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Sponsored by: |
Stony Brook University |
Information provided by: | Stony Brook University |
ClinicalTrials.gov Identifier: | NCT00291044 |
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 |
Pregnancy |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-
Contact: David A. Baker, MD | 631 444 2729 | dbAKER2notes.cc.sunysb.edu |
Contact: Andrea Pressley, LPN | 631 444 2758 | apressley@notes.cc.sunysb.edu |
United States, New York | |||||
Dept ObGyn, 6 Tech Dr | Recruiting | ||||
Stony Brook, New York, United States, 11794 |
Stony Brook University |
Principal Investigator: | David A Baker, MD | Stony Brook University |
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5. Fleming DT, McQuillan GM, Johnson RE, et al. Herpes simplex virus type 2 in the United States, 1976 to 1994. N Engl J Med 1997; 337:1105-1111.
6. Fonnest G, de la Fuente Fonnest I, Weber T. Neonatal herpes in Denmark 1977-1991. Acta Obstet Gynecol Scand 1997; 76:355-358.
7. Guidelines for Perinatal Care: AAP, ACOG, 2002. pp. 292-297.
8. Sexually Transmitted Disease Treatment Guidelines 2002. MMWR 2002; 51:12-
9. Smith JR, Cowan FM, Munday P. The management of herpes simplex virus infection in pregnancy. Br J Obstet Gynaecol 1998; 105:255-260.
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Study ID Numbers: | VAL R116 |
First Received: | February 9, 2006 |
Last Updated: | February 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00291044 |
Health Authority: | United States: Institutional Review Board |
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