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

This study has been withdrawn prior to enrollment.
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Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00359034
First received: July 28, 2006
Last updated: February 4, 2014
Last verified: January 2013
History of Changes
  Purpose

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
Healthy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Further study details as provided by University of British Columbia:
Enrollment: 0
Study Start Date: May 2006
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359034

Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Tracy Pressey, MD The University of British Columbia
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00359034     History of Changes
Other Study ID Numbers: H06-70016 
Study First Received: July 28, 2006
Last Updated: February 4, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 26, 2016