<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/NCT03808909</url>
  </required_header>
  <id_info>
    <org_study_id>18-280</org_study_id>
    <secondary_id>5U54MD004811-10</secondary_id>
    <nct_id>NCT03808909</nct_id>
  </id_info>
  <brief_title>Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders</brief_title>
  <acronym>Project_SuM</acronym>
  <official_title>Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </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>
      This study will determine the feasibility of offering expanded continuous labor support by&#xD;
      trauma- and addiction-trained medical paraprofessionals (i.e. doulas) at no cost to pregnant&#xD;
      women receiving care for substance use disorders (SUD). The long-term goal of this&#xD;
      transdisciplinary multilevel intervention is ultimately to reduce a major existing behavioral&#xD;
      health disparity in the state. This cross-campus multi-disciplinary collaboration, is in&#xD;
      partnership with Young Women United (a research and policy organization in NM) and doulas of&#xD;
      the UNM Birth Companion Program. Through this partnership, women receiving combined OB/SUD&#xD;
      treatment at the Milagro Program at UNMHSC will be offered expanded doula services.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Actual">July 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Remain in the Study</measure>
    <time_frame>2 week postpartum follow-up assessment</time_frame>
    <description>Number of participants who complete the 2 week follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alternative Birth Outcome</measure>
    <time_frame>birth</time_frame>
    <description>Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum Posttraumatic Stress Disorder Checklist</measure>
    <time_frame>2 week postpartum follow-up assessment</time_frame>
    <description>PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction</measure>
    <time_frame>2 week postpartum follow-up assessment</time_frame>
    <description>Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Days With Drinking or Substance Use</measure>
    <time_frame>2 week postpartum follow-up assessment</time_frame>
    <description>Using the timeline followback we will calculate average percentage of days of alcohol or other substance use for each group from pregnancy recognition to the 2 week follow-up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mother's Autonomy During Birth</measure>
    <time_frame>queries feelings during labor and birth but is administered at 2 week follow-up</time_frame>
    <description>Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42</description>
  </other_outcome>
  <other_outcome>
    <measure>Postpartum Depression</measure>
    <time_frame>2 week postpartum follow-up assessment</time_frame>
    <description>Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30</description>
  </other_outcome>
  <other_outcome>
    <measure>Breastfeeding Update</measure>
    <time_frame>2 week postpartum follow-up assessment</time_frame>
    <description>Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal Abstinence Syndrome</measure>
    <time_frame>neonatal</time_frame>
    <description>NAS diagnosis</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of NICU Stay</measure>
    <time_frame>from birth through study completion, an average of 3 months</time_frame>
    <description>Average length of time that the infant remains hospitalized in the NICU after the birth</description>
  </other_outcome>
  <other_outcome>
    <measure>Social Support - NIH Toolbox</measure>
    <time_frame>2 week postpartum follow-up assessment</time_frame>
    <description>Average score for social support on NIH toolbox Total of Emotional, Friend, and Instrumental Social support scales Higher scores indicated a better outcome Scale range = 24 - 120</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>Doula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be assigned a doula.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not be assigned a doula.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous Labor Support</intervention_name>
    <description>Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
    <arm_group_label>Doula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years old&#xD;
&#xD;
          -  able to participate in informed consent&#xD;
&#xD;
          -  able to read, write, and speak English&#xD;
&#xD;
          -  gestation of at least 26 weeks at baseline (necessary because of short duration of&#xD;
             study)&#xD;
&#xD;
          -  plan to give birth at UNM.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active psychosis&#xD;
&#xD;
          -  current incarceration&#xD;
&#xD;
          -  identified by medical staff as unable for medical reasons to currently participate in&#xD;
             the study&#xD;
&#xD;
          -  not interested in having doula support&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>November 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>July 21, 2022</results_first_submitted>
  <results_first_submitted_qc>November 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 30, 2022</results_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Pilar Sanjuan</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03808909/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Doula</title>
          <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Participants will not be assigned a doula.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Doula</title>
          <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Participants will not be assigned a doula.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Edinburgh Postpartum Depression Scale</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.11" spread="5.6667"/>
                    <measurement group_id="B2" value="18" spread="0"/>
                    <measurement group_id="B3" value="12.70" spread="5.65784"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PTSD Checklist - 5 (PCL-5)</title>
          <description>The PCL-5 is a 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5.&#xD;
A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items.&#xD;
Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples.&#xD;
See: https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.56" spread="23.591"/>
                    <measurement group_id="B2" value="23" spread="0"/>
                    <measurement group_id="B3" value="34.30" spread="22.593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent Drinking Days</title>
          <description>Percent drinking days from pregnancy recognition to baseline assessment collected with the Timeline Followback. See SOBELL, L.C., SOBELL, M.B., LEO, G.I. and CANCILLA, A. (1988), Reliability of a Timeline Method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. British Journal of Addiction, 83: 393-402. https://doi-org.libproxy.unm.edu/10.1111/j.1360-0443.1988.tb00485.x</description>
          <units>Percent of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent Substance Use Days</title>
