HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

This study has been completed.
Sponsor:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00291044
First received: February 9, 2006
Last updated: November 18, 2010
Last verified: November 2010
  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

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • % of patients willing to be tested [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

pregnant subjects

Criteria

Inclusion Criteria:

  • pregnant 24 weeks or less

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Dept ObGyn, 6 Tech Dr
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.

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 September 30, 2014