantly, history fails completely in identifying the women most at risk of transmitting herpes to their newborn - the seronegative woman who acquires a primary infection from her partner during pregnancy.

Since at-risk women can now be accurately identified by new and more accurate type-specific serologic tests, effective prevention strategies should be instituted to minimize risk of transmission to the neonate. The first obligation is to diagnose who is at risk. The highest risk is that of neonatal transmission from a mother experiencing a primary genital HSV-1 or HSV-2 infection in late pregnancy. Studies indicate that approximately 1.3% of women seroconvert during pregnancy and, among those who do, the risk of neonatal transmission is as high as 30 - 50% (Brown 1991). Conversely, the rate of neonatal transmission from women with recurrent genital herpes infection is low (<1%) (Brown, 1991, 1997; Smith, 1998; Arvin, 1986; Fonnest, 1997). However, since genital herpes is so common, the total number of cases of neonatal herpes from women with recurrent disease remains high (Fleming, 1997; STD Guidelines, 2002). Once a mother is identified as being infected with HSV-2, the health care providers - both pediatrician and obstetrician - can be alerted to the potential risk of neonatal herpes.

Management of pregnant women with or without herpes infections should include steps designed to minimize the risk of herpes transmission to neonates. This protocol examines patient acceptance of HSV-1 and HSV-2 type specific serologic testing and assesses patient counseling tools. In addition, seroprevalence of HSV-2 in pregnant patients will be collected and evaluated.

STUDY DESIGN

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant 24 weeks or less

排除标准

  • 未提供

结局指标

主要结局

% of patients willing to be tested

次要结局

  • Barriers to be tested for HSV

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验