<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/NCT03243513</url>
  </required_header>
  <id_info>
    <org_study_id>17-276</org_study_id>
    <nct_id>NCT03243513</nct_id>
  </id_info>
  <brief_title>Abo Follow-up Study</brief_title>
  <official_title>Abortion Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</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>
      The aim of the project is to identify an efficient and effective policy or procedure for&#xD;
      identifying complications from surgical abortions through follow-up phone calls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the project is to identify an efficient and effective policy or procedure for&#xD;
      identifying complications from surgical abortions through follow-up phone calls. Key&#xD;
      questions include, what is our complication-detection rate from these phone calls? How many&#xD;
      patients are contacted? How many attempts are made and how much effort is expended by staff&#xD;
      in routine follow-up practices? Additionally, the research would attempt to answer the&#xD;
      question, is there any way to predict problems or complications? This study will help to&#xD;
      determine if excessive resources and time are being expended on follow-up phone method to&#xD;
      detect complications.&#xD;
&#xD;
      This study will consist of a retrospective chart review identifying the outcome of follow-up&#xD;
      phone calls after an induced abortion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Follow-up Phone Calls</measure>
    <time_frame>2 years</time_frame>
    <description>Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices?</description>
  </primary_outcome>
  <enrollment type="Actual">1600</enrollment>
  <condition>Pregnancy Termination</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospective Chart Review</intervention_name>
    <description>There is no intervention in this research. This research project is a retrospective chart review.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        De-identified charts of women who have had an induced abortion and are contacted by a nurse&#xD;
        for a follow-up phone call.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reproductive-aged women&#xD;
&#xD;
          -  women who have had an induced abortion, and are contacted by a clinical nurse for a&#xD;
             follow-up phone call.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Lisa Hofler, MD, MBA, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Lisa Hofler</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan on sharing IPD at this time</ipd_description>
  </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/NCT03243513
org study id: 17-276
nct id: NCT03243513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the project is to identify an efficient and effective policy or procedure for
      identifying complications from surgical abortions through follow-up phone calls.
The aim of the project is to identify an efficient and effective policy or procedure for
      identifying complications from surgical abortions through follow-up phone calls. Key
      questions include, what is our complication-detection rate from these phone calls? How many
      patients are contacted? How many attempts are made and how much effort is expended by staff
      in routine follow-up practices? Additionally, the research would attempt to answer the
      question, is there any way to predict problems or complications? This study will help to
      determine if excessive resources and time are being expended on follow-up phone method to
      detect complications.

      This study will consist of a retrospective chart review identifying the outcome of follow-up
      phone calls after an induced abortion.
observational model: Other
time perspective: Retrospective
measure: Follow-up Phone Calls
time frame: 2 years
description: Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices?
intervention type: Other
intervention name: Retrospective Chart Review
description: There is no intervention in this research. This research project is a retrospective chart review.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
last name: Lisa Hofler, MD, MBA, MPH
role: Principal Investigator
affiliation: University of New Mexico
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Lisa Hofler
investigator title: Assistant Professor
sharing ipd: No
ipd description: We do not plan on sharing IPD at this time