<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/NCT04481503</url>
  </required_header>
  <id_info>
    <org_study_id>D20144</org_study_id>
    <nct_id>NCT04481503</nct_id>
  </id_info>
  <brief_title>Transthoracic Echocardiography of Ventricular Function of Parturients in Labor</brief_title>
  <official_title>Transthoracic Echocardiography of Cardiac Function of Parturients in Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This echocardiography study will characterize heart structure and function during labor.&#xD;
      Imaging of the heart during the stress of labor could increase detection of subclinical&#xD;
      cardiovascular disease using advanced imaging techniques. Cardiac serum biomarkers and&#xD;
      complication rates will also be measured and compared between patients with and without&#xD;
      evidence of cardiovascular disease on echocardiography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 5, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients with an abnormal strain pattern as compared to parturients not in labor</measure>
    <time_frame>During echocardiogram procedure</time_frame>
    <description>Left ventricular strain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients with diastolic dysfunction as compared to parturients not in labor</measure>
    <time_frame>During echocardiogram procedure</time_frame>
    <description>Abnormal diastolic function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated right ventricular systolic pressure</measure>
    <time_frame>During echocardiogram procedure</time_frame>
    <description>Comparing estimated right ventricular systolic pressure between patients in active labor as compared to those who are not in active labor (mm Hg)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Left ventricular systolic function</measure>
    <time_frame>During echocardiogram procedure</time_frame>
    <description>Simpson's method of discs motion abnormalities and diastolic function</description>
  </other_outcome>
  <other_outcome>
    <measure>Left ventricular myocardial performance index</measure>
    <time_frame>During echocardiogram procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Total number of patients with the presence of regional wall motion abnormalities</measure>
    <time_frame>During echocardiogram procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Total number of patients with abnormal global right ventricular dysfunction</measure>
    <time_frame>During echocardiogram procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Right ventricular strain</measure>
    <time_frame>During echocardiogram procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Tricuspid annular plane systolic excursion</measure>
    <time_frame>During echocardiogram procedure</time_frame>
    <description>centimeters</description>
  </other_outcome>
  <other_outcome>
    <measure>Tissue doppler s'</measure>
    <time_frame>During echocardiogram procedure</time_frame>
    <description>cm/sec</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of maternal deaths within 0-42 days post-partum</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients with an identifiable Centers for Disease Control Severe Maternal Morbidity Identification complication post-partum</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
    <description>Acute myocardial infarction, aortic aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, ventricular fibrillation, conversion of cardiac rhythm, disseminated intravascular coagulation, eclampsia, heart failure, arrest during surgery or procedure, puerperal cerebrovascular disorders, pulmonary edema, aspiration, cardiopulmonary anesthesia complications, sepsis, shock, air or thrombotic embolism, blood product transfusion, hysterectomy, temporary tracheostomy, requiring ventilation</description>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients with a pulse oximetry reading &lt;90% after delivery</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients who required oxygen administration after delivery</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients who develop atrial fibrillation or premature atrial complexes</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients who develop a stroke</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
    <description>Stroke must be verified by imaging including either computed tomography or magnetic resonance imaging.</description>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients with an elevation in transaminase levels during labor or after delivery</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
    <description>Total hours from admission to discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients requiring intensive care unit admission within 42 days post delivery</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mortality within 42 days post delivery</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients with a post-partum diagnosis of post-partum hemorrhage</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The total number of patients who require additional uterotonic medications other than oxytocin after delivery</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
    <description>Medications include additional dosage of oxytocin above 3 units, methylergonovine, carboprost, tranexamic acid or misoprostol</description>
  </other_outcome>
  <other_outcome>
    <measure>The number of patients requiring a transfusion</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
    <description>Cell Saver, red blood cells, platelets, fresh frozen plasma, cryoprecipitate</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood loss</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
    <description>Estimated and quantitated blood loss as well as the difference between pre-delivery hemoglobin and post-delivery lowest hemoglobin during admission</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients requiring vasopressor after delivery to support blood pressure</measure>
    <time_frame>0 to 42 days post-partum</time_frame>
    <description>phenylephrine, ephedrine, norepinephrine, epinephrine, vasopressin, inhaled nitrous oxide, inhaled epoprostenol</description>
  </other_outcome>
  <other_outcome>
    <measure>Activin A level</measure>
    <time_frame>Less than 3 hours after echocardiogram procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Placental Growth Factor</measure>
    <time_frame>Less than 3 hours after echocardiogram procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Soluble endoglin</measure>
    <time_frame>Less than 3 hours after echocardiogram procedure</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Obstetric Labor Complications</condition>
  <condition>Cardiovascular Diseases in Pregnancy</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women between 18 and 35 years of age with singleton pregnancy in active labor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All healthy parturients 18 years of age or older with estimated gestation greater than&#xD;
             or equal to 37 weeks who are expected to deliver during their hospitalization.&#xD;
&#xD;
          -  During the echocardiographic exam, the patient must be in active labor with cervical&#xD;
             dilation between 6-10 cm and contractions that are spaced less than 5 minutes apart.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known functional or structural heart disease&#xD;
&#xD;
          -  Previously diagnosed pulmonary hypertension.&#xD;
&#xD;
          -  Comorbid disease other than diet controlled gestational diabetes, uncomplicated&#xD;
             obesity, mild asthma and euthyroid patients with a history of hypo or hyperthyroidism.&#xD;
&#xD;
          -  Parturients endorsing active use of non-prescription mind-altering drugs including&#xD;
             cocaine, methamphetamine, or ketamine.&#xD;
&#xD;
          -  Other non-inclusion criteria include inability to tolerate left lateral positioning&#xD;
             either symptomatically or by fetal heart rate monitoring, suspected hypo-or&#xD;
             hypercoagulable states that was not previously diagnosed, hemodynamic instability&#xD;
             requiring &gt;2 L crystalloid administration within 1 hour time frame after epidural&#xD;
             placement or vasopressor administration of &gt;15 mg ephedrine or &gt;300 mcg phenylephrine&#xD;
             administration within 1 hour after epidural placement.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Any pregnant patient, even if gender identity is male.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Leigh C Hickerson, MD</last_name>
    <phone>(603) 650-5000</phone>
    <email>leigh.c.hickerson@hitchcock.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leigh C Hickerson, MD</last_name>
      <phone>303-596-4059</phone>
      <email>leigh.c.hickerson@hitchcock.org</email>
    </contact>
    <investigator>
      <last_name>Leigh C Hickerson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Leigh C. Hickerson</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor Complications</mesh_term>
    <mesh_term>Cardiovascular Diseases</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/NCT04481503
org study id: D20144
nct id: NCT04481503
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This echocardiography study will characterize heart structure and function during labor.
