<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/NCT03022526</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16060602</org_study_id>
    <nct_id>NCT03022526</nct_id>
  </id_info>
  <brief_title>CSE v. Epidural for Postpartum Depression</brief_title>
  <acronym>COPE</acronym>
  <official_title>Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grace Lim, MD, MS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot prospective randomized control trial is to compare the initiation&#xD;
      of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on&#xD;
      risk for postpartum depression symptoms. Investigators will randomize women to the receipt of&#xD;
      CSE or E during labor, after measuring baseline psychological, psychosocial, and&#xD;
      psychophysical factors related to pain and depression. The immediate research goals are to&#xD;
      understand whether the association between labor pain and PPD is modifiable through the use&#xD;
      of tailored anesthetic techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Edinburgh Postnatal Depression Score (EPDS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score on Average (BPI - Short Form)</measure>
    <time_frame>2 days postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score on Average (BPI - Short Form)</measure>
    <time_frame>6 weeks postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score on Average (BPI - Short Form)</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress (PSS)</measure>
    <time_frame>2 days postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)</measure>
    <time_frame>2 Days Postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)</measure>
    <time_frame>6 weeks postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-Infant Attachment (MPAS)</measure>
    <time_frame>6 weeks postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-Infant Attachment (MPAS)</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Development (ASQ-3) Personal Social Score</measure>
    <time_frame>6 weeks postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Development (ASQ-3) Personal Social Score</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Self-efficacy (PMP-SE)</measure>
    <time_frame>6 weeks postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Self-Efficacy (PMP-SE)</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Score (EPDS)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Depression, Postpartum</condition>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>CSE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidural</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CSE</intervention_name>
    <arm_group_label>CSE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural</intervention_name>
    <arm_group_label>Epidural</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine / fentaNYL</intervention_name>
    <arm_group_label>CSE</arm_group_label>
    <arm_group_label>Epidural</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous (no prior childbirth)&#xD;
&#xD;
          -  Singleton gestation&#xD;
&#xD;
          -  Third trimester&#xD;
&#xD;
          -  Healthy pregnancy&#xD;
&#xD;
          -  English proficiency (surveys validated in English)&#xD;
&#xD;
          -  Planned vaginal delivery&#xD;
&#xD;
          -  Planning to use labor epidural analgesia&#xD;
&#xD;
          -  Term delivery (&gt;/= 37.0 weeks)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe maternal disease&#xD;
&#xD;
          -  Severe fetal disease&#xD;
&#xD;
          -  Delivery not at term (delivery prior to 37.0 weeks)&#xD;
&#xD;
          -  Contraindications to neuraxial anesthesia known at the time of enrollment&#xD;
&#xD;
          -  Cesarean delivery WITHOUT labor&#xD;
&#xD;
          -  Planning to list infant for adoption&#xD;
&#xD;
          -  Did not receive epidural analgesia (either CSE or E) for labor&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Magee Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Prevalence of self-reported postpartum depressive symptoms--17 states, 2004-2005. MMWR Morb Mortal Wkly Rep. 2008 Apr 11;57(14):361-6.</citation>
    <PMID>18401329</PMID>
  </reference>
  <reference>
    <citation>Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.</citation>
    <PMID>23487258</PMID>
  </reference>
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    <citation>Logsdon MC, Wisner KL, Pinto-Foltz MD. The impact of postpartum depression on mothering. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):652-8. doi: 10.1111/j.1552-6909.2006.00087.x.</citation>
    <PMID>16958723</PMID>
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    <citation>Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.</citation>
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    <citation>Righetti-Veltema M, Conne-Perreard E, Bousquet A, Manzano J. Risk factors and predictive signs of postpartum depression. J Affect Disord. 1998 Jun;49(3):167-80. doi: 10.1016/s0165-0327(97)00110-9.</citation>
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    <PMID>24140480</PMID>
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    <citation>Chapman C. The Psychophysiology of Pain by C. Richard Chapman. In: Fishman S, Ballantyne J, Rathmell JP, editors. Bonica's Management of Pain. Fourth ed. Baltimore, MD: Lippincott Williams &amp; Wilkins; 2010. p. 375</citation>
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    <citation>Gross KH, Wells CS, Radigan-Garcia A, Dietz PM. Correlates of self-reports of being very depressed in the months after delivery: results from the Pregnancy Risk Assessment Monitoring System. Matern Child Health J. 2002 Dec;6(4):247-53. doi: 10.1023/a:1021110100339.</citation>
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    <citation>O'Hara M, Swain A. Rates and risk of postpartum depression-A meta-analysis. Int Rev Psychiatry. 1996;8:37-54</citation>
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    <citation>Schmidt RM, Wiemann CM, Rickert VI, Smith EO. Moderate to severe depressive symptoms among adolescent mothers followed four years postpartum. J Adolesc Health. 2006 Jun;38(6):712-8. doi: 10.1016/j.jadohealth.2005.05.023.</citation>
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    <citation>Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33.</citation>
    <PMID>20949886</PMID>
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    <citation>Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.</citation>
    <PMID>19318144</PMID>
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    <citation>Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.</citation>
    <PMID>15883651</PMID>
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    <citation>Davalos DB, Yadon CA, Tregellas HC. Untreated prenatal maternal depression and the potential risks to offspring: a review. Arch Womens Ment Health. 2012 Feb;15(1):1-14. doi: 10.1007/s00737-011-0251-1. Epub 2012 Jan 4.</citation>
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    <citation>Murray L, Arteche A, Fearon P, Halligan S, Goodyer I, Cooper P. Maternal postnatal depression and the development of depression in offspring up to 16 years of age. J Am Acad Child Adolesc Psychiatry. 2011 May;50(5):460-70. doi: 10.1016/j.jaac.2011.02.001. Epub 2011 Apr 5.</citation>
