Working… Menu
Trial record 75 of 126 for:    HSV-2

HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291044
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : November 19, 2010
Information provided by:
Stony Brook University

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.

Condition or disease Intervention/treatment
Pregnancy Other: testing for HSV 1 and 2 IgG type specific antibosy

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women
Study Start Date : September 2005
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

Primary Outcome Measures :
  1. % of patients willing to be tested

Secondary Outcome Measures :
  1. Barriers to be tested for HSV

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pregnant subjects

Inclusion Criteria:

  • pregnant 24 weeks or less

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291044

Layout table for location information
United States, New York
Dept ObGyn, 6 Tech Dr
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Layout table for investigator information
Principal Investigator: David A Baker, MD Stony Brook University

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.

Layout table for additonal information Identifier: NCT00291044     History of Changes
Other Study ID Numbers: VAL R116
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010
Keywords provided by Stony Brook University:
pregnancy, genital herpes
Additional relevant MeSH terms:
Layout table for 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