Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005

This study has been completed.

Sponsor:

Information provided by:

Hillerod Hospital, Denmark

ClinicalTrials.gov Identifier:

NCT01176305

First received: August 5, 2010

Last updated: NA

Last verified: October 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	August 5, 2010
Last Updated Date	August 5, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: August 5, 2010)	Absolute incidence of thromboembolic event
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
Official Title ^ICMJE	Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
Brief Summary	The purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period.
Detailed Description	Venous thromboembolism (VTE) still causes maternal death in the western world. The purpose of this study is to estimate the relative and absolute risk of VTE at different gestational ages in pregnant women compared to non-pregnant women. All Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives are included.Non-pregnant women are controls.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives.
Condition ^ICMJE	Venous Thromboembolism
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Danish Women 15 to 49 years old. Free of previous VTE and current use of oral contraceptives.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Danish woman at 15 to 49 years old in the period January 1995 through December 2005. Free of previous VTE and current use of oral contraceptives. Exclusion Criteria: Previous VTE or current use of oral contraceptives.
Gender	Female
Ages	15 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01176305
Other Study ID Numbers ^ICMJE	RAV1
Has Data Monitoring Committee	Yes
Responsible Party	Thomas Bergholt, Hillerod Hospital, Gynecolocical-Obstetrical department
Study Sponsor ^ICMJE	Hillerod Hospital, Denmark
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hillerod Hospital, Denmark
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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