          <description>Sum of all percent substance use days - can be more than 100% if multiple substances used during the same time frame (from pregnancy recognition to baseline assessment). SOBELL, L.C., SOBELL, M.B., LEO, G.I. and CANCILLA, A. (1988), Reliability of a Timeline Method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. British Journal of Addiction, 83: 393-402. https://doi-org.libproxy.unm.edu/10.1111/j.1360-0443.1988.tb00485.x</description>
          <units>Percent of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.75" spread="56.372"/>
                    <measurement group_id="B2" value="0" spread="0"/>
                    <measurement group_id="B3" value="47.47" spread="55.704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NIH Toolbox Emotional Support</title>
          <description>Measures perceived emotional support. Scale range = 5-40. Higher scores indicate more perceived support. See https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.00" spread="6.727"/>
                    <measurement group_id="B2" value="9" spread="0"/>
                    <measurement group_id="B3" value="30.60" spread="9.891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NIH Toolbox Friendship Support</title>
          <description>Measures perceived support from friends. Scale range = 5-40. Higher scores indicate more perceived support from friends. See: https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.89" spread="5.578"/>
                    <measurement group_id="B2" value="8" spread="0"/>
                    <measurement group_id="B3" value="16.90" spread="6.118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NIH Toolbox Instrumental Support</title>
          <description>Measures perceived instrumental support. Range = 5-40. Higher scores indicate more perceived support. See https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.22" spread="5.740"/>
                    <measurement group_id="B2" value="8" spread="0"/>
                    <measurement group_id="B3" value="27.10" spread="8.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Remain in the Study</title>
        <description>Number of participants who complete the 2 week follow-up</description>
        <time_frame>2 week postpartum follow-up assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Remain in the Study</title>
          <description>Number of participants who complete the 2 week follow-up</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alternative Birth Outcome</title>
        <description>Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes</description>
        <time_frame>birth</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Alternative Birth Outcome</title>
          <description>Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C-section</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preterm Birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fetal Demise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stillbirth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postpartum Posttraumatic Stress Disorder Checklist</title>
        <description>PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80</description>
        <time_frame>2 week postpartum follow-up assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Postpartum Posttraumatic Stress Disorder Checklist</title>
          <description>PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.38" spread="20.007"/>
                    <measurement group_id="O2" value="50" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction</title>
        <description>Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.</description>
        <time_frame>2 week postpartum follow-up assessment</time_frame>
        <population>Participants who were assigned a doula were included in this analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction</title>
          <description>Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.</description>
          <population>Participants who were assigned a doula were included in this analysis</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent of participants who found it very helpful emotionally to have a doula during labor/delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent of participants who found it very helpful physically to have a doula during labor/delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent of participants who found it very helpful socially to have a doula during labor/delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent of participants who would want a doula at another birth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent of participants who felt having a doula made pregnancy much easier</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent of participants who felt the doula understood their needs very well</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent of participants who were very satisfied with the doula experience</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Days With Drinking or Substance Use</title>
        <description>Using the timeline followback we will calculate average percentage of days of alcohol or other substance use for each group from pregnancy recognition to the 2 week follow-up.</description>
        <time_frame>2 week postpartum follow-up assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days With Drinking or Substance Use</title>
          <description>Using the timeline followback we will calculate average percentage of days of alcohol or other substance use for each group from pregnancy recognition to the 2 week follow-up.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.85" spread="44.509"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mother's Autonomy During Birth</title>
        <description>Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42</description>
        <time_frame>queries feelings during labor and birth but is administered at 2 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Mother's Autonomy During Birth</title>
          <description>Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8889" spread="11.66667"/>
                    <measurement group_id="O2" value="38" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Postpartum Depression</title>
        <description>Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30</description>
        <time_frame>2 week postpartum follow-up assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Postpartum Depression</title>
          <description>Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.56" spread="6.579"/>
                    <measurement group_id="O2" value="18" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Breastfeeding Update</title>
        <description>Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby</description>
        <time_frame>2 week postpartum follow-up assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Breastfeeding Update</title>
          <description>Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Breastfeeding intent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breastfeeding initiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breastfeeding at discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Exclusive breastfeeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Neonatal Abstinence Syndrome</title>
