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Preeclampsia and Circulating Biomarkers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by University of Aarhus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02136667
First Posted: May 13, 2014
Last Update Posted: January 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Randers Regional Hospital
Karen Elise Jensen Foundation
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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.


Condition
Postpartum CVD Risk in Women With Previous Preeclampsia.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Circulating biomarkers of cardiovascular disease 10 years postpartum. [ Time Frame: 10 years postpartum ]

Secondary Outcome Measures:
  • Markers of arteriosclerosis and atherosclerosis [ Time Frame: 10 years postpartum ]
  • Circulating biomarkers of cardiovascular disease at baseline pregnancy. [ Time Frame: During pregnancy ]

Biospecimen Retention:   Samples With DNA
Blood serum Blood plasma Urine

Estimated Enrollment: 64
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposed
Women with a history of preeclampsia 10 years ago
Unexposed
Women with a history of uncomplicated pregnancy 10 years ago

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Participation in previous study 2001-2005.

Exclusion Criteria:

  • Current pregnancy or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136667


Locations
Denmark
Randers Regional Hospital Recruiting
Randers, Randers NØ, Denmark, 8930
Contact: Martin Christensen, MD    004578422354    marticis@rm.dk   
Principal Investigator: Martin Christensen, MD         
Sponsors and Collaborators
University of Aarhus
Randers Regional Hospital
Karen Elise Jensen Foundation
Central Denmark Region
Investigators
Study Chair: Ulla B Knudsen, Professor Department of Obstetrics and Gynaecology, Aarhus University Hospital
Principal Investigator: Martin Christensen, MD Clinical Research Unit, Randers Regional Hospital
Study Director: Camilla S Kronborg, MD, PhD Department of Oncology, Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02136667     History of Changes
Other Study ID Numbers: 98372017
First Submitted: May 1, 2014
First Posted: May 13, 2014
Last Update Posted: January 6, 2015
Last Verified: May 2014

Keywords provided by University of Aarhus:
Preeclampsia
Cardiovascular disease (CVD) risk

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications