Left Ventricular and Endothelial Function in Preeclampsia | NCT00201500

Studies
Left Ventricular and Endothelial Function in Preeclampsia

NCT00201500

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 4, 2016Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Preeclampsia

Interventions

Not provided

Countries

Norway

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Dec 2005Actual

Completion Date

Mar 2006Actual

First Submitted Date

Sep 16, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 20, 2005Estimated

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

Aug 3, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Name	Class
Helse Nord-Trøndelag HF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
preeclampsia		women with preeclampsia
controls		healthy pregnant women

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left Ventricular Function		3 months
Endothelial Function		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women with preeclampsia and women with normotensive pregnancies.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stig A Slørdahl, Professor	Norwegian University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NTNU		Trondheim		N-7491	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21943052	Result	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.

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