Prospective Study in Pregnant Women With Hypercoagulopathy

February 1, 2006 updated by: Hillerod Hospital, Denmark

Prospective Study of Hypercoagulation in Pregnant Women

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anita S Andersen, MD
  • Phone Number: +45 4829 6828
  • Email: asan@fa.dk

Study Locations

  • Denmark
    • Frederiksborg
      • Hilleroed, Frederiksborg, Denmark, 3400
        • Recruiting
        • Department of Gynaecology and Obstetrics
        • Contact:
          • Jørgen G Berthelsen, MD
          • Phone Number: 4829 3707
          • Email: jgb@dadlnet.dk
    • Frederiksborg County
      • Hilleroed, Frederiksborg County, Denmark, 3400
        • Recruiting
        • Department of Gynaecology and Obstetrics, Hilleroed Hospital
        • Contact:
          • Jørgen G Berthelsen, MD
          • Phone Number: +45 4829 3707
          • Email: jgb@dadlnet.dk
        • Principal Investigator:
          • Anita S Andersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental disease.
  • Problems understanding or reading Danish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillerod Hospital, Denmark

Collaborators

Loyola University
Department of Clinical Trials, Denmark

Investigators

  • Principal Investigator: Anita S Andersen, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

October 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 2, 2006

Last Update Submitted That Met QC Criteria

February 1, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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