Prospective Study in Pregnant Women With Hypercoagulopathy

• Conditions: Pre-Eclampsia; Eclampsia

• Registration Number: NCT00215969
• Lead Sponsor: Hillerod Hospital, Denmark

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.

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 Timeline

• Study Start: 2004-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Last Update Submitted: 2006-02-01
• Last Update Posted: 2006-02-02
• Study Completion: 2007-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• Mental disease.
• Problems understanding or reading Danish.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Department of Gynaecology and Obstetrics, Hilleroed Hospital; 🇩🇰 Hilleroed, Frederiksborg County, Denmark

Department of Gynaecology and Obstetrics; 🇩🇰 Hilleroed, Frederiksborg, Denmark