Back to resultsRandomized Population-Based Study on Chlamydia Trachomatis Screening
Primary Purpose
Chlamydia Trachomatis, Infertility, Ectopic Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Screening for urogenital Chlamydia trachomatis
Sponsored by
About this trial
This is an interventional screening trial for Chlamydia Trachomatis focused on measuring mass screening
Eligibility Criteria
Inclusion Criteria:
- born in 1974, 1974 or 1976 AND living in Aarhus County October 1007
Exclusion Criteria:
-
Sites / Locations
- Department of Infectious Diseases, Aarhus University Hospital Skejby
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1 Screening
2 Control
Arm Description
Individuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
Control group receiving usual care
Outcomes
Primary Outcome Measures
Long term infertility complications
Secondary Outcome Measures
Full Information
NCT ID
NCT00827970
First Posted
January 22, 2009
Last Updated
January 22, 2009
Sponsor
University of Aarhus
Collaborators
Aarhus County, Denmark, Novo foundation, The Danish Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00827970
Brief Title
Randomized Population-Based Study on Chlamydia Trachomatis Screening
Official Title
Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
February 1998 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus County, Denmark, Novo foundation, The Danish Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.
The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis, Infertility, Ectopic Pregnancy
Keywords
mass screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Screening
Arm Type
Experimental
Arm Description
Individuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
Arm Title
2 Control
Arm Type
No Intervention
Arm Description
Control group receiving usual care
Intervention Type
Behavioral
Intervention Name(s)
Screening for urogenital Chlamydia trachomatis
Intervention Description
Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
Primary Outcome Measure Information:
Title
Long term infertility complications
Time Frame
2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
born in 1974, 1974 or 1976 AND living in Aarhus County October 1007
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Andersen, MD, Ph.D.
Organizational Affiliation
Aarhus University Hospital Skejby, Department of Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases, Aarhus University Hospital Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
11807700
Citation
Andersen B, Olesen F, Moller JK, Ostergaard L. Population-based strategies for outreach screening of urogenital Chlamydia trachomatis infections: a randomized, controlled trial. J Infect Dis. 2002 Jan 15;185(2):252-8. doi: 10.1086/338268. Epub 2002 Jan 3.
Results Reference
result
PubMed Identifier
21097811
Citation
Andersen B, van Valkengoed I, Sokolowski I, Moller JK, Ostergaard L, Olesen F. Impact of intensified testing for urogenital Chlamydia trachomatis infections: a randomised study with 9-year follow-up. Sex Transm Infect. 2011 Mar;87(2):156-61. doi: 10.1136/sti.2010.042192. Epub 2010 Nov 20.
Results Reference
derived
Learn more about this trial
Randomized Population-Based Study on Chlamydia Trachomatis Screening
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