<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/NCT03763435</url>
  </required_header>
  <id_info>
    <org_study_id>Bartin2018-3</org_study_id>
    <nct_id>NCT03763435</nct_id>
  </id_info>
  <brief_title>The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression</brief_title>
  <official_title>The Effects of Pregnancy Classes on Postpartum Depression and Contributing Factors to Postpartum Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartin State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bartin State Hospital</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>
      It is recommended by the American College of Obstetricians and Gynecologists' Committee on&#xD;
      Obstetric Practice that all obstetricians screen each women for postpartum depression and&#xD;
      anxiety with a validated instrument. Although much effort is made, the contributing factors&#xD;
      still lack in the literature due to its multi-factorial nature and complexity.&#xD;
&#xD;
      In addition, the effects of prenatal education classes remain understudied. Therefore, this&#xD;
      study aims to demonstrate the prevalence, characteristics and contributing factors of the&#xD;
      postpartum depression. In addition, the change in prevalence and characteristics of the&#xD;
      postpartum depression among women who had prenatal classes and not will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific and validated instruments will be performed to women in their 8th week of postpartum&#xD;
      period.&#xD;
&#xD;
      Those instruments are:&#xD;
&#xD;
      Edinburgh Postpartum Depression Scale (EPDS) Female genital self-image scale (FGSIS) Insomnia&#xD;
      Severity Index (ISI) Breast-feeding efficacy scale short form (BSES-SF) Beck Depression Scale&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Anticipated">July 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postpartum Depression</measure>
    <time_frame>Change between the 4th, 8th and 12th weeks of postpartum period</time_frame>
    <description>Postpartum Depression scores will be measured by Edinburgh Postpartum Scale (EDPS). The EDPS was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 . The maximum score is 30. The EPDS is a 10-item questionnaire. Women are asked to answer each question in terms of the past seven days. A score is calculated by adding the individual items as indicated A score of more than 10 suggests minor or major depression may be present.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genital self-image</measure>
    <time_frame>At 4th, 8th and 12th week of postpartum period</time_frame>
    <description>Genital Self-image scores will be measured by Female Genital Self Image Scale (FGSIS). FGSIS measures the genital self-image of the participants.&#xD;
The seven-item FGSIS assesses women's feelings and beliefs about their own genitals using a 4-point response scale (strongly agree, agree, disagree, strongly disagree).&#xD;
Respondents'scores on each item were summed for a total sum score ranging from 7 to 28, with higher scores indicating more positive genital self-image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep disorders</measure>
    <time_frame>At 4th, 8th and 12th week of postpartum period</time_frame>
    <description>Sleep problems will be measured by Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>breast-feeding</measure>
    <time_frame>At 4th, 8th and 12th week of postpartum period</time_frame>
    <description>Breast-feeding will be assessed by the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). It is a 14 item self-report instrument developed to measure a mother's perceived ability to breastfeed her infant. It has a five-point Likert scale for rating from 1 (&quot;not at all confident&quot;) to 5 (&quot;always confident&quot;). Items ratings will be summed to produce a total score from 14 to 70, with higher scores indicating higher confidence. The means score points will be used as the cut-off point between high and low scorers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>socio-economic-demographical features</measure>
    <time_frame>At 4th postpartum week</time_frame>
    <description>Social, economic and demographic features will be assessed by a structured non-validated data gathering form</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Postpartum Depression</condition>
  <condition>Sleep Disorder</condition>
  <condition>Breast Feeding</condition>
  <condition>Self Esteem</condition>
  <arm_group>
    <arm_group_label>Antenatal Classes Received</arm_group_label>
    <description>Women who are involved into at least 3 comprehensive session of Antenatal pregnancy classes (educational) during the prenatal period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without education</arm_group_label>
    <description>Groups are not randomized for not to give rise to ethical problems in order to maximize the community health care. Only women who are not involved into the educational classes due to their inaccessibility related to their own conditions or wishes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Antenatal pregnancy classes</intervention_name>
    <description>At least three comprehensive full-day educational program covering all the stages of pregnancy.</description>
    <arm_group_label>Antenatal Classes Received</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All women who gave birth in Bartin State Hospital (the only one hospital in the city) after&#xD;
        October 2018. for three months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women in the puerpera period (who gave consent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murat Yassa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bartin State Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Murat Yassa, MD</last_name>
    <phone>+905335106312</phone>
    <email>murat.yassa@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bartin State Hospital</name>
      <address>
        <city>Bartin</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Murat Yassa, MD</last_name>
    </contact>
    <investigator>
      <last_name>Nahide YAZICI, Midwife</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302.</citation>
    <PMID>21569372</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 21, 2019</last_update_submitted>
  <last_update_submitted_qc>April 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bartin State Hospital</investigator_affiliation>
    <investigator_full_name>Murat Yassa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>postpartum depression</keyword>
  <keyword>sleep disorder</keyword>
  <keyword>genital self-image</keyword>
  <keyword>breast-feeding</keyword>
  <keyword>prevalence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03763435
org study id: Bartin2018-3
nct id: NCT03763435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is recommended by the American College of Obstetricians and Gynecologists' Committee on
      Obstetric Practice that all obstetricians screen each women for postpartum depression and
      anxiety with a validated instrument. Although much effort is made, the contributing factors
      still lack in the literature due to its multi-factorial nature and complexity.

