Preeclampsia Subtypes and Surrogate Markers of CVD Risk

January 8, 2015 updated by: University of Aarhus

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Randers NØ
      • Randers, Randers NØ, Denmark, 8930
        • Recruiting
        • Randers Regional Hospital
        • Contact:
          • Martin Christensen, MD
          • Phone Number: 004578422354
          • Email: marticis@rm.dk
        • Principal Investigator:
          • Martin Christensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Current pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Echocardiographic Markers of Cardiac Strain
Time Frame: 10 years postpartum
10 years postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Markers of arteriosclerosis and atherosclerosis
Time Frame: 10 years postpartum
10 years postpartum
Circulating biomarkers of cardiovascular disease.
Time Frame: 10 years postpartum
10 years postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Central Denmark Region
Karen Elise Jensen Foundation
Randers Regional Hospital

Investigators

  • Study Chair: Ulla B Knudsen, Professor, Department of Obstetrics and Gynaecology, Aarhus University Hos
  • Principal Investigator: Martin Christensen, MD, Clinical Research Unit, Randers Regional Hospital
  • Study Director: Camilla S Kronborg, MD, PhD, Department of Oncology, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 8, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 8, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26702017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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