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| Sponsors and Collaborators: |
University of Aarhus Aarhus County Novo foundation The Danish Medical Research Council |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00827970 |
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: | Screening, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study |
| 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 |
|---|---|
|
1 Screening: Experimental
Individuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
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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.
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2 Control: No Intervention
Control group receiving usual care
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Eligibility| Ages Eligible for Study: | 21 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and Locations| Denmark | |
| Department of Infectious Diseases, Aarhus University Hospital Skejby | |
| Aarhus N, Denmark, 8200 | |
| Principal Investigator: | Berit Andersen, MD, Ph.D. | Aarhus University Hospital Skejby, Department of Infectious Diseases |
More Information
| Responsible Party: | Aarhus University Hospital Skejby, Department of Infectious Diseases ( Berit Andersen, MD, Ph.D. ) |
| Study ID Numbers: | Cesoirs01 |
| Study First Received: | January 22, 2009 |
| Last Updated: | January 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00827970 History of Changes |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee |
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mass screening |
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Genital Diseases, Female Bacterial Infections Infertility Pregnancy Complications Pregnancy, Ectopic Sexually Transmitted Diseases |
Chlamydia Infections Ectopic Pregnancy Genital Diseases, Male Cardiac Complexes, Premature Gram-Negative Bacterial Infections |
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Genital Diseases, Female Bacterial Infections Sexually Transmitted Diseases, Bacterial Infertility Pregnancy Complications Chlamydiaceae Infections |
Pregnancy, Ectopic Sexually Transmitted Diseases Chlamydia Infections Genital Diseases, Male Infection Gram-Negative Bacterial Infections |
