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Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978848
First Posted: September 17, 2009
Last Update Posted: May 18, 2016
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.
Collaborator:
Gen-Probe, Incorporated
Information provided by (Responsible Party):
Harold Wiesenfeld, University of Pittsburgh
  Purpose
The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine STD test.

Condition
Trichomonas Vaginitis Chlamydia Trachomatis Neisseria Gonorrhoeae Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population

Resource links provided by NLM:


Further study details as provided by Harold Wiesenfeld, University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA
Any left over urine may be frozen for future use on infections in women

Enrollment: 305
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women seeking emergency contraception
Women seeking emergency contraception
Women seeking urine pregnancy testing
Women seeking urine pregnancy testing

Detailed Description:
This study has three primary objectives: 1) to determine the prevalence of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing - a population likely at increased risk of acquiring STDs; 2) to determine the rate of successful treatment in women diagnosed with STDs in this venue.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing
Criteria

Inclusion Criteria:

  • Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Diagnosis and/or treatment for an STD within 4 weeks of enrollment in the study.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00978848


Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Gen-Probe, Incorporated
Investigators
Principal Investigator: Harold C Wiesenfeld, MD, CM University of Pittsburgh
  More Information

Responsible Party: Harold Wiesenfeld, Director, Division of Gynecologic Specialties & Division of Reproductive Infectious Diseases and Immunology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00978848     History of Changes
Other Study ID Numbers: PRO8120077
First Submitted: September 16, 2009
First Posted: September 17, 2009
Last Update Posted: May 18, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Harold Wiesenfeld, University of Pittsburgh:
trichomonas
chlamydia
gonorrhea
emergency contraception
emergency contraception use

Additional relevant MeSH terms:
Emergencies
Chlamydia Infections
Sexually Transmitted Diseases
Gonorrhea
Vaginitis
Trichomonas Infections
Trichomonas Vaginitis
Disease Attributes
Pathologic Processes
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases
Neisseriaceae Infections
Vaginal Diseases
Protozoan Infections
Parasitic Diseases


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