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    <citation>Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, O'Connor TG, Stein A. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA Psychiatry. 2013 Dec;70(12):1312-9. doi: 10.1001/jamapsychiatry.2013.2163.</citation>
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    <citation>Ross LE, McQueen K, Vigod S, Dennis CL. Risk for postpartum depression associated with assisted reproductive technologies and multiple births: a systematic review. Hum Reprod Update. 2011 Jan-Feb;17(1):96-106. doi: 10.1093/humupd/dmq025. Epub 2010 Jul 6.</citation>
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    <citation>Howard LM, Oram S, Galley H, Trevillion K, Feder G. Domestic violence and perinatal mental disorders: a systematic review and meta-analysis. PLoS Med. 2013;10(5):e1001452. doi: 10.1371/journal.pmed.1001452. Epub 2013 May 28.</citation>
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    <citation>Sanger C, Iles JE, Andrew CS, Ramchandani PG. Associations between postnatal maternal depression and psychological outcomes in adolescent offspring: a systematic review. Arch Womens Ment Health. 2015 Apr;18(2):147-162. doi: 10.1007/s00737-014-0463-2. Epub 2014 Oct 2.</citation>
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  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>July 24, 2020</results_first_submitted>
  <results_first_submitted_qc>July 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2020</results_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Grace Lim, MD, MS</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Pregnant</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Labor analgesia</keyword>
  <keyword>Epidural</keyword>
  <keyword>Combined spinal epidural</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Labor Pain</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03022526/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>We aimed to have 46 participants completing the trial, so enrolled until we hit that mark (greater than 46 enrolled due to loss to follow up).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Combined Spinal Epidural (CSE)</title>
          <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
        </group>
        <group group_id="P2">
          <title>Epidural</title>
          <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Combined Spinal Epidural (CSE)</title>
          <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
        </group>
        <group group_id="B2">
          <title>Epidural</title>
          <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</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="31"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.36" spread="4.64"/>
                    <measurement group_id="B2" value="27.56" spread="6.05"/>
                    <measurement group_id="B3" value="27.46" spread="5.37"/>
                  </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="31"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                  </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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="59"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_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="31"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Edinburgh Postnatal Depression Score (EPDS)</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.</description>
        <time_frame>6 weeks</time_frame>
        <population>Included all participants who completed electronically administered EPDS at the 6 week timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Edinburgh Postnatal Depression Score (EPDS)</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.</description>
          <population>Included all participants who completed electronically administered EPDS at the 6 week timepoint.</population>
          <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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.23" spread="3.93"/>
                    <measurement group_id="O2" value="4.71" spread="5.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7463</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score on Average (BPI - Short Form)</title>
        <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
        <time_frame>2 days postpartum</time_frame>
        <population>Included all participants who completed electronically administered BPI short form at at the postpartum day 2 timepoint and who reported current pain at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score on Average (BPI - Short Form)</title>
          <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
          <population>Included all participants who completed electronically administered BPI short form at at the postpartum day 2 timepoint and who reported current pain at the time of assessment.</population>
          <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="14"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.64" spread="2.13"/>
                    <measurement group_id="O2" value="4.19" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5764</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score on Average (BPI - Short Form)</title>
        <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
        <time_frame>6 weeks postpartum</time_frame>
        <population>Included all participants who completed electronically administered BPI short form at at the 6 week timepoint and who reported current pain at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score on Average (BPI - Short Form)</title>
          <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
          <population>Included all participants who completed electronically administered BPI short form at at the 6 week timepoint and who reported current pain at the time of assessment.</population>
          <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="5"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="2.35"/>
                    <measurement group_id="O2" value="4.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7169</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score on Average (BPI - Short Form)</title>
        <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
        <time_frame>3 months postpartum</time_frame>
        <population>Included all participants who completed electronically administered BPI short form at at the 3 month timepoint and who reported current pain at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score on Average (BPI - Short Form)</title>
          <description>Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered &quot;yes&quot; to question: &quot;Have you had pain other than everyday kinds of pain today?&quot;</description>
          <population>Included all participants who completed electronically administered BPI short form at at the 3 month timepoint and who reported current pain at the time of assessment.</population>
          <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="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="2.12"/>
                    <measurement group_id="O2" value="2.00" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4226</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Stress (PSS)</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.</description>
        <time_frame>2 days postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered PSS at the postpartum day 2 timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Stress (PSS)</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.</description>
          <population>This population includes all participants who completed the electronically administered PSS at the postpartum day 2 timepoint.</population>
          <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="25"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.08" spread="6.80"/>
                    <measurement group_id="O2" value="12.39" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6873</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)</title>
        <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
        <time_frame>2 Days Postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered breastfeeding form at the postpartum day 2 timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)</title>
          <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
          <population>This population includes all participants who completed the electronically administered breastfeeding form at the postpartum day 2 timepoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0452</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)</title>
        <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
        <time_frame>6 weeks postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered breastfeeding form at the 6 week timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)</title>
          <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
          <population>This population includes all participants who completed the electronically administered breastfeeding form at the 6 week timepoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0899</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)</title>
        <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
        <time_frame>3 months postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered breastfeeding form at the 3 month timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)</title>
          <description>Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.</description>
          <population>This population includes all participants who completed the electronically administered breastfeeding form at the 3 month timepoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1265</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent-Infant Attachment (MPAS)</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.</description>
        <time_frame>6 weeks postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered MPAS at the 6 week timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Parent-Infant Attachment (MPAS)</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.</description>
          <population>This population includes all participants who completed the electronically administered MPAS at the 6 week timepoint.</population>
          <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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.09" spread="5.48"/>
                    <measurement group_id="O2" value="87.68" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0328</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent-Infant Attachment (MPAS)</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.</description>
        <time_frame>3 months postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered MPAS at the 3 month timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Parent-Infant Attachment (MPAS)</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.</description>
          <population>This population includes all participants who completed the electronically administered MPAS at the 3 month timepoint.</population>
          <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="15"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.08" spread="4.01"/>
                    <measurement group_id="O2" value="88.70" spread="4.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6824</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Development (ASQ-3) Personal Social Score</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.</description>
        <time_frame>6 weeks postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered ASQ at the 6 week timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Child Development (ASQ-3) Personal Social Score</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.</description>
          <population>This population includes all participants who completed the electronically administered ASQ at the 6 week timepoint.</population>
          <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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.64" spread="11.15"/>
                    <measurement group_id="O2" value="46.04" spread="10.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.449</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Development (ASQ-3) Personal Social Score</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.</description>
        <time_frame>3 months postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered ASQ at the 3 month timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Child Development (ASQ-3) Personal Social Score</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.</description>
          <population>This population includes all participants who completed the electronically administered ASQ at the 3 month timepoint.</population>
          <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="15"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.00" spread="14.85"/>
                    <measurement group_id="O2" value="47.33" spread="10.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5996</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parenting Self-efficacy (PMP-SE)</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.</description>
        <time_frame>6 weeks postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered PMP-SE at the 6 week timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Parenting Self-efficacy (PMP-SE)</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.</description>
          <population>This population includes all participants who completed the electronically administered PMP-SE at the 6 week timepoint.</population>
          <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="22"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.45" spread="6.54"/>
                    <measurement group_id="O2" value="71.92" spread="5.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8009</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parenting Self-Efficacy (PMP-SE)</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.</description>
        <time_frame>3 months postpartum</time_frame>
        <population>This population includes all participants who completed the electronically administered PMP-SE at the 3 month timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Parenting Self-Efficacy (PMP-SE)</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.</description>
