HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Other: testing for HSV 1 and 2 IgG type specific antibosy |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women |
- % of patients willing to be tested [ Designated as safety issue: No ]
- Barriers to be tested for HSV [ Designated as safety issue: No ]
| Enrollment: | 300 |
| Study Start Date: | September 2005 |
| Study Completion Date: | September 2009 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
pregnant subjects
Inclusion Criteria:
- pregnant 24 weeks or less
Exclusion Criteria:
-
Contacts and Locations| United States, New York | |
| Dept ObGyn, 6 Tech Dr | |
| Stony Brook, New York, United States, 11794 | |
| Principal Investigator: | David A Baker, MD | Stony Brook University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00291044 History of Changes |
| Other Study ID Numbers: | VAL R116 |
| Study First Received: | February 9, 2006 |
| Last Updated: | November 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stony Brook University:
|
pregnancy, genital herpes |
Additional relevant MeSH terms:
|
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013