Preeclampsia Subtypes and Surrogate Markers of CVD Risk

NCT02337049 | Unknown DMC

• 1 other identifier: 26702017
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies. Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008. Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.

Conditions

Preeclampsia

Keywords

Preeclampsia. Cardiovascular Disease (CVD) Risk.

Outcome Measures

Primary Outcomes (1)

• Echocardiographic Markers of Cardiac Strain

  10 years postpartum

Secondary Outcomes (2)

• Markers of arteriosclerosis and atherosclerosis

  10 years postpartum

• Circulating biomarkers of cardiovascular disease.

  10 years postpartum

Study Arms (3)

Previously early onset preeclampsia

Women with a history of early onset preeclampsia 10 years ago

Previously late onset preeclampsia

Women with a history of late onset preeclampsia 10 years ago

Previously normotensive pregnancy

Women with a history of normotensive pregnancies 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

Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008. Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.

You may qualify if:

• Women who delievered at the Department of Obstetrics at Randers Regional Hospital 1998-2008

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 Hos

  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
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 13, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

DK (1)