        <description>NAS diagnosis</description>
        <time_frame>neonatal</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Neonatal Abstinence Syndrome</title>
          <description>NAS diagnosis</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of NICU Stay</title>
        <description>Average length of time that the infant remains hospitalized in the NICU after the birth</description>
        <time_frame>from birth through study completion, an average of 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of NICU Stay</title>
          <description>Average length of time that the infant remains hospitalized in the NICU after the birth</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.56" spread="14.32"/>
                    <measurement group_id="O2" value="4" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Social Support - NIH Toolbox</title>
        <description>Average score for social support on NIH toolbox Total of Emotional, Friend, and Instrumental Social support scales Higher scores indicated a better outcome Scale range = 24 - 120</description>
        <time_frame>2 week postpartum follow-up assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Doula</title>
            <description>Participants will be assigned a doula.&#xD;
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will not be assigned a doula.</description>
          </group>
        </group_list>
        <measure>
          <title>Social Support - NIH Toolbox</title>
          <description>Average score for social support on NIH toolbox Total of Emotional, Friend, and Instrumental Social support scales Higher scores indicated a better outcome Scale range = 24 - 120</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.3333" spread="19.62142"/>
                    <measurement group_id="O2" value="25" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse event data was not collected as there was no data monitoring plan because this research was not considered more than minimal risk.</desc>
      <group_list>
        <group group_id="E1">
          <title>Doula</title>
          <description>Participants with a doula</description>
        </group>
        <group group_id="E2">
          <title>No Doula</title>
          <description>Participants without a doula</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This was a pilot feasibility study. We only collected data for 10 participants: 9 in the experimental condition - with a doula and 1 in the control condition. Thus, the data is primarily descriptive and there are not enough participants to conduct statistical comparisons between groups. This was because funding was only available for 12 mos and negotiations between community partners and the university delayed the start of data collection by more than 6 months.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Pilar Sanjuan</name_or_title>
      <organization>University of New Mexico, Health Sciences Center</organization>
      <phone>505/272-7055</phone>
      <email>psanjuan@salud.unm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03808909
org study id: 18-280
secondary id: 5U54MD004811-10
nct id: NCT03808909
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will determine the feasibility of offering expanded continuous labor support by
      trauma- and addiction-trained medical paraprofessionals (i.e. doulas) at no cost to pregnant
      women receiving care for substance use disorders (SUD). The long-term goal of this
      transdisciplinary multilevel intervention is ultimately to reduce a major existing behavioral
      health disparity in the state. This cross-campus multi-disciplinary collaboration, is in
      partnership with Young Women United (a research and policy organization in NM) and doulas of
      the UNM Birth Companion Program. Through this partnership, women receiving combined OB/SUD
      treatment at the Milagro Program at UNMHSC will be offered expanded doula services.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants Who Remain in the Study
time frame: 2 week postpartum follow-up assessment
description: Number of participants who complete the 2 week follow-up
measure: Alternative Birth Outcome
time frame: birth
description: Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes
measure: Postpartum Posttraumatic Stress Disorder Checklist
time frame: 2 week postpartum follow-up assessment
description: PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80
measure: Participant Satisfaction
time frame: 2 week postpartum follow-up assessment
description: Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.
measure: Percentage of Days With Drinking or Substance Use
time frame: 2 week postpartum follow-up assessment
description: Using the timeline followback we will calculate average percentage of days of alcohol or other substance use for each group from pregnancy recognition to the 2 week follow-up.
measure: Mother's Autonomy During Birth
time frame: queries feelings during labor and birth but is administered at 2 week follow-up
description: Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42
measure: Postpartum Depression
time frame: 2 week postpartum follow-up assessment
description: Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30
measure: Breastfeeding Update
time frame: 2 week postpartum follow-up assessment
description: Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby
measure: Neonatal Abstinence Syndrome
time frame: neonatal
description: NAS diagnosis
measure: Length of NICU Stay
time frame: from birth through study completion, an average of 3 months
description: Average length of time that the infant remains hospitalized in the NICU after the birth
measure: Social Support - NIH Toolbox
time frame: 2 week postpartum follow-up assessment
description: Average score for social support on NIH toolbox Total of Emotional, Friend, and Instrumental Social support scales Higher scores indicated a better outcome Scale range = 24 - 120
arm group label: Doula
arm group type: Experimental
description: Participants will be assigned a doula.
arm group label: Control
arm group type: No Intervention
description: Participants will not be assigned a doula.
intervention type: Other
intervention name: Continuous Labor Support
description: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
arm group label: Doula
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Pilar Sanjuan
investigator title: Research Assistant Professor
mesh term: Substance-Related Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This was a pilot feasibility study. We only collected data for 10 participants: 9 in the experimental condition - with a doula and 1 in the control condition. Thus, the data is primarily descriptive and there are not enough participants to conduct statistical comparisons between groups. This was because funding was only available for 12 mos and negotiations between community partners and the university delayed the start of data collection by more than 6 months.
point of contact: 