      In addition, the effects of prenatal education classes remain understudied. Therefore, this
      study aims to demonstrate the prevalence, characteristics and contributing factors of the
      postpartum depression. In addition, the change in prevalence and characteristics of the
      postpartum depression among women who had prenatal classes and not will also be assessed.
Specific and validated instruments will be performed to women in their 8th week of postpartum
      period.

      Those instruments are:

      Edinburgh Postpartum Depression Scale (EPDS) Female genital self-image scale (FGSIS) Insomnia
      Severity Index (ISI) Breast-feeding efficacy scale short form (BSES-SF) Beck Depression Scale
observational model: Case-Control
time perspective: Cross-Sectional
measure: Postpartum Depression
time frame: Change between the 4th, 8th and 12th weeks of postpartum period
description: Postpartum Depression scores will be measured by Edinburgh Postpartum Scale (EDPS). The EDPS was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 . The maximum score is 30. The EPDS is a 10-item questionnaire. Women are asked to answer each question in terms of the past seven days. A score is calculated by adding the individual items as indicated A score of more than 10 suggests minor or major depression may be present.
measure: Genital self-image
time frame: At 4th, 8th and 12th week of postpartum period
description: Genital Self-image scores will be measured by Female Genital Self Image Scale (FGSIS). FGSIS measures the genital self-image of the participants.
The seven-item FGSIS assesses women's feelings and beliefs about their own genitals using a 4-point response scale (strongly agree, agree, disagree, strongly disagree).
Respondents'scores on each item were summed for a total sum score ranging from 7 to 28, with higher scores indicating more positive genital self-image.
measure: sleep disorders
time frame: At 4th, 8th and 12th week of postpartum period
description: Sleep problems will be measured by Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
measure: breast-feeding
time frame: At 4th, 8th and 12th week of postpartum period
description: Breast-feeding will be assessed by the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). It is a 14 item self-report instrument developed to measure a mother's perceived ability to breastfeed her infant. It has a five-point Likert scale for rating from 1 ("not at all confident") to 5 ("always confident"). Items ratings will be summed to produce a total score from 14 to 70, with higher scores indicating higher confidence. The means score points will be used as the cut-off point between high and low scorers.
measure: socio-economic-demographical features
time frame: At 4th postpartum week
description: Social, economic and demographic features will be assessed by a structured non-validated data gathering form
arm group label: Antenatal Classes Received
description: Women who are involved into at least 3 comprehensive session of Antenatal pregnancy classes (educational) during the prenatal period.
arm group label: Without education
description: Groups are not randomized for not to give rise to ethical problems in order to maximize the community health care. Only women who are not involved into the educational classes due to their inaccessibility related to their own conditions or wishes.
intervention type: Behavioral
intervention name: Antenatal pregnancy classes
description: At least three comprehensive full-day educational program covering all the stages of pregnancy.
arm group label: Antenatal Classes Received
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Murat Yassa, MD
role: Principal Investigator
affiliation: Bartin State Hospital
last name: Murat Yassa, MD
phone: +905335106312
email: murat.yassa@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
citation: Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302.
PMID: 21569372
responsible party type: Principal Investigator
investigator affiliation: Bartin State Hospital
investigator full name: Murat Yassa
investigator title: Principal Investigator
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Undecided