Randomized Population-Based Study on Chlamydia Trachomatis Screening

This study has been completed.
Sponsor:
Collaborators:
Aarhus County, Denmark
Novo foundation
The Danish Medical Research Council
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00827970
First received: January 22, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 24 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: January 22, 2009
Last Updated: January 22, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
mass screening

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications
Chlamydia Infections
Infertility
Cardiac Complexes, Premature
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014