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Completed No phase listed Observational Accepts healthy volunteers

HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women

ClinicalTrials.gov ID: NCT00291044

Public ClinicalTrials.gov record NCT00291044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 16, 2026, 3:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00291044
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Stony Brook University
Other
Enrollment
300 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2005
Primary completion
Not listed
Completion
Aug 31, 2009
Last update posted
Nov 18, 2010

2005 – 2009

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Dept ObGyn, 6 Tech Dr Stony Brook New York 11794

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00291044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 18, 2010 · Synced Sep 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00291044 live on ClinicalTrials.gov.

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