Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture
Public ClinicalTrials.gov record NCT01878383. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Device Trial: Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PCR detection of HSV DNA shedding in the female genital tract using the GeneXpert system (Cepheid, Sunnyvale CA) will be compared with traditional (routine) PCR (pregnant and nonpregnant women) and with HSV culture (nonpregnant women). The GeneXpert system performs all sample-processing steps and real-time PCR in a single integrated cartridge. The standard cartridge is an inexpensive disposable plastic cartridge with filtration and ultrasonic lysis capabilities. It consists chiefly of several combined molded plastic components: a cartridge body containing eleven fluid reservoirs or chambers along with an attached PCR tube, a specialized valve body with an ultrasonic interface containing a sub-micron filter and glass lysis beads, and a rotary valve with an axial syringe barrel. The operation of the cartridge is simple. The rotary valve contains an inlet and an outlet port. Fluid such as a sample buffer can be drawn up into a syringe drive through the inlet port of the rotary valve and then dispensed into any other chamber within the cartridge by rotating the valve and expelling the fluid through the outlet port. The fluid can either be passed through a filter contained within the valve assembly or it can be passed directly into the next chamber without filtration, depending on the path that is chosen. The cartridge fluidics and subsequent real-time PCR all are performed within the GeneXpert instrument. The GeneXpert contains multiple modules (ICORE units) that can be independently programmed to drive the syringe/rotary valve, and to perform four-color real-time PCR. Each cartridge fits inside one module, and all processing, PCR, and analysis steps are performed automatically. Each ICORE module can be run and analyzed independently, so batching of samples is unnecessary.
Study identification
- NCT ID
- NCT01878383
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 12,550 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2013
- Primary completion
- Dec 30, 2019
- Completion
- Dec 30, 2019
- Last update posted
- Sep 8, 2020
2014 – 2019
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72202 | — |
| University of Colorado at Denver Health Sciences Center | Aurora | Colorado | 80045 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Emory Children's Center | Atlanta | Georgia | 30322 | — |
| Louisiana State University Health Science Center-Shreveport | Shreveport | Louisiana | 71103 | — |
| Washington University in St Louis School of Medicine | St Louis | Missouri | 63110 | — |
| Dartmouth Medical School | Lebanon | New Hampshire | 03756 | — |
| Steven & Alexandra Cohen Children's Medical Center of New York (CCMC) | Manhasset | New York | 11030 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Carolinas Medical Center - Charlotte | Charlotte | North Carolina | 28203 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Nationwide Children Hospital | Columbus | Ohio | 43205-2664 | — |
| McGee Women's Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
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 NCT01878383, 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 Sep 8, 2020 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01878383 live on ClinicalTrials.gov.