Hemodynamic Changes During Normal Pregnancy - Full Text View

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

U.S. FDA Resources

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-Radiumhospitalet 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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 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

Contacts


Contact: Guro Grindheim, MD	47-2307-3700	guro.grindheim@rikshospitalet.no

Contact: Leiv Arne Rosseland, PhD MD	47-2307-3700	l.a.rosseland@medisin.uio.no

Locations


Norway
	Rikshospitalet University Hospital, Division of Anesthesia and Critical Care Medicine	Recruiting
	Oslo, Norway, 0027
	Contact: Øyvind Skraastad, PhD MD 47-2307-1838 oyvind.skraastad@rikshospitalet.no
	Contact: Harald P Breivik, MD PhD 47-2307-3691 harald.breivik@medisin.uio.no
	Principal Investigator: Guro Grindheim, MD
	Sub-Investigator: Eldrid Langesæter, MD
	Sub-Investigator: Leiv Arne Rosseland, PhD MD
	Sub-Investigator: Audun Stubhaug, PhD MD

Sponsors and Collaborators

Rikshospitalet-Radiumhospitalet HF

Investigators


Study Director:	Leiv Arne Rosseland, PhD MD	Rikshospitalet University Hospital

More Information

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
First Received:	May 20, 2008
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00682201
Health Authority:	Norway: Data Inspectorate

Keywords provided by Rikshospitalet-Radiumhospitalet HF:

Pregnancy

Blood pressure

Cardiac output

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Rikshospitalet-Radiumhospitalet HF
Information provided by:	Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier:	NCT00682201