Clinical Trial: HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

Brief Summary: 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.

Detailed Summary:

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 ne
Sponsor: Stony Brook University

Current Primary Outcome: % of patients willing to be tested

Original Primary Outcome:

Current Secondary Outcome: Barriers to be tested for HSV

Original Secondary Outcome:

Information By: Stony Brook University

Dates:
Date Received: February 9, 2006
Date Started: September 2005
Date Completion:
Last Updated: November 18, 2010
Last Verified: November 2010