<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/NCT03783169</url>
  </required_header>
  <id_info>
    <org_study_id>18-027</org_study_id>
    <nct_id>NCT03783169</nct_id>
  </id_info>
  <brief_title>SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy</brief_title>
  <acronym>SASH</acronym>
  <official_title>SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      • Adjunctive use of easily-obtainable maternal sonographic vascular measurements assessing&#xD;
      volume status, cardiac output, and systemic vascular resistance by means of inferior vena&#xD;
      cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining&#xD;
      left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x&#xD;
      heart rate), stroke volume variation, &amp; radial artery resistance index) augments standard&#xD;
      vital sign assessment (pulse pressure and systolic / diastolic predominance) in clinical&#xD;
      decision-making potentially leading to more appropriate pharmacologic and clinical therapies&#xD;
      with faster resolution of severe hypertension among pregnant women and women in the&#xD;
      postpartum period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Minutes count when it comes to treating and preventing serious complications associated&#xD;
           with hypertensive emergencies in pregnancy. The rates of maternal morbidity and&#xD;
           mortality are on the rise within the United States whereas the rates are falling in the&#xD;
           rest of the developed world. Cardiovascular and neurologic injury associated with the&#xD;
           severe hypertension witnessed among women with preeclampsia/eclampsia represent two of&#xD;
           the leading causes of maternal mortality within the U.S. Optimizing the clinical&#xD;
           identification and response to these perinatal complications represents one means of&#xD;
           reducing overall maternal mortality.&#xD;
&#xD;
        -  Point-of-care use of ultrasound technology to augment clinical diagnosis and management&#xD;
           is gaining traction throughout nearly all fields of medicine. Obstetricians utilize this&#xD;
           technology frequently to assess the fetus and maternal-fetal interface, and our ability&#xD;
           to expand its use to assess a deeper understanding of maternal physiology is&#xD;
           underutilized. Exploration into the ability to apply clinically-proven point-of-care&#xD;
           sonographic techniques to augment maternal care and reduce maternal mortality is&#xD;
           warranted.&#xD;
&#xD;
        -  The purpose of this study is to gain a deeper understanding of maternal physiologic&#xD;
           changes using easily-obtainable sonographic vascular measurements in the setting of&#xD;
           hypertensive emergencies and to assess the utility of these adjunctive maternal&#xD;
           sonographic measurements in augmenting clinical decision-making.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>At Enrollment into the Study</time_frame>
    <description>Systolic Blood Pressure at Enrollment into the Study</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hypertension in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Symptomatic patients</arm_group_label>
    <description>All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure &gt; 160 mmHg or sustained diastolic blood pressure &gt; 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart). All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic patients</arm_group_label>
    <description>All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost. All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiovascular Sonographic Assessment</intervention_name>
    <description>Maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, &amp; radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance)</description>
    <arm_group_label>Asymptomatic patients</arm_group_label>
    <arm_group_label>Symptomatic patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Group 1: All pregnant women (under the care of the Maternal-Fetal Medicine physicians&#xD;
             or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive&#xD;
             emergency (sustained systolic blood pressure &gt; 160 mmHg or sustained diastolic blood&#xD;
             pressure &gt; 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart).&#xD;
             All participants must be over the age of 18 and capable of consenting to the study&#xD;
             (conscious, with capacity for medical decision making for themselves).&#xD;
&#xD;
          -  Group 2: All asymptomatic pregnant women who are undergoing routine obstetric&#xD;
             ultrasound evaluations at any gestational age who elect to undergo cardiovascular&#xD;
             sonographic assessment for research purposes at no cost. All participants must be over&#xD;
             the age of 18 and capable of consenting to the study (conscious, with capacity for&#xD;
             medical decision making for themselves).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For symptomatic women, those presenting to triage, admitted to Labor &amp; Delivery or any&#xD;
             of the above units who are at risk for developing a hypertensive emergency will be&#xD;
             identified by the OBGYN resident staff or attending physicians as &quot;at risk&quot; for&#xD;
             hypertensive emergency as based on current chronic hypertension, gestational&#xD;
