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Prospective Study in Pregnant Women With Hypercoagulopathy
This study is currently recruiting participants.
Verified by Hillerod Hospital, Denmark, September 2005
Sponsors and Collaborators: Hillerod Hospital, Denmark
Department of Clinical Trials, Denmark
Loyola University
Information provided by: Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00215969
  Purpose

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.


Condition
Pre-Eclampsia
Eclampsia

U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Case Control, Prospective Study
Official Title: Prospective Study of Hypercoagulation in Pregnant Women

Further study details as provided by Hillerod Hospital, Denmark:

Estimated Enrollment: 600
Study Start Date: January 2004
Estimated Study Completion Date: October 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental disease.
  • Problems understanding or reading Danish.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215969

Contacts
Contact: Anita S Andersen, MD +45 4829 6828 asan@fa.dk

Locations
Denmark, Frederiksborg
Department of Gynaecology and Obstetrics Recruiting
Hilleroed, Frederiksborg, Denmark, 3400
Contact: Jørgen G Berthelsen, MD     4829 3707     jgb@dadlnet.dk    
Denmark, Frederiksborg County
Department of Gynaecology and Obstetrics, Hilleroed Hospital Recruiting
Hilleroed, Frederiksborg County, Denmark, 3400
Contact: Jørgen G Berthelsen, MD     +45 4829 3707     jgb@dadlnet.dk    
Principal Investigator: Anita S Andersen, MD            
Sponsors and Collaborators
Hillerod Hospital, Denmark
Department of Clinical Trials, Denmark
Loyola University
Investigators
Principal Investigator: Anita S Andersen, MD Unaffiliated
  More Information

Study ID Numbers: PR0104
Study First Received: September 14, 2005
Last Updated: February 1, 2006
ClinicalTrials.gov Identifier: NCT00215969  
Health Authority: Denmark: Danish Dataprotection Agency;   Denmark: Ethics Committee

Keywords provided by Hillerod Hospital, Denmark:
Pre-eclampsia
Pregnancy
Hypercoagulation
Screening
Cardiovascular complications

Study placed in the following topic categories:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pregnancy toxemia /hypertension
Pre-Eclampsia
Preeclampsia
Hypertension

ClinicalTrials.gov processed this record on January 14, 2009