Hemodynamic Changes During Normal Pregnancy | NCT00682201

Studies
Hemodynamic Changes During Normal Pregnancy

NCT00682201

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Pregnancy

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

Jun 2009

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

Aug 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

May 20, 2008

First Submission Date that Met QC Criteria

May 21, 2008

First Posted Date

May 22, 2008Estimated

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

Jul 3, 2011

Last Update Posted Date

Jul 6, 2011Estimated

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

Prospective, observational study of the changes in hemodynamic variables such as blood pressure, cardiac output, systemic vascular resistance, and of changes in respiratory variables such as vital capacity, and functional residual volume.A cohort study of 100 healthy pregnant women tested with non-invasive methods during pregnancy and 6 months after delivery.

Detailed Description

Healthy pregnant women with the willingness to consent in physiologic tests at 3 different time points during, and one time point after pregnancy. Spirometric tests will be performed with V-MAX, non-invasive measuring of hemodynamics will be measured by Finometer.

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

No data available

No data is available for this block.

Enrollment

120Estimated

Label	Type	Description	Intervention Names
1		Healthy pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy specific changes in hemodynamic variables		Normal pregnancy time frame

Secondary Outcomes

Measure	Description	Time Frame
Respiratory functional changes		Normal pregnancy time frame

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women who at first admission are healthy

Exclusion Criteria:

Co-existing diseases who represents decreased physical or psychological function

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Healty pregnant women scheduled for delivery at the Birth Clinic, Rikshospitalet University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leiv Arne Rosseland, PhD MD	Rikshospitalet University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rikshospitalet University Hospital, Division of Anesthesia and Critical Care Medicine		Oslo		0027	Norway