Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing
Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00978848
Collaborator
Gen-Probe, Incorporated (Industry)
305
1
5
61.5
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis,
- 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
305 participants
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
Study Start Date
:
Nov 1, 2009
Actual Primary Completion Date
:
Apr 1, 2010
Actual Study Completion Date
:
Apr 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Women seeking emergency contraception Women seeking emergency contraception |
|
| Women seeking urine pregnancy testing Women seeking urine pregnancy testing |
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Harold Wiesenfeld,
Director, Division of Gynecologic Specialties & Division of Reproductive Infectious Diseases and Immunology,
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00978848
Other Study ID Numbers:
- PRO8120077
First Posted:
Sep 17, 2009
Last Update Posted:
May 18, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Harold Wiesenfeld,
Director, Division of Gynecologic Specialties & Division of Reproductive Infectious Diseases and Immunology,
University of Pittsburgh
Additional relevant MeSH terms: