xml: <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/NCT06008561</url>
    </required_header>
    <id_info>
      <org_study_id>SH MBOIAP23</org_study_id>
      <secondary_id>5P20GM121341-05</secondary_id>
      <nct_id>NCT06008561</nct_id>
    </id_info>
    <brief_title>Midwest Birth Outcomes and Indigenous American Pregnancy</brief_title>
    <official_title>Midwest Birth Outcomes and American Indian Pregnancy: Associations With Historical Trauma and Psychosocial Stress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanford Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of General Medical Sciences (NIGMS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Sanford Health</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>
        Indigenous American pregnancies in the Midwest have disproportionally high rates of adverse&#xD;
        outcomes, however little research has been done on how historical trauma and stress may&#xD;
        impact these adverse outcomes. This project gathers data from pregnant Indigenous American&#xD;
        women on their experiences with historical trauma, stress, and birth outcomes, as well as&#xD;
        physiological data of how they respond to stress, in order to better understand the&#xD;
        associations between these factors and the biological mechanisms underlying them.&#xD;
        Understanding the mechanisms by which both historical and proximal stress &quot;get under the&#xD;
        skin&quot; and influence pregnancy health and perinatal outcomes, will afford new targets of&#xD;
        intervention to help reduce these IA health disparities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As the U.S. Healthy People 2030 Objectives include reducing rates of infant mortality from&#xD;
        5.4 to 5.0 live births per 1000, and preterm births from 10.1% to 9.6%, Indigenous American&#xD;
        (IA) women in the Midwest continue to experience disproportionately high rates of infant&#xD;
        mortality (8.8 per 1000 live births) and preterm birth (12.8%). Identified risk factors, such&#xD;
        as diet and access to healthcare, do not fully explain these persistent perinatal-health&#xD;
        disparities. Therefore, studies have begun to focus on culturally-relevant psychosocial&#xD;
        stressors such as historical trauma to try to understand he occurrence of adverse pregnancy&#xD;
        outcomes. Although a history of deculturation, devalued status, and reduced resources may&#xD;
        have long reaching impact, affecting new generations of IA women and their pregnancies, there&#xD;
        is a paucity of psychosocial research on IA perinatal health. It is imperative that&#xD;
        associations among IA historical trauma, proximal stressors, and physiological stress&#xD;
        responses during pregnancy are better understood to develop more effective interventions that&#xD;
        can improve IA perinatal health. Historical trauma may contribute to IA perinatal health&#xD;
        disparities by increasing the frequency and intensity of proximal stressors, including&#xD;
        experiences of racism and socioenvironmental stress in general, and by influencing&#xD;
        psychophysiological responses to stress. The investigators hypothesize that interactions&#xD;
        among historical trauma, proximal stress and physiological responses to acute stress will&#xD;
        predict length of gestation and birth weight for IA women. This project will: 1) determine if&#xD;
        historical trauma is associated with IA women's psychophysiological responses to acute stress&#xD;
        during pregnancy; 2) identify the degree to which historical trauma is associated with&#xD;
        increased risks of adverse pregnancy health and perinatal outcomes in IA pregnancies; and 3)&#xD;
        examine how historical trauma, psychophysiological responses to stress, and proximal maternal&#xD;
        stress may interact to predict adverse perinatal outcomes in IA pregnancies. To examine these&#xD;
        interactions, the investigators will recruit 100 pregnant IA women from Sanford Health&#xD;
        prenatal care providers to complete a lab visit between 23-28 weeks of pregnancy. While at&#xD;
        the lab they will 1) participate in a standardized laboratory psychophysiological challenge&#xD;
        task while blood pressure and heart rate are recorded and saliva is collected to assess&#xD;
        cortisol, immunoglobulin A, and c-reactive protein responses; 2) complete standardized&#xD;
        surveys on historical trauma, and proximal stress, mental and general health, and wellness&#xD;
        behaviors; and 3) provide consent to access medical records pertaining to prior and current&#xD;
        pregnancy health and perinatal outcomes. Understanding the mechanisms by which both&#xD;
        historical and proximal stress &quot;get under the skin&quot; and influence pregnancy health and&#xD;
        perinatal outcomes, will afford new targets of intervention to help reduce these IA health&#xD;
        disparities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>Gestational Age in weeks</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Pregnancy</condition>
    <eligibility>
      <study_pop>
        <textblock>
          We will recruit 100 pregnant women prior to their 29th week of gestation from Sanford&#xD;
          Health prenatal care providers in the Fargo, North Dakota, and Sioux Falls, South Dakota&#xD;
          greater metropolitan areas.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Less than 17 weeks&#xD;
  &#xD;
            -  Healthy single baby pregnancy&#xD;
  &#xD;
            -  Indigenous American&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Assistive reproductive technology (in-vitro fertilization)&#xD;
  &#xD;
            -  Have a history of cardiac and endocrine disease&#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>Anna M Strahm, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sanford Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Valentina Ayala Catalan</last_name>
      <phone>6053126406</phone>
      <email>strahmlab@sanfordhealth.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008561
  org study id: SH MBOIAP23
  secondary id: 5P20GM121341-05
  nct id: NCT06008561
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Indigenous American pregnancies in the Midwest have disproportionally high rates of adverse
        outcomes, however little research has been done on how historical trauma and stress may
        impact these adverse outcomes. This project gathers data from pregnant Indigenous American
        women on their experiences with historical trauma, stress, and birth outcomes, as well as
        physiological data of how they respond to stress, in order to better understand the
        associations between these factors and the biological mechanisms underlying them.