             hypertension, or preeclampsia). Women presenting with or developing new onset&#xD;
             hypertensive emergency can be offered recruitment as well given that the performance&#xD;
             of these sonographic measures will not interfere with initiating antihypertensive&#xD;
             therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Non-pregnant&#xD;
&#xD;
          -  Without the capacity to provide informed written consent&#xD;
&#xD;
          -  Non-English speaking without the ability to obtain a hospital interpreter&#xD;
&#xD;
          -  Known atrial-ventricular heart block&#xD;
&#xD;
          -  History of heart failure&#xD;
&#xD;
          -  Moderate-to-Severe bronchial asthma&#xD;
&#xD;
          -  Allergy to the medications used as part of regular care treatment of the patient&#xD;
             population&#xD;
&#xD;
          -  Lack of intravenous IV access&#xD;
&#xD;
          -  Concurrent use of antihypertensive medications&#xD;
&#xD;
          -  Congenital heart disease in the mother&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Schnettler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ganga Devaiah, MS</last_name>
    <phone>513-862-2341</phone>
    <email>ganga_devaiah@trihealth.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amy Knapp-Jones, MSN, RN</last_name>
    <phone>513-865-1148</phone>
    <email>amy_knapp-jones@trihealth.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>TriHealth - Good Samaritan and Bethesda North Hospitals</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ganga Devaiah, MS</last_name>
      <phone>513-862-2341</phone>
      <email>ganga_devaiah@trihealth.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03783169
org study id: 18-027
nct id: NCT03783169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
• Adjunctive use of easily-obtainable maternal sonographic vascular measurements assessing
      volume status, cardiac output, and systemic vascular resistance by means of inferior vena
      cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining
      left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x
      heart rate), stroke volume variation, & radial artery resistance index) augments standard
      vital sign assessment (pulse pressure and systolic / diastolic predominance) in clinical
      decision-making potentially leading to more appropriate pharmacologic and clinical therapies
      with faster resolution of severe hypertension among pregnant women and women in the
      postpartum period.
-  Minutes count when it comes to treating and preventing serious complications associated
           with hypertensive emergencies in pregnancy. The rates of maternal morbidity and
           mortality are on the rise within the United States whereas the rates are falling in the
           rest of the developed world. Cardiovascular and neurologic injury associated with the
           severe hypertension witnessed among women with preeclampsia/eclampsia represent two of
           the leading causes of maternal mortality within the U.S. Optimizing the clinical
           identification and response to these perinatal complications represents one means of
           reducing overall maternal mortality.

        -  Point-of-care use of ultrasound technology to augment clinical diagnosis and management
           is gaining traction throughout nearly all fields of medicine. Obstetricians utilize this
           technology frequently to assess the fetus and maternal-fetal interface, and our ability
           to expand its use to assess a deeper understanding of maternal physiology is
           underutilized. Exploration into the ability to apply clinically-proven point-of-care
           sonographic techniques to augment maternal care and reduce maternal mortality is
           warranted.

        -  The purpose of this study is to gain a deeper understanding of maternal physiologic
           changes using easily-obtainable sonographic vascular measurements in the setting of
           hypertensive emergencies and to assess the utility of these adjunctive maternal
           sonographic measurements in augmenting clinical decision-making.
observational model: Case-Control
time perspective: Prospective
measure: Systolic Blood Pressure
time frame: At Enrollment into the Study
description: Systolic Blood Pressure at Enrollment into the Study
arm group label: Symptomatic patients
description: All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure > 160 mmHg or sustained diastolic blood pressure > 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart). All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
arm group label: Asymptomatic patients
description: All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost. All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
intervention type: Other
intervention name: Cardiovascular Sonographic Assessment
description: Maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance)
arm group label: Asymptomatic patients
arm group label: Symptomatic patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: William Schnettler, MD
role: Principal Investigator
affiliation: TriHealth Inc.
last name: Ganga Devaiah, MS
phone: 513-862-2341
email: ganga_devaiah@trihealth.com
last name: Amy Knapp-Jones, MSN, RN
phone: 513-865-1148
email: amy_knapp-jones@trihealth.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension
sharing ipd: No