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Prospective Study in Pregnant Women With Hypercoagulopathy

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ClinicalTrials.gov Identifier: NCT00215969
Recruitment Status : Unknown
Verified September 2005 by Hillerod Hospital, Denmark.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : February 2, 2006
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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.

Condition or disease
Pre-Eclampsia Eclampsia

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.

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prospective Study of Hypercoagulation in Pregnant Women
Study Start Date : January 2004
Estimated Study Completion Date : October 2007


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00215969     History of Changes
Other Study ID Numbers: PR0104
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 2, 2006
Last Verified: September 2005

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