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NCT00291044 · ClinicalTrials.gov registry record
HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women
A clinical trial, sponsored by Stony Brook University.
- Completed
- Registry status
- 300
- Enrollment target
NCT00291044 is a clinical trial that has completed, run by Stony Brook University. The registered enrollment target is 300 participants.
The verdict
NCT00291044 has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study 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.
Interventions
- OTHER testing for HSV 1 and 2 IgG type specific antibosy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00291044
The ClinicalTrials.gov registry entry for NCT00291044 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which testing for HSV 1 and 2 IgG type specific antibosy is the first listed.
NCT00291044 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00291044 about?
NCT00291044 is a clinical study titled "HSV Seroprevalence and Diagnosis of Genital Herpes in Pregnant Women". 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 - th...
What is the current status of trial NCT00291044?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2005-09. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00291044?
The interventions under investigation include: testing for HSV 1 and 2 IgG type specific antibosy (OTHER).
Who is sponsoring clinical trial NCT00291044?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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