<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/NCT02213874</url>
  </required_header>
  <id_info>
    <org_study_id>Dempsey-Trust Pro 12660</org_study_id>
    <nct_id>NCT02213874</nct_id>
  </id_info>
  <brief_title>The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice</brief_title>
  <official_title>The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society of Family Planning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to understand the relationship between trust in the health&#xD;
      care system and choice of contraception during the postpartum period among pregnant women&#xD;
      receiving prenatal care.&#xD;
&#xD;
      Research subjects will complete a questionnaire at enrollment and between delivery and within&#xD;
      5 days of hospital discharge.&#xD;
&#xD;
      A chart review will also be completed to gather use of a birth control method at the six week&#xD;
      postpartum visit as well as pertinent medical diagnoses and recorded data such as height,&#xD;
      weight, body mass index, and contraceptive plan as documented in the postpartum medical&#xD;
      chart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of the proposed research are three-fold:&#xD;
&#xD;
        1. To identify whether trust in the health care system is associated with choice of the&#xD;
           highest efficacy contraception (intrauterine contraception, implantable contraception,&#xD;
           and sterilization) in the immediate postpartum period among pregnant women receiving&#xD;
           prenatal care.&#xD;
&#xD;
        2. To explore which patient-level factors (sociodemographic, reproductive history, future&#xD;
           pregnancy intentions) and provider-level factors (antenatal contraceptive counseling)&#xD;
           are associated with choice of the highest efficacy contraception in the immediate&#xD;
           postpartum period among pregnant women receiving prenatal care.&#xD;
&#xD;
        3. To determine whether trust in the health care system is altered during the receipt of&#xD;
           prenatal care or delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Choice of long acting contraception (IUD or implant) for postpartum contraception</measure>
    <time_frame>immediately postpartum</time_frame>
    <description>Using a questionnaire adminstered immediately postpartum, we will ascertain whether participants indicate plan to use either an IUD or implant for contraception. We will also measure use of IUD or implant through chart abstraction of their 6 week postpartum visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trust in the health care system</measure>
    <time_frame>immediately postpartum</time_frame>
    <description>We will also evaluate trust as an outcome and evaluate whether certain patient-level or antepartum care characteristics predict higher levels of trust. Trust is measured through a validated scale containing 17 questions measured using a likert scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Contraception Behavior</condition>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Questionnaire</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A questionnaire will be administered during the early stages of prenatal care &amp; again during the postpartum period. The initial questionnaire will assess trust in the health care system, locus of control, religiosity, health literacy &amp; collect information about demographics, contraceptive &amp; reproductive history, future pregnancy intentions, &amp; baseline knowledge about contraception. The postpartum questionnaire will repeat questions about future pregnancy &amp; contraception intentions, trust in the health care system, knowledge of contraception and collect new information about characteristics of antenatal contraceptive counseling received including whether a provider recommended a specific method of contraception, the amount of counseling received, &amp; the type of counseling received.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>A questionnaire will be administered during the early stages of prenatal care &amp; again during the postpartum period. The initial questionnaire will assess trust in the health care system, locus of control, religiosity, health literacy &amp; collect information about demographics, contraceptive &amp; reproductive history, future pregnancy intentions, &amp; baseline knowledge about contraception. The postpartum questionnaire will repeat questions about future pregnancy &amp; contraception intentions, trust in the health care system, knowledge of contraception and collect new information about characteristics of antenatal contraceptive counseling received including whether a provider recommended a specific method of contraception, the amount of counseling received, &amp; the type of counseling received.</description>
    <arm_group_label>Questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant Women receiving prenatal care at Medical University of South Carolina (MUSC)&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Greater than 20 weeks gestation&#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>Angela Angela Dempsey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MUSC Women's Health</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</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 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Angela Dempsey</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Pregnant Women</keyword>
  <keyword>Women's Health</keyword>
  <keyword>Contraception</keyword>
  <keyword>Trust in Health Care</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/NCT02213874
org study id: Dempsey-Trust Pro 12660
nct id: NCT02213874
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this research is to understand the relationship between trust in the health
      care system and choice of contraception during the postpartum period among pregnant women
      receiving prenatal care.

      Research subjects will complete a questionnaire at enrollment and between delivery and within
      5 days of hospital discharge.

      A chart review will also be completed to gather use of a birth control method at the six week
      postpartum visit as well as pertinent medical diagnoses and recorded data such as height,
      weight, body mass index, and contraceptive plan as documented in the postpartum medical
      chart.
The aims of the proposed research are three-fold:

        1. To identify whether trust in the health care system is associated with choice of the
           highest efficacy contraception (intrauterine contraception, implantable contraception,
           and sterilization) in the immediate postpartum period among pregnant women receiving
           prenatal care.

        2. To explore which patient-level factors (sociodemographic, reproductive history, future
           pregnancy intentions) and provider-level factors (antenatal contraceptive counseling)
           are associated with choice of the highest efficacy contraception in the immediate
           postpartum period among pregnant women receiving prenatal care.

        3. To determine whether trust in the health care system is altered during the receipt of
           prenatal care or delivery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Choice of long acting contraception (IUD or implant) for postpartum contraception
time frame: immediately postpartum
description: Using a questionnaire adminstered immediately postpartum, we will ascertain whether participants indicate plan to use either an IUD or implant for contraception. We will also measure use of IUD or implant through chart abstraction of their 6 week postpartum visit.
measure: Trust in the health care system
time frame: immediately postpartum
description: We will also evaluate trust as an outcome and evaluate whether certain patient-level or antepartum care characteristics predict higher levels of trust. Trust is measured through a validated scale containing 17 questions measured using a likert scale.
arm group label: Questionnaire
arm group type: Other
description: A questionnaire will be administered during the early stages of prenatal care & again during the postpartum period. The initial questionnaire will assess trust in the health care system, locus of control, religiosity, health literacy & collect information about demographics, contraceptive & reproductive history, future pregnancy intentions, & baseline knowledge about contraception. The postpartum questionnaire will repeat questions about future pregnancy & contraception intentions, trust in the health care system, knowledge of contraception and collect new information about characteristics of antenatal contraceptive counseling received including whether a provider recommended a specific method of contraception, the amount of counseling received, & the type of counseling received.
intervention type: Other
intervention name: Questionnaire
description: A questionnaire will be administered during the early stages of prenatal care & again during the postpartum period. The initial questionnaire will assess trust in the health care system, locus of control, religiosity, health literacy & collect information about demographics, contraceptive & reproductive history, future pregnancy intentions, & baseline knowledge about contraception. The postpartum questionnaire will repeat questions about future pregnancy & contraception intentions, trust in the health care system, knowledge of contraception and collect new information about characteristics of antenatal contraceptive counseling received including whether a provider recommended a specific method of contraception, the amount of counseling received, & the type of counseling received.
arm group label: Questionnaire
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Angela Angela Dempsey, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Angela Dempsey
investigator title: Associate Professor
sharing ipd: No