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Randomized Population-Based Study on Chlamydia Trachomatis Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827970
First Posted: January 23, 2009
Last Update Posted: January 23, 2009
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.
Collaborators:
Aarhus County, Denmark
Novo foundation
The Danish Medical Research Council
Information provided by:
University of Aarhus
  Purpose

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.


Condition Intervention
Chlamydia Trachomatis Infertility Ectopic Pregnancy Behavioral: Screening for urogenital Chlamydia trachomatis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Long term infertility complications [ Time Frame: 2008 ]

Enrollment: 30000
Study Start Date: October 1997
Study Completion Date: August 2007
Primary Completion Date: February 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Screening
Individuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
Behavioral: Screening for urogenital Chlamydia trachomatis
Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
No Intervention: 2 Control
Control group receiving usual care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • born in 1974, 1974 or 1976 AND living in Aarhus County October 1007

Exclusion Criteria:

  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): NCT00827970


Locations
Denmark
Department of Infectious Diseases, Aarhus University Hospital Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus County, Denmark
Novo foundation
The Danish Medical Research Council
Investigators
Principal Investigator: Berit Andersen, MD, Ph.D. Aarhus University Hospital Skejby, Department of Infectious Diseases
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berit Andersen, MD, Ph.D., Aarhus University Hospital Skejby, Department of Infectious Diseases
ClinicalTrials.gov Identifier: NCT00827970     History of Changes
Other Study ID Numbers: Cesoirs01
First Submitted: January 22, 2009
First Posted: January 23, 2009
Last Update Posted: January 23, 2009
Last Verified: January 2009

Keywords provided by University of Aarhus:
mass screening

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications
Infertility
Chlamydia Infections
Genital Diseases, Male
Genital Diseases, Female
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection