Preeclampsia and Circulating Biomarkers

NCT02136667 | Unknown DMC

• 1 other identifier: 98372017
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum CVD Risk in Women With Previous Preeclampsia.

Keywords

Preeclampsia; Cardiovascular disease (CVD) risk

Outcome Measures

Primary Outcomes (1)

• Circulating biomarkers of cardiovascular disease 10 years postpartum.

  10 years postpartum

Secondary Outcomes (2)

• Markers of arteriosclerosis and atherosclerosis

  10 years postpartum

• Circulating biomarkers of cardiovascular disease at baseline pregnancy.

  During pregnancy

Study Arms (2)

Exposed

Women with a history of preeclampsia 10 years ago

Unexposed

Women with a history of uncomplicated pregnancy 10 years ago

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from a well-characterised cohort, previously assembled at the Department of Obstetrics at Randers Regional Hospital in 2001-2005.

You may qualify if:

• Participation in previous study 2001-2005.

You may not qualify if:

• Current pregnancy or breastfeeding

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator
• Karen Elise Jensen Foundation: collaborator
• Central Denmark Region: collaborator

Study Sites (1)

Randers Regional Hospital

Randers, Randers NØ, 8930, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum Blood plasma Urine

MeSH Terms

Conditions

Pre-Eclampsia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ulla B Knudsen, Professor

  Department of Obstetrics and Gynaecology, Aarhus University Hospital

  STUDY CHAIR

• Martin Christensen, MD

  Clinical Research Unit, Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

• Camilla S Kronborg, MD, PhD

  Department of Oncology, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 13, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 6, 2015

Record last verified: 2014-05

Locations

DK (1)