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Prospective Study in Pregnant Women With Hypercoagulopathy

NCT ID: NCT00215969

Last Updated: 2006-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pre-Eclampsia Eclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Mental disease.
* Problems understanding or reading Danish.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Clinical Trials, Denmark

OTHER_GOV

Sponsor Role collaborator

Loyola University

OTHER

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Anita S Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Department of Gynaecology and Obstetrics, Hilleroed Hospital

Hilleroed, Frederiksborg County, Denmark

Site Status RECRUITING

Department of Gynaecology and Obstetrics

Hilleroed, Frederiksborg, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anita S Andersen, MD

Role: CONTACT

[email protected]
+45 4829 6828

Facility Contacts

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Jørgen G Berthelsen, MD

Role: primary

[email protected]
+45 4829 3707

Jørgen G Berthelsen, MD

Role: primary

[email protected]
4829 3707

Other Identifiers

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PR0104

Identifier Type: -

Identifier Source: org_study_id