<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/NCT04417283</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100000</org_study_id>
    <nct_id>NCT04417283</nct_id>
  </id_info>
  <brief_title>Project HOPE 1000: Health Outcomes Pregnancy Exposures</brief_title>
  <official_title>Project HOPE 1000: A Longitudinal Study of Mothers and Infants to Understand Health Outcomes Related to Pregnancy and Early-Life Exposures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      The purpose of this study is to collect biological samples from pregnant women and their&#xD;
      babies and to collect data on long-term health, school outcomes, and the use of state and&#xD;
      county services. The information learned from this study may help identify important factors&#xD;
      that may influence the health of mothers and babies, both short-and long-term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Humans pass through more biological milestones during gestation and the first two years of&#xD;
      life (known as the &quot;first 1000 days&quot;) than during any other period of development.&#xD;
      Consequently, both intrinsic biology/physiology and extrinsic factors such as environmental&#xD;
      exposures can have profound impacts on long-term health and disease outcomes. The purpose of&#xD;
      this project is to develop a cohort of mother-infant dyads that can provide a collection of&#xD;
      birth samples and be studied long-term - from pregnancy through early childhood - to help&#xD;
      identify early life factors that influence lifelong health and disease. The study will&#xD;
      include collection of specimens from pregnant women during each trimester of pregnancy, at&#xD;
      delivery, and within the first few months after giving birth, as well as collection of&#xD;
      specimens from the infants at birth and during their first two years of life. In addition to&#xD;
      specimens, health information will be collected from the participants' electronic health&#xD;
      records, and via questionnaires to assess health behaviors, social determinants, and&#xD;
      environmental exposures. Participants may also consent for yearly review of state&#xD;
      administrative data, including educational data, social services, and vital records. The&#xD;
      specimens and data collected in this study will allow for assessment of the impact of&#xD;
      different factors during pregnancy and early childhood on long-term health and well-being.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Pregnant</condition>
  <arm_group>
    <arm_group_label>Mother-infant dyads</arm_group_label>
    <description>Mother and/or infant participants will provide a series of biological specimens, including blood, urine, and microbiome samples. Additionally, each participant will wear a silicone wrist band each trimester to capture environmental exposures and will fill out study surveys related to diet, environmental exposures, and social factors.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Mother and/or infant participants will provide a series of biological specimens, including&#xD;
        blood, urine, and microbiome samples. Additionally, each participant will wear a silicone&#xD;
        wrist band each trimester to capture environmental exposures and will fill out study&#xD;
        surveys related to diet, environmental exposures, and social factors.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  The subject has provided a signed Informed consent prior to any study procedures.&#xD;
&#xD;
          -  Maternal age at consent of ≥ 18 years old&#xD;
&#xD;
          -  Ability to understand English or Spanish&#xD;
&#xD;
          -  Willingness to comply with and be available for all protocol procedures&#xD;
&#xD;
          -  Singleton gestation &lt; 24 weeks 0 days&#xD;
&#xD;
          -  Receiving prenatal care at a Duke-affiliated Obstetrics clinic with the intent of&#xD;
             delivering at Duke University Health System-affiliated hospital (including Duke&#xD;
             University Hospital and Duke Regional Hospital)&#xD;
&#xD;
          -  Plans to have their infant seen at a Duke-affiliated Pediatrics practice after birth&#xD;
&#xD;
          -  Plans to remain in the area for two years after delivery&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Non-viable pregnancy&#xD;
&#xD;
          -  Having any condition that, in the opinion of the site investigators, would place the&#xD;
             subject at unacceptable risk of injury or confound data interpretation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant participants can enroll in the first or second trimester of pregnancy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Gilner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer Gilner, MD</last_name>
    <phone>919-684-6327</phone>
    <email>jennifer.gilner@duke.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jillian Hurst, PhD</last_name>
    <phone>919-668-8776</phone>
    <email>jillian.hurst@duke.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Duke affiliated ObGyn clinics within Duke Health</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Gestation</keyword>
  <keyword>Placenta</keyword>
  <keyword>Exposure</keyword>
  <keyword>Environment</keyword>
  <keyword>Social Drivers of Health</keyword>
  <keyword>Infancy</keyword>
  <keyword>Biological specimens</keyword>
  <keyword>Electronic health records</keyword>
  <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/NCT04417283
org study id: Pro00100000
nct id: NCT04417283
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to collect biological samples from pregnant women and their
      babies and to collect data on long-term health, school outcomes, and the use of state and
      county services. The information learned from this study may help identify important factors
      that may influence the health of mothers and babies, both short-and long-term.
Humans pass through more biological milestones during gestation and the first two years of
      life (known as the "first 1000 days") than during any other period of development.
      Consequently, both intrinsic biology/physiology and extrinsic factors such as environmental
      exposures can have profound impacts on long-term health and disease outcomes. The purpose of
      this project is to develop a cohort of mother-infant dyads that can provide a collection of
      birth samples and be studied long-term - from pregnancy through early childhood - to help
      identify early life factors that influence lifelong health and disease. The study will
      include collection of specimens from pregnant women during each trimester of pregnancy, at
      delivery, and within the first few months after giving birth, as well as collection of
      specimens from the infants at birth and during their first two years of life. In addition to
      specimens, health information will be collected from the participants' electronic health
      records, and via questionnaires to assess health behaviors, social determinants, and
      environmental exposures. Participants may also consent for yearly review of state
      administrative data, including educational data, social services, and vital records. The
      specimens and data collected in this study will allow for assessment of the impact of
      different factors during pregnancy and early childhood on long-term health and well-being.
observational model: Cohort
time perspective: Prospective
measure: Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.
time frame: Up to 2 years
arm group label: Mother-infant dyads
description: Mother and/or infant participants will provide a series of biological specimens, including blood, urine, and microbiome samples. Additionally, each participant will wear a silicone wrist band each trimester to capture environmental exposures and will fill out study surveys related to diet, environmental exposures, and social factors.
Blood will be collected.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant participants can enroll in the first or second trimester of pregnancy
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Gilner, MD
role: Principal Investigator
affiliation: Duke University
last name: Jennifer Gilner, MD
phone: 919-684-6327
email: jennifer.gilner@duke.edu
last name: Jillian Hurst, PhD
phone: 919-668-8776
email: jillian.hurst@duke.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
sharing ipd: No