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Prospective Study in Pregnant Women With Hypercoagulopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hillerod Hospital, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Department of Clinical Trials, Denmark
Loyola University
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00215969
First received: September 14, 2005
Last updated: February 1, 2006
Last verified: September 2005
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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
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            
Department of Gynaecology and Obstetrics Recruiting
Hilleroed, Frederiksborg, Denmark, 3400
Contact: Jørgen G Berthelsen, MD     4829 3707     jgb@dadlnet.dk    
Sponsors and Collaborators
Hillerod Hospital, Denmark
Department of Clinical Trials, Denmark
Loyola University
Investigators
Principal Investigator: Anita S Andersen, MD
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on May 22, 2013