Preeclampsia and Circulating Biomarkers

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Aarhus
Sponsor:
Collaborators:
Randers Regional Hospital
Karen Elise Jensens Foundation
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02136667
First received: May 1, 2014
Last updated: May 8, 2014
Last verified: May 2014
  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: Case Control
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Markers of arteriosclerosis and atherosclerosis [ Time Frame: 10 years postpartum ] [ Designated as safety issue: No ]
  • Circulating biomarkers of cardiovascular disease at baseline pregnancy. [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood serum Blood plasma Urine


Estimated Enrollment: 64
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated 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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Jensens 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02136667     History of Changes
Other Study ID Numbers: 98372017
Study First Received: May 1, 2014
Last Updated: May 8, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 01, 2014