<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/NCT01700374</url>
  </required_header>
  <id_info>
    <org_study_id>812880</org_study_id>
    <secondary_id>P50MH099910</secondary_id>
    <nct_id>NCT01700374</nct_id>
  </id_info>
  <brief_title>Happy Mommy! Happy Baby! Study</brief_title>
  <acronym>FAP</acronym>
  <official_title>Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how difficult life-events that women experienced&#xD;
      during their childhood might affect their babies.&#xD;
&#xD;
      Women who are asked to participate in this study will fill out forms about their physical and&#xD;
      mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses&#xD;
      measured and have their baby's development and stress responses assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to further our understanding of maternal prepubertal&#xD;
      adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound&#xD;
      to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to&#xD;
      determine the degree of maternal stress and prepubertal adversity, and an acoustic startle&#xD;
      paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also&#xD;
      utilizes an infant stress test to assess infant arousal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">July 2022</completion_date>
  <primary_completion_date type="Actual">July 2022</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>Fetal Adrenal Size</measure>
    <time_frame>20 to 22 weeks gestational age</time_frame>
    <description>The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physiologic Arousal</measure>
    <time_frame>15 to 21 weeks gestational age and 6 to 8 weeks postpartum</time_frame>
    <description>The secondary outcomes are physiologic arousal based on the maternal response to the acoustic startle paradigm or TSST plus salivary cortisol at 15-17 weeks gestational age and 6-8 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiologic Arousal</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>The secondary outcomes are physiologic arousal based on infant stress responses as measured by the infant behavioral assessment and salivary cortisol at 6 months postpartum.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1506</enrollment>
  <condition>Pregnancy</condition>
  <condition>Stress, Psychological</condition>
  <condition>Stress, Physiological</condition>
  <condition>Maternal-fetal Relations</condition>
  <arm_group>
    <arm_group_label>Women without Prepubertal Adversity</arm_group_label>
    <description>At 8-17 weeks gestational age, 1,500 pregnant women will complete:&#xD;
Adverse Childhood Events (ACE) Questionnaire;&#xD;
Perceived Stress Scale (PSS);&#xD;
A general health and demographic questionnaire.&#xD;
All women who are screened will be asked if they would be willing to allow the study team to access their delivery report.&#xD;
Women who report 0 or 1 adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women with Prepubertal Adversity</arm_group_label>
    <description>At 8-17 weeks gestational age, 1,500 pregnant women will complete:&#xD;
Adverse Childhood Events (ACE) Questionnaire;&#xD;
Perceived Stress Scale (PSS);&#xD;
A general health and demographic questionnaire.&#xD;
All women who are screened will be asked if they would be willing to allow the study team to access their delivery report.&#xD;
Women who report 2 or more adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Salivary cortisol;&#xD;
&#xD;
        -  Blood plasma Corticotropin-releasing Hormone (CRH).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women from the greater Philadelphia and surrounding areas who are ages 18 - 45 and between&#xD;
        8 and 17 weeks pregnant will be considered for enrollment into this study. All subjects&#xD;
        must be physically healthy without a serious major medical illness, as well as be carrying&#xD;
        a healthy fetus. Subjects will be recruited through fliers, advertising, and social media&#xD;
        and may be directly approached at a University of Pennsylvania Health System (UPHS) or UPHS&#xD;
        affiliated obstetrics and gynecology clinic. We anticipate the composition of the proposed&#xD;
        study population to reflect the greater Philadelphia referral base. The projected&#xD;
        composition from Philadelphia is African American 42.58%, Hispanic 8.5%, Asian 4.42%, Other&#xD;
        2.04% and White, not of Hispanic Origin, 42.46%.&#xD;
&#xD;
        Additionally, we plan to include father's of the babies that are willing and able to&#xD;
        complete the ACE questionnaire.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 to 45 years;&#xD;
&#xD;
          -  Able to give written informed consent;&#xD;
&#xD;
          -  Between 8 to 17 weeks at time of recruitment;&#xD;
&#xD;
          -  Attendance at 20 week ultrasound at a UPHS site;&#xD;
&#xD;
          -  Healthy full term (35 6/7 weeks) infants;&#xD;
&#xD;
          -  Fluency in written and spoken English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a known abnormality in the present fetus, twin pregnancy or a multiple&#xD;
             pregnancy;&#xD;
&#xD;
          -  Presence of a serious medical or neurological illness, requiring treatment during&#xD;
             pregnancy;&#xD;
&#xD;
          -  Use of an antipsychotic or antidepressant medication anytime within 2 months prior to&#xD;
             the last menstrual period;&#xD;
&#xD;
          -  Drug or alcohol abuse history within previous 2 years;&#xD;
&#xD;
          -  Life-time history of psychotic disorder including, schizophrenia, schizoaffective&#xD;
             disorder; major depression with psychotic features and bipolar disorder&#xD;
&#xD;
          -  Active psychiatric illness requiring treatment based upon the clinical judgement of&#xD;
             the study psychiatrist;&#xD;
&#xD;
          -  Hamilton Depression Rating Scale Score &gt; 14;&#xD;
&#xD;
          -  Suicidal ideation within the previous 6 months;&#xD;
&#xD;
          -  Use of steroids drugs of antihypertensives during pregnancy as they could alter&#xD;
             physiologic arousal;&#xD;
&#xD;
          -  A history of preterm birth or history of preterm labor in the active pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia N Epperson, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>3701 Market Street</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Center for Women's Behavioral Wellness</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Medicine Washington Square (PMWS)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.med.upenn.edu/womenswellness/</url>
    <description>Program Website</description>
  </link>
  <results_reference>
    <citation>Morrison KE, Epperson CN, Sammel MD, Ewing G, Podcasy JS, Hantsoo L, Kim DR, Bale TL. Preadolescent Adversity Programs a Disrupted Maternal Stress Reactivity in Humans and Mice. Biol Psychiatry. 2017 Apr 15;81(8):693-701. doi: 10.1016/j.biopsych.2016.08.027. Epub 2016 Aug 26.</citation>
    <PMID>27776734</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>stress, psychological</keyword>
  <keyword>stress, physiological</keyword>
  <keyword>maternal-fetal relations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- 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/NCT01700374
org study id: 812880
secondary id: P50MH099910
nct id: NCT01700374
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine how difficult life-events that women experienced
      during their childhood might affect their babies.

      Women who are asked to participate in this study will fill out forms about their physical and
      mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses
      measured and have their baby's development and stress responses assessed.
The objectives of this study are to further our understanding of maternal prepubertal
      adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound
      to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to
      determine the degree of maternal stress and prepubertal adversity, and an acoustic startle
      paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also
      utilizes an infant stress test to assess infant arousal.
observational model: Cohort
time perspective: Prospective
measure: Fetal Adrenal Size
time frame: 20 to 22 weeks gestational age
description: The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.
measure: Physiologic Arousal
time frame: 15 to 21 weeks gestational age and 6 to 8 weeks postpartum
description: The secondary outcomes are physiologic arousal based on the maternal response to the acoustic startle paradigm or TSST plus salivary cortisol at 15-17 weeks gestational age and 6-8 weeks postpartum.
measure: Physiologic Arousal
time frame: 6 months postpartum
description: The secondary outcomes are physiologic arousal based on infant stress responses as measured by the infant behavioral assessment and salivary cortisol at 6 months postpartum.
arm group label: Women without Prepubertal Adversity
description: At 8-17 weeks gestational age, 1,500 pregnant women will complete:
Adverse Childhood Events (ACE) Questionnaire;
Perceived Stress Scale (PSS);
A general health and demographic questionnaire.
All women who are screened will be asked if they would be willing to allow the study team to access their delivery report.
Women who report 0 or 1 adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort.
arm group label: Women with Prepubertal Adversity
description: At 8-17 weeks gestational age, 1,500 pregnant women will complete:
Adverse Childhood Events (ACE) Questionnaire;
Perceived Stress Scale (PSS);
A general health and demographic questionnaire.
All women who are screened will be asked if they would be willing to allow the study team to access their delivery report.
Women who report 2 or more adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort.
-  Salivary cortisol;

        -  Blood plasma Corticotropin-releasing Hormone (CRH).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia N Epperson, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.med.upenn.edu/womenswellness/
description: Program Website
citation: Morrison KE, Epperson CN, Sammel MD, Ewing G, Podcasy JS, Hantsoo L, Kim DR, Bale TL. Preadolescent Adversity Programs a Disrupted Maternal Stress Reactivity in Humans and Mice. Biol Psychiatry. 2017 Apr 15;81(8):693-701. doi: 10.1016/j.biopsych.2016.08.027. Epub 2016 Aug 26.
PMID: 27776734
responsible party type: Sponsor
mesh term: Stress, Psychological