          <population>This population includes all participants who completed the electronically administered PMP-SE at the 3 month timepoint.</population>
          <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="15"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.20" spread="5.92"/>
                    <measurement group_id="O2" value="74.48" spread="6.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5422</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Edinburgh Postnatal Depression Score (EPDS)</title>
        <description>Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.</description>
        <time_frame>3 months</time_frame>
        <population>This population includes all participants who completed the electronically administered EPDS at the 3 month timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Spinal Epidural (CSE)</title>
            <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
          </group>
          <group group_id="O2">
            <title>Epidural</title>
            <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</description>
          </group>
        </group_list>
        <measure>
          <title>Edinburgh Postnatal Depression Score (EPDS)</title>
          <description>Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.</description>
          <population>This population includes all participants who completed the electronically administered EPDS at the 3 month timepoint.</population>
          <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="15"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.53" spread="3.93"/>
                    <measurement group_id="O2" value="3.96" spread="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7374</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data on adverse events were collected during the period of subject participation (e.g., 3rd trimester until 3 months postpartum, or labor until 3 months postpartum).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Combined Spinal Epidural (CSE)</title>
          <description>intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
CSE&#xD;
Bupivacaine / fentaNYL</description>
        </group>
        <group group_id="E2">
          <title>Epidural</title>
          <description>epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL&#xD;
Epidural&#xD;
Bupivacaine / fentaNYL</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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Dr. Grace Lim</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-641-2179</phone>
      <email>limkg2@upmc.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/NCT03022526
org study id: PRO16060602
nct id: NCT03022526
lead sponsor: 
has dmc: No
The purpose of this pilot prospective randomized control trial is to compare the initiation
      of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on
      risk for postpartum depression symptoms. Investigators will randomize women to the receipt of
      CSE or E during labor, after measuring baseline psychological, psychosocial, and
      psychophysical factors related to pain and depression. The immediate research goals are to
      understand whether the association between labor pain and PPD is modifiable through the use
      of tailored anesthetic techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Edinburgh Postnatal Depression Score (EPDS)
time frame: 6 weeks
description: Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.
measure: Pain Score on Average (BPI - Short Form)
time frame: 2 days postpartum
description: Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered "yes" to question: "Have you had pain other than everyday kinds of pain today?"
measure: Pain Score on Average (BPI - Short Form)
time frame: 6 weeks postpartum
description: Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered "yes" to question: "Have you had pain other than everyday kinds of pain today?"
measure: Pain Score on Average (BPI - Short Form)
time frame: 3 months postpartum
description: Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered "yes" to question: "Have you had pain other than everyday kinds of pain today?"
measure: Perceived Stress (PSS)
time frame: 2 days postpartum
description: Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.
measure: Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)
time frame: 2 Days Postpartum
description: Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
measure: Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)
time frame: 6 weeks postpartum
description: Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
measure: Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)
time frame: 3 months postpartum
description: Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
measure: Parent-Infant Attachment (MPAS)
time frame: 6 weeks postpartum
description: Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
measure: Parent-Infant Attachment (MPAS)
time frame: 3 months postpartum
description: Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
measure: Child Development (ASQ-3) Personal Social Score
time frame: 6 weeks postpartum
description: Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.
measure: Child Development (ASQ-3) Personal Social Score
time frame: 3 months postpartum
description: Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.
measure: Parenting Self-efficacy (PMP-SE)
time frame: 6 weeks postpartum
description: Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
measure: Parenting Self-Efficacy (PMP-SE)
time frame: 3 months postpartum
description: Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
measure: Edinburgh Postnatal Depression Score (EPDS)
time frame: 3 months
description: Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.
arm group label: CSE
arm group type: Experimental
description: intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
arm group label: Epidural
arm group type: Active Comparator
description: epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
intervention type: Procedure
intervention name: CSE
arm group label: CSE
intervention type: Procedure
intervention name: Epidural
arm group label: Epidural
intervention type: Drug
intervention name: Bupivacaine / fentaNYL
arm group label: CSE
arm group label: Epidural
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Centers for Disease Control and Prevention (CDC). Prevalence of self-reported postpartum depressive symptoms--17 states, 2004-2005. MMWR Morb Mortal Wkly Rep. 2008 Apr 11;57(14):361-6.
PMID: 18401329
citation: Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.
PMID: 23487258
citation: Logsdon MC, Wisner KL, Pinto-Foltz MD. The impact of postpartum depression on mothering. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):652-8. doi: 10.1111/j.1552-6909.2006.00087.x.
PMID: 16958723
citation: Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
PMID: 24797120
citation: Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
PMID: 15234824
citation: Righetti-Veltema M, Conne-Perreard E, Bousquet A, Manzano J. Risk factors and predictive signs of postpartum depression. J Affect Disord. 1998 Jun;49(3):167-80. doi: 10.1016/s0165-0327(97)00110-9.
PMID: 9629946
citation: O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002. Epub 2013 Oct 7.
PMID: 24140480
citation: Chapman C. The Psychophysiology of Pain by C. Richard Chapman. In: Fishman S, Ballantyne J, Rathmell JP, editors. Bonica's Management of Pain. Fourth ed. Baltimore, MD: Lippincott Williams & Wilkins; 2010. p. 375
citation: Gross KH, Wells CS, Radigan-Garcia A, Dietz PM. Correlates of self-reports of being very depressed in the months after delivery: results from the Pregnancy Risk Assessment Monitoring System. Matern Child Health J. 2002 Dec;6(4):247-53. doi: 10.1023/a:1021110100339.
PMID: 12512766
citation: O'Hara M, Swain A. Rates and risk of postpartum depression-A meta-analysis. Int Rev Psychiatry. 1996;8:37-54
citation: Schmidt RM, Wiemann CM, Rickert VI, Smith EO. Moderate to severe depressive symptoms among adolescent mothers followed four years postpartum. J Adolesc Health. 2006 Jun;38(6):712-8. doi: 10.1016/j.jadohealth.2005.05.023.
PMID: 16730600
citation: Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33.
PMID: 20949886
citation: Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.
PMID: 19318144
citation: Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
PMID: 15883651
citation: Davalos DB, Yadon CA, Tregellas HC. Untreated prenatal maternal depression and the potential risks to offspring: a review. Arch Womens Ment Health. 2012 Feb;15(1):1-14. doi: 10.1007/s00737-011-0251-1. Epub 2012 Jan 4.
PMID: 22215285
citation: Murray L, Arteche A, Fearon P, Halligan S, Goodyer I, Cooper P. Maternal postnatal depression and the development of depression in offspring up to 16 years of age. J Am Acad Child Adolesc Psychiatry. 2011 May;50(5):460-70. doi: 10.1016/j.jaac.2011.02.001. Epub 2011 Apr 5.
PMID: 21515195
citation: Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, O'Connor TG, Stein A. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA Psychiatry. 2013 Dec;70(12):1312-9. doi: 10.1001/jamapsychiatry.2013.2163.
PMID: 24108418
citation: Melzack R. The myth of painless childbirth (the John J. Bonica lecture). Pain. 1984 Aug;19(4):321-337. doi: 10.1016/0304-3959(84)90079-4. No abstract available.
PMID: 6384895
citation: Boudou M, Teissedre F, Walburg V, Chabrol H. [Association between the intensity of childbirth pain and the intensity of postpartum blues]. Encephale. 2007 Oct;33(5):805-10. doi: 10.1016/j.encep.2006.10.002. French.
PMID: 18357852
citation: Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PMID: 18818022
citation: Hiltunen P, Raudaskoski T, Ebeling H, Moilanen I. Does pain relief during delivery decrease the risk of postnatal depression? Acta Obstet Gynecol Scand. 2004 Mar;83(3):257-61. doi: 10.1111/j.0001-6349.2004.0302.x.
PMID: 14995921
citation: Vigod SN, Villegas L, Dennis CL, Ross LE. Prevalence and risk factors for postpartum depression among women with preterm and low-birth-weight infants: a systematic review. BJOG. 2010 Apr;117(5):540-50. doi: 10.1111/j.1471-0528.2009.02493.x. Epub 2010 Jan 29.
PMID: 20121831
citation: Ross LE, McQueen K, Vigod S, Dennis CL. Risk for postpartum depression associated with assisted reproductive technologies and multiple births: a systematic review. Hum Reprod Update. 2011 Jan-Feb;17(1):96-106. doi: 10.1093/humupd/dmq025. Epub 2010 Jul 6.
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citation: Howard LM, Oram S, Galley H, Trevillion K, Feder G. Domestic violence and perinatal mental disorders: a systematic review and meta-analysis. PLoS Med. 2013;10(5):e1001452. doi: 10.1371/journal.pmed.1001452. Epub 2013 May 28.
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citation: Sanger C, Iles JE, Andrew CS, Ramchandani PG. Associations between postnatal maternal depression and psychological outcomes in adolescent offspring: a systematic review. Arch Womens Ment Health. 2015 Apr;18(2):147-162. doi: 10.1007/s00737-014-0463-2. Epub 2014 Oct 2.
PMID: 25269760
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Grace Lim, MD, MS
investigator title: Assistant Professor of Anesthesiology
mesh term: Depression, Postpartum
mesh term: Labor Pain
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Fentanyl
mesh term: Bupivacaine
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 