<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/NCT04427410</url>
  </required_header>
  <id_info>
    <org_study_id>TYL-2019-12476</org_study_id>
    <nct_id>NCT04427410</nct_id>
  </id_info>
  <brief_title>The Relationship Between Oxytocin Level and Postpartum Depression</brief_title>
  <official_title>The Relationship Between Oxytocin Level Measured During Pregnancy and Postpartum Depression Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ayseren Cevik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cukurova University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are studies in the literature that associate oxytocin level with postpartum depression.&#xD;
      This study was carried out to investigate the relationship between oxytocin levels measured&#xD;
      during pregnancy and postpartum depression symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction and purpose: There are studies in the literature that associate oxytocin level&#xD;
      with postpartum depression. This study was carried out to investigate the relationship&#xD;
      between oxytocin levels measured during pregnancy and postpartum depression symptoms.&#xD;
&#xD;
      Method: The study was conducted with 70 women who met the research criteria. Data collection&#xD;
      was done in two interviews. The first meeting is 30-38 at the week of gestation, the second&#xD;
      interview is 4-12 at the week of postpartum. It was done between weeks. In each interview, a&#xD;
      data collection form was applied first and then a saliva sample was taken. Data collection&#xD;
      form; The questions prepared by the researchers consisted of the Edinburgh Postnatal&#xD;
      Depression Scale (EPDS) and Beck Depression Inventory (BDI). The data were analyzed using&#xD;
      SPSS 22.0 program and the significance value was taken as p &lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2019</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2019</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>Oxytocin levels</measure>
    <time_frame>3-6 month</time_frame>
    <description>Oxytocin levels in pregnancy and postpartum period</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Oxytocin Deficiency</condition>
  <condition>Postpartum Depression</condition>
  <condition>Prenatal Stress</condition>
  <arm_group>
    <arm_group_label>pregnancy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>postpartum</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Salivary test</intervention_name>
    <description>Salivary test for measured of oxytocin levels</description>
    <arm_group_label>postpartum</arm_group_label>
    <arm_group_label>pregnancy</arm_group_label>
    <other_name>survey application</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Based on the study conducted by Eapen et al. (2014), for the relationship between oxytocin&#xD;
        and postpartum depression symptoms, based on the correlation coefficient for the periods&#xD;
        during and after pregnancy; For r = -0.35, a minimum sample size of 61 with 5% error and&#xD;
        80% power has been determined. Since there may be a quit situation during the study, the&#xD;
        sample size was determined as 67 by expanding it with a share of 10%.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older, and having a pregnancy of 30 weeks or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous mental illness history, miscarriage or stillbirth history, multiple&#xD;
             pregnancy, fetal malformation, antidepressant or anxiolytic drug use, existing chronic&#xD;
             disease,preterm labor is the development of maternal or neonatal complications at&#xD;
             birth, hospitalization in the neonatal intensive care unit or congenital disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnancy and postpartum period</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cukurova University</name>
      <address>
        <city>Adana</city>
        <state>Saricam</state>
        <zip>01330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Sultan Alan</investigator_full_name>
    <investigator_title>Associate Professor Dr</investigator_title>
  </responsible_party>
  <keyword>oxytocin</keyword>
  <keyword>Postpartum Depression</keyword>
  <keyword>oxytocin and depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT04427410
org study id: TYL-2019-12476
nct id: NCT04427410
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are studies in the literature that associate oxytocin level with postpartum depression.
      This study was carried out to investigate the relationship between oxytocin levels measured
      during pregnancy and postpartum depression symptoms.
Introduction and purpose: There are studies in the literature that associate oxytocin level
      with postpartum depression. This study was carried out to investigate the relationship
      between oxytocin levels measured during pregnancy and postpartum depression symptoms.

      Method: The study was conducted with 70 women who met the research criteria. Data collection
      was done in two interviews. The first meeting is 30-38 at the week of gestation, the second
      interview is 4-12 at the week of postpartum. It was done between weeks. In each interview, a
      data collection form was applied first and then a saliva sample was taken. Data collection
      form; The questions prepared by the researchers consisted of the Edinburgh Postnatal
      Depression Scale (EPDS) and Beck Depression Inventory (BDI). The data were analyzed using
      SPSS 22.0 program and the significance value was taken as p <0.05.
observational model: Cohort
time perspective: Prospective
measure: Oxytocin levels
time frame: 3-6 month
description: Oxytocin levels in pregnancy and postpartum period
arm group label: pregnancy
arm group label: postpartum
intervention type: Diagnostic Test
intervention name: Salivary test
description: Salivary test for measured of oxytocin levels
arm group label: postpartum
arm group label: pregnancy
other name: survey application
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnancy and postpartum period
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Sultan Alan
investigator title: Associate Professor Dr
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No