NCT00682201

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

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

August 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 6, 2011

Status Verified

June 1, 2009

Enrollment Period

1.8 years

First QC Date

May 20, 2008

Last Update Submit

July 3, 2011

Conditions

Pregnancy

Keywords

PregnancyBlood pressureCardiac output

Outcome Measures

Primary Outcomes (1)

  • Pregnancy specific changes in hemodynamic variables

    Normal pregnancy time frame

Secondary Outcomes (1)

  • Respiratory functional changes

    Normal pregnancy time frame

Study Arms (1)

1

Healthy pregnant women

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Pregnant women who at first admission are healthy

You may not qualify if:

  • Co-existing diseases who represents decreased physical or psychological function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet University Hospital, Division of Anesthesia and Critical Care Medicine

Oslo, 0027, Norway

Location

Study Officials

  • Leiv Arne Rosseland, PhD MD

    Rikshospitalet University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

August 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 6, 2011

Record last verified: 2009-06

Locations

NO(1)