<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698957</url>
  </required_header>
  <id_info>
    <org_study_id>UA Doppler 2012</org_study_id>
    <nct_id>NCT01698957</nct_id>
  </id_info>
  <brief_title>Maternal Uterine Artery Doppler Study</brief_title>
  <official_title>A Simple Technique to Modify Maternal Uterine Artery Perfusion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Obstetrix Medical Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pediatrix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to detect if adding resistance to maternal blood flow from the&#xD;
      arm will help increase the blood flow through the uterine arteries to the placenta and the&#xD;
      baby.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the setting of uteroplacental insufficiency, there is little that can be done to increase&#xD;
      blood flow through the uterus and placenta. Historically, women with growth restricted&#xD;
      fetuses or oligohydramnios have been placed on bed rest. Unfortunately, this treatment&#xD;
      modality has met with only limited success. Cardiologists have long recognized the simple act&#xD;
      of making a fist or otherwise occluding blood flow through a limb dramatically increases a&#xD;
      person's peripheral vascular resistance. If maternal peripheral resistance can be increased,&#xD;
      perhaps the increased differential between the maternal peripheral vascular resistance and&#xD;
      that of the uteroplacental unit will increase flow through the uterus and placenta.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Uterine Artery Doppler</measure>
    <time_frame>at time of routine ultrasound</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Maternal-Fetal Exchange</condition>
  <arm_group>
    <arm_group_label>UA Doppler Velocimetry</arm_group_label>
    <description>Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.</intervention_name>
    <description>bilateral Uterine artery Doppler readings pre- and during blood pressure measurement</description>
    <arm_group_label>UA Doppler Velocimetry</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women greater than or equal to 18 weeks gestation and 18 years old eligible for an&#xD;
        ultrasound without fetal or uterine anomalies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women greater than or equal to 18 years old&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  Have a singleton pregnancy greater than or equal to 18 weeks gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Less than 18 weeks gestation&#xD;
&#xD;
          -  Uterine anomalies&#xD;
&#xD;
          -  Fetal anomalies&#xD;
&#xD;
          -  Preeclampsia&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Inability to have BP cuff on left arm&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas H Strong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Obstetrix Medical Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Perinatal Associates</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Perinatal Associates</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnant women</keyword>
  <keyword>Uterine Artery Doppler Velocimetry</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698957
org study id: UA Doppler 2012
nct id: NCT01698957
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Uterine Artery Doppler
time frame: at time of routine ultrasound
description: 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.
arm group label: UA Doppler Velocimetry
description: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
intervention type: Other
intervention name: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
description: bilateral Uterine artery Doppler readings pre- and during blood pressure measurement
arm group label: UA Doppler Velocimetry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas H Strong, MD
role: Principal Investigator
affiliation: Obstetrix Medical Group
facility: 
facility: 
country: United States
responsible party type: Sponsor