      Imaging of the heart during the stress of labor could increase detection of subclinical
      cardiovascular disease using advanced imaging techniques. Cardiac serum biomarkers and
      complication rates will also be measured and compared between patients with and without
      evidence of cardiovascular disease on echocardiography.
observational model: Cohort
time perspective: Cross-Sectional
measure: The proportion of patients with an abnormal strain pattern as compared to parturients not in labor
time frame: During echocardiogram procedure
description: Left ventricular strain
measure: The proportion of patients with diastolic dysfunction as compared to parturients not in labor
time frame: During echocardiogram procedure
description: Abnormal diastolic function
measure: Estimated right ventricular systolic pressure
time frame: During echocardiogram procedure
description: Comparing estimated right ventricular systolic pressure between patients in active labor as compared to those who are not in active labor (mm Hg)
measure: Left ventricular systolic function
time frame: During echocardiogram procedure
description: Simpson's method of discs motion abnormalities and diastolic function
measure: Left ventricular myocardial performance index
time frame: During echocardiogram procedure
measure: Total number of patients with the presence of regional wall motion abnormalities
time frame: During echocardiogram procedure
measure: Total number of patients with abnormal global right ventricular dysfunction
time frame: During echocardiogram procedure
measure: Right ventricular strain
time frame: During echocardiogram procedure
measure: Tricuspid annular plane systolic excursion
time frame: During echocardiogram procedure
description: centimeters
measure: Tissue doppler s'
time frame: During echocardiogram procedure
description: cm/sec
measure: Total number of maternal deaths within 0-42 days post-partum
time frame: 0 to 42 days post-partum
measure: The number of patients with an identifiable Centers for Disease Control Severe Maternal Morbidity Identification complication post-partum
time frame: 0 to 42 days post-partum
description: Acute myocardial infarction, aortic aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, ventricular fibrillation, conversion of cardiac rhythm, disseminated intravascular coagulation, eclampsia, heart failure, arrest during surgery or procedure, puerperal cerebrovascular disorders, pulmonary edema, aspiration, cardiopulmonary anesthesia complications, sepsis, shock, air or thrombotic embolism, blood product transfusion, hysterectomy, temporary tracheostomy, requiring ventilation
measure: The number of patients with a pulse oximetry reading <90% after delivery
time frame: 0 to 42 days post-partum
measure: The number of patients who required oxygen administration after delivery
time frame: 0 to 42 days post-partum
measure: The number of patients who develop atrial fibrillation or premature atrial complexes
time frame: 0 to 42 days post-partum
measure: The number of patients who develop a stroke
time frame: 0 to 42 days post-partum
description: Stroke must be verified by imaging including either computed tomography or magnetic resonance imaging.
measure: The number of patients with an elevation in transaminase levels during labor or after delivery
time frame: 0 to 42 days post-partum
measure: Hospital length of stay
time frame: 0 to 42 days post-partum
description: Total hours from admission to discharge
measure: The number of patients requiring intensive care unit admission within 42 days post delivery
time frame: 0 to 42 days post-partum
measure: Mortality within 42 days post delivery
time frame: 0 to 42 days post-partum
measure: The number of patients with a post-partum diagnosis of post-partum hemorrhage
time frame: 0 to 42 days post-partum
measure: The total number of patients who require additional uterotonic medications other than oxytocin after delivery
time frame: 0 to 42 days post-partum
description: Medications include additional dosage of oxytocin above 3 units, methylergonovine, carboprost, tranexamic acid or misoprostol
measure: The number of patients requiring a transfusion
time frame: 0 to 42 days post-partum
description: Cell Saver, red blood cells, platelets, fresh frozen plasma, cryoprecipitate
measure: Blood loss
time frame: 0 to 42 days post-partum
description: Estimated and quantitated blood loss as well as the difference between pre-delivery hemoglobin and post-delivery lowest hemoglobin during admission
measure: Number of patients requiring vasopressor after delivery to support blood pressure
time frame: 0 to 42 days post-partum
description: phenylephrine, ephedrine, norepinephrine, epinephrine, vasopressin, inhaled nitrous oxide, inhaled epoprostenol
measure: Activin A level
time frame: Less than 3 hours after echocardiogram procedure
measure: Placental Growth Factor
time frame: Less than 3 hours after echocardiogram procedure
measure: Soluble endoglin
time frame: Less than 3 hours after echocardiogram procedure
Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Any pregnant patient, even if gender identity is male.
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leigh C Hickerson, MD
phone: (603) 650-5000
email: leigh.c.hickerson@hitchcock.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Leigh C. Hickerson
investigator title: Assistant Professor of Anesthesiology
mesh term: Obstetric Labor Complications
mesh term: Cardiovascular Diseases
sharing ipd: No