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Fetal Aortic Pulsewave Velocity: A Novel Doppler Ultrasound Method of Measuring the Biophysical Properties of the Fetal Aorta

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ClinicalTrials.gov Identifier: NCT00359034
Recruitment Status : Withdrawn (Could not resolve technical difficulties)
First Posted : August 1, 2006
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Study Description
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Brief Summary:

We are interested in determining if we can measure the blood flow in the descending aorta (large blood vessel in the abdomen) of healthy fetuses and fetuses with growth restriction. An increasing number of adult diseases (e.g. heart and blood vessel disease) are recognized as potentially associated with fetal growth and development.

Pulse wave velocity (PWV) is a measure of blood flow in blood vessels. This is routinely measured in adults, and has recently been studied in children. The purpose of our study is to see if we can develop a simple ultrasound method to measure the PWV in fetuses.

The purpose of this study is to see if we can consistently measure the blood flow patterns in the fetal descending aorta (large blood vessel in the abdomen) of 20 healthy fetuses and 20 growth restricted fetuses using standard ultrasound techniques.


Condition or disease
Healthy

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Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Aortic Pulsewave Velocity: A Novel Doppler Ultrasound Method of Measuring the Biophysical Properties of the Fetal Aorta
Study Start Date : May 2006
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Singleton pregnancy between 20-36 weeks GA presenting at British Columbia Women's Hospital.
Criteria

Inclusion Criteria:

Study Group N:

Singleton pregnancy between 20 weeks 0 days and 36 weeks 0 days Normal obstetrical ultrasound in DAP at BCWH between 20-36 weeks GA

Study Group IUGR:

Singleton pregnancy between 20 weeks 0 days and 36 weeks 0 days Obstetrical ultrasound in DAP at BCWH between 20-36 weeks GA demonstrating IUGR (abdominal circumference AC <10%) and one of: a)oligohydramnios (amniotic fluid index (AFI) <5%) or b)abnormal umbilical artery (UA) Dopplers (absent or reversed end-diastolic flow)

Exclusion Criteria:

Study Group N:

Gestational age <20 weeks or ≥36 weeks Multiple pregnancy Any known or suspected fetal structural anomaly (including cardiac) Chromosomal abnormalities (on amniocentesis or CVS) Abnormalities in fetal growth (AC <10%; AC >90%) Abnormalities in amniotic fluid volume (AFI <5% or >95%) Maternal hypertensive disorder (during or prior to pregnancy) Illicit drug use during pregnancy (cocaine, heroin, methamphetamine) Maternal medical history of any chronic illness requiring medication (eg lupus, asthma, etc.) Abnormal maternal serum triple screen (AFP ≥2.5MoM, hCG >3.0 MoM)

Study Group IUGR:

Gestational age <20 weeks or ≥36 weeks Multiple pregnancy Any known or suspected fetal structural anomaly (including cardiac) Chromosomal abnormalities (on amniocentesis or CVS) Normal fetal growth with AC ≥10% Illicit drug use during pregnancy (cocaine, heroin, methamphetamine)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359034


Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Tracy Pressey, MD The University of British Columbia
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00359034     History of Changes
Other Study ID Numbers: H06-70016
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: January 2013

Keywords provided by University of British Columbia:
Doppler ultrasound
pulsewave velocity
intrauterine growth restriction
Fetal Pulsewave Velocity