<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/NCT03004872</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00119428</org_study_id>
    <nct_id>NCT03004872</nct_id>
  </id_info>
  <brief_title>Relationship Between Postpartum Mood Disorders and Delivery Experience</brief_title>
  <official_title>Relationship Between Postpartum Mood Disorders and Delivery Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate potential risk factors for developing postpartum&#xD;
      depression or posttraumatic stress disorder during the first year postpartum in patients who&#xD;
      have no preexisting history of PTSD or PPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is theorized that poor pain control during labor and cesarean delivery, non-elective&#xD;
      inductions, unplanned surgeries such as urgent/emergent cesarean delivery or operating room&#xD;
      management of postpartum hemorrhage, and opioid abuse/addiction are risk factors for&#xD;
      developing postpartum depression (PPD) or post-traumatic stress disorder (PTSD) after&#xD;
      delivery. This study will, through questionnaires, interviews, and examination of the medical&#xD;
      record, seek to identify whether and how strongly such correlations exist during the first&#xD;
      year postpartum in patients who have no preexisting history of these conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2016</start_date>
  <completion_date type="Actual">December 17, 2018</completion_date>
  <primary_completion_date type="Actual">December 17, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association of poor birth experiences with development of postpartum posttraumatic stress disorder (PTSD).</measure>
    <time_frame>1 year postpartum</time_frame>
    <description>Enrollees will receive questionnaires for Perinatal Posttraumatic Stress Disorder (PPQ) screenings 6 weeks, 3 months, 6 months, and 1 year postpartum. Positive screens are defined as PPQ&gt;19. PPQ&gt;13 will be considered as subsyndromal. At each screening, patients with positive scores will be interviewed to diagnose PTSD and to look for thematic similarities in birth experiences. Patients' medical charts will be reviewed for 4 clinical events: Pain scores &gt;5 with a labor epidural in place; Pain during cesarean delivery requiring general anesthesia, IV narcotics, ketamine, midazolam, nitrous oxide, or reassurance; Non-elective inductions of labor; and Unplanned surgery including urgent/emergent cesarean delivery and postpartum hemorrhage requiring operating room management. Statistical analysis of all 4 PPQ scores and evaluation of clinical birth events will be performed to determine the association of poor birth experiences with postpartum depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Association of poor birth experience with development of postpartum depression.</measure>
    <time_frame>1 year postpartum</time_frame>
    <description>Enrollees will receive questionnaires for Edinburgh Postnatal Depression Scale (EPDS) screenings at 6 weeks, 3 months, 6 months, and 1 year postpartum. Positive screens are defined as EPDS score &gt;10 or a positive response for question 10 asking about suicidality. At each screening, patients with positive scores will be interviewed to diagnose depression and to look for thematic similarities in birth experiences. Patients' medical charts will be reviewed for 4 clinical events: Pain scores &gt;5 with a labor epidural in place; Pain during cesarean delivery requiring general anesthesia, IV narcotics, ketamine, midazolam, nitrous oxide, or reassurance; Non-elective inductions of labor; and Unplanned surgery including urgent/emergent cesarean delivery and postpartum hemorrhage requiring operating room management. Statistical analysis of all 4 EPDS scores and evaluation of clinical birth events will be performed to determine the association of poor birth experiences with postpartum depression.</description>
  </primary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Postpartum Period</condition>
  <condition>Depression</condition>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who are planning to give birth at the University of Michigan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman planning on giving birth at the University of Michigan&#xD;
&#xD;
          -  Speaks English without translator&#xD;
&#xD;
          -  Live pregnancy not desiring termination&#xD;
&#xD;
          -  Smartphone owner&#xD;
&#xD;
          -  Woman whose delivery date is &gt;28 weeks gestational age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous postpartum depression (PPD) or posttraumatic stress disorder&#xD;
             (PTSD) from a birth experience&#xD;
&#xD;
          -  Non-English speaker requiring a translator&#xD;
&#xD;
          -  Patients who have a fetus with major fetal anomalies&#xD;
&#xD;
          -  Positive screening at 28 weeks antepartum for Edinburgh Postnatal Depression Scale&#xD;
             (EPDS) or Primary Care PTSD (PC-PTSD) screen&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanna Kountanis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Langen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Joanna Kountanis</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>birth experience</keyword>
  <keyword>postpartum depression</keyword>
  <keyword>PTSD</keyword>
  <keyword>pain during labor</keyword>
  <keyword>pain during cesarean delivery</keyword>
  <keyword>non-elective induction of labor</keyword>
  <keyword>unplanned surgery for urgent/emergent cesarean delivery</keyword>
  <keyword>postpartum hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004872
org study id: HUM00119428
nct id: NCT03004872
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate potential risk factors for developing postpartum
      depression or posttraumatic stress disorder during the first year postpartum in patients who
      have no preexisting history of PTSD or PPD.
It is theorized that poor pain control during labor and cesarean delivery, non-elective
      inductions, unplanned surgeries such as urgent/emergent cesarean delivery or operating room
      management of postpartum hemorrhage, and opioid abuse/addiction are risk factors for
      developing postpartum depression (PPD) or post-traumatic stress disorder (PTSD) after
      delivery. This study will, through questionnaires, interviews, and examination of the medical
      record, seek to identify whether and how strongly such correlations exist during the first
      year postpartum in patients who have no preexisting history of these conditions.
observational model: Cohort
time perspective: Prospective
measure: Association of poor birth experiences with development of postpartum posttraumatic stress disorder (PTSD).
time frame: 1 year postpartum
description: Enrollees will receive questionnaires for Perinatal Posttraumatic Stress Disorder (PPQ) screenings 6 weeks, 3 months, 6 months, and 1 year postpartum. Positive screens are defined as PPQ>19. PPQ>13 will be considered as subsyndromal. At each screening, patients with positive scores will be interviewed to diagnose PTSD and to look for thematic similarities in birth experiences. Patients' medical charts will be reviewed for 4 clinical events: Pain scores >5 with a labor epidural in place; Pain during cesarean delivery requiring general anesthesia, IV narcotics, ketamine, midazolam, nitrous oxide, or reassurance; Non-elective inductions of labor; and Unplanned surgery including urgent/emergent cesarean delivery and postpartum hemorrhage requiring operating room management. Statistical analysis of all 4 PPQ scores and evaluation of clinical birth events will be performed to determine the association of poor birth experiences with postpartum depression.
measure: Association of poor birth experience with development of postpartum depression.
time frame: 1 year postpartum
description: Enrollees will receive questionnaires for Edinburgh Postnatal Depression Scale (EPDS) screenings at 6 weeks, 3 months, 6 months, and 1 year postpartum. Positive screens are defined as EPDS score >10 or a positive response for question 10 asking about suicidality. At each screening, patients with positive scores will be interviewed to diagnose depression and to look for thematic similarities in birth experiences. Patients' medical charts will be reviewed for 4 clinical events: Pain scores >5 with a labor epidural in place; Pain during cesarean delivery requiring general anesthesia, IV narcotics, ketamine, midazolam, nitrous oxide, or reassurance; Non-elective inductions of labor; and Unplanned surgery including urgent/emergent cesarean delivery and postpartum hemorrhage requiring operating room management. Statistical analysis of all 4 EPDS scores and evaluation of clinical birth events will be performed to determine the association of poor birth experiences with postpartum depression.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanna Kountanis, MD
role: Principal Investigator
affiliation: University of Michigan
last name: Elizabeth Langen, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Joanna Kountanis
investigator title: Assistant Professor
mesh term: Depression
mesh term: Mood Disorders
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No