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NCT00215969 Clinical Trial

Prospective Study in Pregnant Women With Hypercoagulopathy

Pre-Eclampsia Clinical Trial

Official title:
Prospective Study of Hypercoagulation in Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00215969
Other study ID # PR0104
Secondary ID
Status Recruiting
Phase N/A
First received September 14, 2005
Last updated February 1, 2006
Start date January 2004
Est. completion date October 2007

Study information
Verified date September 2005
Source Hillerod Hospital, Denmark
Contact Anita S Andersen, MD
Phone +45 4829 6828
Email asan@fa.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Observational

Clinical Trial Summary

Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. The aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening.

Description:

600 pregnant women will be included in the project and followed in a standardized manner during their pregnancy. On a regular basis blood- and urine samples will be taken throughout their pregnancy and until 1 month after delivery and analyzed for a large variety of coagulation factors in order to identify factors that might predict an increased risk of developing pre-eclampsia and/or cardiovascular events. In addition a DNA-sample is taken if consented in order to evaluate genetic factors.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnant women attending the midwife at Hilleroed Hospital, Frederiksborg County, Denmark.

Exclusion Criteria:

- Mental disease.

- Problems understanding or reading Danish.

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Gynaecology and Obstetrics Hilleroed Frederiksborg
Denmark Department of Gynaecology and Obstetrics, Hilleroed Hospital Hilleroed Frederiksborg County

Sponsors (3)
Lead Sponsor Collaborator
Hillerod Hospital, Denmark Department of Clinical Trials, Denmark, Loyola University

Country where clinical trial is conducted

Denmark, 

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