Hemodynamic Changes During Normal Pregnancy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 20, 2008

Last Updated Date

June 23, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pregnancy specific changes in hemodynamic variables [ Time Frame: Normal pregnancy time frame ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00682201 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Respiratory functional changes [ Time Frame: Normal pregnancy time frame ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Hemodynamic Changes During Normal Pregnancy

Official Title ^ICMJE

Hemodynamic Changes During Normal Pregnancy: A Prospective Cohort Study of 100 Healthy Pregnant Women

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Pregnancy

Intervention ^ICMJE

Study Arms / Comparison Groups

Healthy pregnant women

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pregnant women who at first admission are healthy

Exclusion Criteria:

Co-existing diseases who represents decreased physical or psychological function

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00682201

Responsible Party

Øyvind Skraastad, Head of The Division of Anaesthesia and Intensive Care Medicine, Rikshospitalet University Hospital, Oslo, Norway

Study ID Numbers ^ICMJE

storkhemo-08-GG

Study Sponsor ^ICMJE

Rikshospitalet HF

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Leiv Arne Rosseland, PhD MD

Rikshospitalet University Hospital

Information Provided By

Rikshospitalet HF

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP