Hemodynamic Changes During Normal Pregnancy - Full Text View

Sponsor:	Rikshospitalet HF
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00682201

Purpose

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.

Condition
Pregnancy

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Hemodynamic Changes During Normal Pregnancy: A Prospective Cohort Study of 100 Healthy Pregnant Women

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	August 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Healthy pregnant women

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

Pregnant women who at first admission are healthy

Exclusion Criteria:

Co-existing diseases who represents decreased physical or psychological function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682201

Locations

Norway
Rikshospitalet University Hospital, Division of Anesthesia and Critical Care Medicine
Oslo, Norway, 0027

Sponsors and Collaborators

Rikshospitalet HF

Investigators

Study Director:

Leiv Arne Rosseland, PhD MD

Rikshospitalet University Hospital

More Information

No publications provided

Responsible Party:	Rikshospitalet University Hospital, Oslo, Norway ( Øyvind Skraastad, Head of The Division of Anaesthesia and Intensive Care Medicine )
Study ID Numbers:	storkhemo-08-GG
Study First Received:	May 20, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00682201 History of Changes
Health Authority:	Norway: Data Inspectorate

Keywords provided by Rikshospitalet HF:

Pregnancy
Blood pressure
Cardiac output

ClinicalTrials.gov processed this record on November 30, 2009