<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/NCT04450251</url>
  </required_header>
  <id_info>
    <org_study_id>OWLET-01</org_study_id>
    <nct_id>NCT04450251</nct_id>
  </id_info>
  <brief_title>Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection</brief_title>
  <official_title>Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Owlet Baby Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Owlet Baby Care, 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>
      Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn&#xD;
      around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this&#xD;
      proposed test is to collect overnight &quot;at-home&quot; fetal ECG recordings on women during the&#xD;
      second half of pregnancy using the pregnancy monitor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 29, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>16 Weeks</target_duration>
  <primary_outcome>
    <measure>The objective of this study is to collect observational fetal ECG readings with a novel wearable device</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pregnant women, at least 24 weeks gestation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data Collection</intervention_name>
    <description>Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.</description>
    <arm_group_label>Pregnant women, at least 24 weeks gestation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 500 pregnant women 24 weeks gestation and up in the second or third trimester&#xD;
        of pregnancy will be screened into the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman, 18 years of age and up.&#xD;
&#xD;
          -  Singleton or twin pregnancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported substance abuse problems.&#xD;
&#xD;
          -  Anyone unable or unwilling to give informed consent.&#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>Kenneth Ward, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Owlet Baby Care, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kenneth Ward, MD</last_name>
    <phone>801-647-1209</phone>
    <email>kward@owletcare.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Madison Kenley, BS, CCRC</last_name>
    <phone>801-552-8383</phone>
    <email>mkenley@owletcare.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Owlet Baby Care, Inc.</name>
      <address>
        <city>Lehi</city>
        <state>Utah</state>
        <zip>84043</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Madison Kenley, BS, CCRC</last_name>
      <phone>801-552-8383</phone>
      <email>mkenley@owletcare.com</email>
    </contact>
    <investigator>
      <last_name>Kenneth Ward, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy Tracker</keyword>
  <keyword>Owlet Band</keyword>
  <keyword>Owlet</keyword>
  <keyword>Wearable Tech</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/NCT04450251
org study id: OWLET-01
nct id: NCT04450251
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn
      around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this
      proposed test is to collect overnight "at-home" fetal ECG recordings on women during the
      second half of pregnancy using the pregnancy monitor.
observational model: Other
time perspective: Prospective
measure: The objective of this study is to collect observational fetal ECG readings with a novel wearable device
time frame: Up to 16 weeks
arm group label: Pregnant women, at least 24 weeks gestation
intervention type: Other
intervention name: Data Collection
description: Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.
arm group label: Pregnant women, at least 24 weeks gestation
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: Kenneth Ward, MD
role: Principal Investigator
affiliation: Owlet Baby Care, Inc.
last name: Kenneth Ward, MD
phone: 801-647-1209
email: kward@owletcare.com
last name: Madison Kenley, BS, CCRC
phone: 801-552-8383
email: mkenley@owletcare.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No