        Understanding the mechanisms by which both historical and proximal stress "get under the
        skin" and influence pregnancy health and perinatal outcomes, will afford new targets of
        intervention to help reduce these IA health disparities.
  As the U.S. Healthy People 2030 Objectives include reducing rates of infant mortality from
        5.4 to 5.0 live births per 1000, and preterm births from 10.1% to 9.6%, Indigenous American
        (IA) women in the Midwest continue to experience disproportionately high rates of infant
        mortality (8.8 per 1000 live births) and preterm birth (12.8%). Identified risk factors, such
        as diet and access to healthcare, do not fully explain these persistent perinatal-health
        disparities. Therefore, studies have begun to focus on culturally-relevant psychosocial
        stressors such as historical trauma to try to understand he occurrence of adverse pregnancy
        outcomes. Although a history of deculturation, devalued status, and reduced resources may
        have long reaching impact, affecting new generations of IA women and their pregnancies, there
        is a paucity of psychosocial research on IA perinatal health. It is imperative that
        associations among IA historical trauma, proximal stressors, and physiological stress
        responses during pregnancy are better understood to develop more effective interventions that
        can improve IA perinatal health. Historical trauma may contribute to IA perinatal health
        disparities by increasing the frequency and intensity of proximal stressors, including
        experiences of racism and socioenvironmental stress in general, and by influencing
        psychophysiological responses to stress. The investigators hypothesize that interactions
        among historical trauma, proximal stress and physiological responses to acute stress will
        predict length of gestation and birth weight for IA women. This project will: 1) determine if
        historical trauma is associated with IA women's psychophysiological responses to acute stress
        during pregnancy; 2) identify the degree to which historical trauma is associated with
        increased risks of adverse pregnancy health and perinatal outcomes in IA pregnancies; and 3)
        examine how historical trauma, psychophysiological responses to stress, and proximal maternal
        stress may interact to predict adverse perinatal outcomes in IA pregnancies. To examine these
        interactions, the investigators will recruit 100 pregnant IA women from Sanford Health
        prenatal care providers to complete a lab visit between 23-28 weeks of pregnancy. While at
        the lab they will 1) participate in a standardized laboratory psychophysiological challenge
        task while blood pressure and heart rate are recorded and saliva is collected to assess
        cortisol, immunoglobulin A, and c-reactive protein responses; 2) complete standardized
        surveys on historical trauma, and proximal stress, mental and general health, and wellness
        behaviors; and 3) provide consent to access medical records pertaining to prior and current
        pregnancy health and perinatal outcomes. Understanding the mechanisms by which both
        historical and proximal stress "get under the skin" and influence pregnancy health and
        perinatal outcomes, will afford new targets of intervention to help reduce these IA health
        disparities.
  observational model: Case-Only
  time perspective: Prospective
  measure: Gestational Age in weeks
  time frame: Through study completion, an average of 2 years
  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: Anna M Strahm, PhD
  role: Principal Investigator
  affiliation: Sanford Health
  last name: Valentina Ayala Catalan
  phone: 6053126406
  email: strahmlab@sanfordhealth.org
  responsible party type: Sponsor
  sharing ipd: No