Preeclampsia and Circulating Biomarkers | NCT02136667

Studies
Preeclampsia and Circulating Biomarkers

NCT02136667

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Jan 6, 2015Estimated

Enrollment

64Estimated

Phase

Not provided

Conditions

Postpartum CVD Risk in Women With Previous Preeclampsia.

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2015Estimated

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

May 8, 2014

First Posted Date

May 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2015

Last Update Posted Date

Jan 6, 2015Estimated

Name	Class
Randers Regional Hospital	OTHER
Karen Elise Jensen Foundation	OTHER
Central Denmark Region	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed		Women with a history of preeclampsia 10 years ago
Unexposed		Women with a history of uncomplicated pregnancy 10 years ago

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circulating biomarkers of cardiovascular disease 10 years postpartum.		10 years postpartum

Secondary Outcomes

Measure	Description	Time Frame
Markers of arteriosclerosis and atherosclerosis		10 years postpartum
Circulating biomarkers of cardiovascular disease at baseline pregnancy.		During pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participation in previous study 2001-2005.

Exclusion Criteria:

Current pregnancy or breastfeeding

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Randers Regional Hospital	Recruiting	Randers	Randers NØ	8930	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided