NCT00201500

Brief Summary

The purpose of this study is (1) to examine whether the left ventricular function is impaired in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the endothelial function is impaired in women with preeclampsia relative to healthy pregnant controls, and (3) to examine whether there is a post partum impairment in left ventricular and endothelial function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

September 16, 2005

Last Update Submit

August 3, 2016

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (2)

  • Left Ventricular Function

    3 months

  • Endothelial Function

    3 months

Study Arms (2)

preeclampsia

women with preeclampsia

controls

healthy pregnant women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women with preeclampsia and women with normotensive pregnancies.

You may qualify if:

  • \>18 years of age
  • Case: Clinical diagnosis of preeclampsia,
  • Control: Systolic BP \<140 mmHg and diastolic BP \<90 mmHg

You may not qualify if:

  • Known hypertension or other cardiovascular disease
  • Diabetes/gestational diabetes
  • Multiple gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTNU

Trondheim, N-7491, Norway

Location

Related Publications (1)

  • Tyldum EV, Backe B, Stoylen A, Slordahl SA. Maternal left ventricular and endothelial functions in preeclampsia. Acta Obstet Gynecol Scand. 2012 May;91(5):566-73. doi: 10.1111/j.1600-0412.2011.01282.x.

    PMID: 21943052RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Stig A Slørdahl, Professor

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2005

Study Completion

March 1, 2006

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

NO(1)