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HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

This study is currently recruiting participants.
Verified by Stony Brook University, September 2005

Sponsored by: Stony Brook University
Information provided by: Stony Brook University
ClinicalTrials.gov Identifier: NCT00291044
  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
Pregnancy

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Defined Population, Prospective Study
Official Title:   HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

Further study details as provided by Stony Brook University:

Estimated Enrollment:   300
Study Start Date:   September 2005

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • pregnant 24 weeks or less

Exclusion Criteria:

-

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291044

Contacts
Contact: David A. Baker, MD     631 444 2729     dbAKER2notes.cc.sunysb.edu    
Contact: Andrea Pressley, LPN     631 444 2758     apressley@notes.cc.sunysb.edu    

Locations
United States, New York
Dept ObGyn, 6 Tech Dr     Recruiting
      Stony Brook, New York, United States, 11794

Sponsors and Collaborators
Stony Brook University

Investigators
Principal Investigator:     David A Baker, MD     Stony Brook University    
  More Information


Publications:
Arvin AM, Hensleigh PA, Prober CG, et al. Failure of antepartum maternal cultures to predict the infant’s risk of exposure to herpes simplex virus at delivery. N Engl J Med 1986; 315:796-800. 2. Brown ZA, Benedetti J, Ashley R, et al. Neonatal herpes simplex virus infection in relation to asymptomatic maternal infection at the time of labor. N Engl J Med 1991; 324:1247-1252. 3. Brown ZA, Selke S, Zeh J, et al. The acquisition of herpes simplex virus during pregnancy. N Engl J Med 1997; 337:509-515. 4. Brown ZA, Wald A, Morrow RA, et al. Effect of Serologic Status and Cesarean Delivery on Transmission Rates of Herpes Simplex Virus from Mother to Infant. JAMA 2003; 289:203-209. 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.
 

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

Keywords provided by Stony Brook University:
pregnancy, genital herpes  

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Herpes Genitalis
Sexually Transmitted Diseases
DNA Virus Infections
Genital Diseases, Male
Herpesviridae Infections

ClinicalTrials.gov processed this record on October 31, 2008




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