HealthyNCT00359034
Fetal Aortic Pulsewave Velocity: A Novel Doppler Ultrasound Method of Measuring the Biophysical Properties of the Fetal Aorta
An observational study of Healthy, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2006to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Singleton pregnancy between 20-36 weeks GA presenting at British Columbia Women's Hospital.
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
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.
Read the detailed description
Prospective subjects will be recruited through:
- Recruitment posters placed in the DAP department at BCWH. A contact number for the research nurse will be included on the recruitment poster for interested subjects to contact.
- The antepartum inpatient unit at BCWH. Prospective subjects will be identified by the charge nurse as those patients satisfying the inclusion and exclusion criteria. Potential subjects will be asked by the charge nurse if they are interested in meeting a study investigator or research nurse for more information.
- The same subject can participate twice in the study, once before 28 weeks and once after 28 weeks, as long as 3 weeks have passed between the study periods. All subjects participating before 28 weeks will be asked during the consent process if they are interested in participating a second time. Subjects in agreement will be contacted by the study nurse by phone to arrange a second appointment.
Study Procedure
Subject Involvement Measuring the PWV requires placing 3 electrocardiography (ECG) leads over the maternal abdomen in various positions to detect the fetal ECG signal. We have established that the fetal ECG signal can be detected as a small deflection in the maternal ECG tracing. The fetal ECG signal will allow us to correlate the blood flow wave form in the descending aorta to the fetal cardiac cycle. The onset of the blood flow waveform will be assessed at two points (A and B) along the descending aorta using standard pulsed Doppler ultrasound techniques. Point A will be the aortic isthmus and Point B will be at or beyond the level of the renal arteries. Measurements will be obtained in the following sequence: 1) time required for waveform to travel from Point A to Point B; 2) distance (mm) between Point A and Point B; 3) fetal heart rate using M-mode. The time it takes for the waveform to travel the measured distance between points A and B, will allow us to calculate the PWV in that portion of the fetal aorta. This sequence of measurements will be repeated three times in each fetus.
Subject Protocol
- Subjects will be asked to drink 500 cc of water prior to arrival to appointment to ensure adequate hydration (which can affect amniotic fluid volume).
- Subjects will be asked to void prior to entering study room.
- Subjects will placed in the left lateral decubitus supine position
- Subjects will rest for 15 minutes prior to the start of the ultrasound examination. At this time, consents will be reviewed again, and the demographic information recorded.
- ECG electrodes will applied to the maternal abdomen
- Fetal biometry, AFI and umbilical artery Dopplers will be performed (if not done within past 48 hours).
- PWV will be determined at three times, within 10 minutes.
The demographic and pregnancy information collected will include:
- maternal age
- gestational age at the time of the study
- obstetrical history (gravida, term, preterm, abortus, living)
- maternal smoking history
- amniotic fluid volume
- estimated fetal weight and/or growth parameter percentiles
The following information will be collected and recorded during the study ultrasound:
- time required to obtain the PWV measurement
- the calculated PWV
- maternal blood pressure and pulse
- fetal presentation
- fetal heart rate
- presence or absence of fetal activity or breathing during the study
- AFI and UA Doppler waveforms.
- Conditions
- Healthy
- Keywords
- Doppler ultrasound, pulsewave velocity, intrauterine growth restriction, Fetal Pulsewave Velocity
- Medical subject headings
- Fetal Growth Retardation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Why it stopped: Could not resolve technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy Pressey, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359034
- Sponsor's protocol ID
- H06-70016
- Status last verified
- Jan 2013
- First submitted
- 28 Jul 2006
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Aortic Pulsewave Velocity: A Novel Doppler Ultrasound Method of Measuring the Biophysical Properties of the Fetal Aorta
- ClinicalTrials.gov ID
- NCT00359034
- Acronym / sponsor ID
- H06-70016
- Conditions
- Healthy
- Keywords
- Doppler ultrasound, pulsewave velocity, intrauterine growth restriction, Fetal Pulsewave Velocity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Could not resolve technical difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective subjects will be recruited through:
- Recruitment posters placed in the DAP department at BCWH. A contact number for the research nurse will be included on the recruitment poster for interested subjects to contact.
- The antepartum inpatient unit at BCWH. Prospective subjects will be identified by the charge nurse as those patients satisfying the inclusion and exclusion criteria. Potential subjects will be asked by the charge nurse if they are interested in meeting a study investigator or research nurse for more information.
- The same subject can participate twice in the study, once before 28 weeks and once after 28 weeks, as long as 3 weeks have passed between the study periods. All subjects participating before 28 weeks will be asked during the consent process if they are interested in participating a second time. Subjects in agreement will be contacted by the study nurse by phone to arrange a second appointment.
Study Procedure
Subject Involvement Measuring the PWV requires placing 3 electrocardiography (ECG) leads over the maternal abdomen in various positions to detect the fetal ECG signal. We have established that the fetal ECG signal can be detected as a small deflection in the maternal ECG tracing. The fetal ECG signal will allow us to correlate the blood flow wave form in the descending aorta to the fetal cardiac cycle. The onset of the blood flow waveform will be assessed at two points (A and B) along the descending aorta using standard pulsed Doppler ultrasound techniques. Point A will be the aortic isthmus and Point B will be at or beyond the level of the renal arteries. Measurements will be obtained in the following sequence: 1) time required for waveform to travel from Point A to Point B; 2) distance (mm) between Point A and Point B; 3) fetal heart rate using M-mode. The time it takes for the waveform to travel the measured distance between points A and B, will allow us to calculate the PWV in that portion of the fetal aorta. This sequence of measurements will be repeated three times in each fetus.
Subject Protocol
- Subjects will be asked to drink 500 cc of water prior to arrival to appointment to ensure adequate hydration (which can affect amniotic fluid volume).
- Subjects will be asked to void prior to entering study room.
- Subjects will placed in the left lateral decubitus supine position
- Subjects will rest for 15 minutes prior to the start of the ultrasound examination. At this time, consents will be reviewed again, and the demographic information recorded.
- ECG electrodes will applied to the maternal abdomen
- Fetal biometry, AFI and umbilical artery Dopplers will be performed (if not done within past 48 hours).
- PWV will be determined at three times, within 10 minutes.
The demographic and pregnancy information collected will include:
- maternal age
- gestational age at the time of the study
- obstetrical history (gravida, term, preterm, abortus, living)
- maternal smoking history
- amniotic fluid volume
- estimated fetal weight and/or growth parameter percentiles
The following information will be collected and recorded during the study ultrasound:
- time required to obtain the PWV measurement
- the calculated PWV
- maternal blood pressure and pulse
- fetal presentation
- fetal heart rate
- presence or absence of fetal activity or breathing during the study
- AFI and UA Doppler waveforms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Singleton pregnancy between 20-36 weeks GA presenting at British Columbia Women's Hospital.
Key inclusion criteria (4 listed)
- Singleton pregnancy between 20 weeks 0 days and 36 weeks 0 days Normal obstetrical ultrasound in DAP at BCWH between 20-36 weeks GA
- 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)
Key exclusion criteria (4 listed)
- 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)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Pressey, MD principal investigator
The University of British Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.