- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01698957
Maternal Uterine Artery Doppler Study
November 21, 2016 updated by: Obstetrix Medical Group
A Simple Technique to Modify Maternal Uterine Artery Perfusion.
The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.
Study Overview
Status
Completed
Conditions
Detailed Description
In the setting of uteroplacental insufficiency, there is little that can be done to increase blood flow through the uterus and placenta.
Historically, women with growth restricted fetuses or oligohydramnios have been placed on bed rest.
Unfortunately, this treatment modality has met with only limited success.
Cardiologists have long recognized the simple act of making a fist or otherwise occluding blood flow through a limb dramatically increases a person's peripheral vascular resistance.
If maternal peripheral resistance can be increased, perhaps the increased differential between the maternal peripheral vascular resistance and that of the uteroplacental unit will increase flow through the uterus and placenta.
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Glendale, Arizona, United States, 85308
- Phoenix Perinatal Associates
-
Phoenix, Arizona, United States, 85014
- Phoenix Perinatal Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women greater than or equal to 18 weeks gestation and 18 years old eligible for an ultrasound without fetal or uterine anomalies
Description
Inclusion Criteria:
- Pregnant women greater than or equal to 18 years old
- Able to speak and read English
- Have a singleton pregnancy greater than or equal to 18 weeks gestation
Exclusion Criteria:
- Multiple gestation
- Less than 18 weeks gestation
- Uterine anomalies
- Fetal anomalies
- Preeclampsia
- Hypertension
- Inability to have BP cuff on left arm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
UA Doppler Velocimetry
Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
|
bilateral Uterine artery Doppler readings pre- and during blood pressure measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uterine Artery Doppler
Time Frame: at time of routine ultrasound
|
The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.
|
at time of routine ultrasound
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas H Strong, MD, Obstetrix Medical Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
October 1, 2012
First Submitted That Met QC Criteria
October 1, 2012
First Posted (Estimate)
October 3, 2012
Study Record Updates
Last Update Posted (Estimate)
November 22, 2016
Last Update Submitted That Met QC Criteria
November 21, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- UA Doppler 2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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