Preeclampsia and Circulating Biomarkers

Postpartum CVD Risk in Women With Previous Preeclampsia. Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02136667
• Other study ID #: 98372017
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2014
• Last updated: January 5, 2015
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

In order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year follow-up study comparing 32 exposed (women with a history of pregnancy complicated by preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy).

Participants will be recruited from a well-characterised cohort, previously assembled during their pregnancies, at the Department of Obstetrics at Randers Regional Hospital in 2001-2004.

Blood and urine samples, collected during their pregnancies, are stored in a biobank, thus rendering the possibility of longitudinal assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participation in previous study 2001-2005.

Exclusion Criteria:

• Current pregnancy or breastfeeding

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Postpartum CVD Risk in Women With Previous Preeclampsia.
• Pre-Eclampsia

Locations

Country	Name	City	State
Denmark	Randers Regional Hospital	Randers	Randers NØ

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region, Karen Elise Jensen Foundation, Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating biomarkers of cardiovascular disease 10 years postpartum.		10 years postpartum	No
Secondary	Markers of arteriosclerosis and atherosclerosis		10 years postpartum	No
Secondary	Circulating biomarkers of cardiovascular disease at baseline pregnancy.		During pregnancy	No