<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/NCT04474275</url>
  </required_header>
  <id_info>
    <org_study_id>Mode of Delivery</org_study_id>
    <nct_id>NCT04474275</nct_id>
  </id_info>
  <brief_title>The Effect of the Mode of Delivery to the Pelvic Floor Function</brief_title>
  <official_title>The Effect of the Mode of Delivery to the Pelvic Floor Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Giresun University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Giresun 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>
      The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the&#xD;
      pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries.&#xD;
      The investigators wondered if the mode of deliveries such as ceserean section, vaginal route&#xD;
      delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor&#xD;
      function differently or not. In order to evaluate this, the investigators are planning to&#xD;
      measure the muscle tonus in primiparous women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">September 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic floor muscle tonus</measure>
    <time_frame>25.05.2020- 25.08.2020</time_frame>
    <description>Pelvic floor muscle tonus is going to measure by vaginal perineometry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Female sexual function</measure>
    <time_frame>25.05.2020- 25.08.2020</time_frame>
    <description>Female sexual function is going to evaluate by validated FSFI questionnaire</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Incontinence</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Study group 1</arm_group_label>
    <description>Primiparous women who gave birth with ceserean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group 2</arm_group_label>
    <description>Primiparous women who gave birth with vaginal route delivery without episiotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group 3</arm_group_label>
    <description>Primiparous women who gave birth with vaginal route delivery with episiotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Nulliparous women</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        18-40 years old primiparous women who gave birth 5-10 years ago.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primiparous women 5-10 years after birth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiparous women Women with connective tissue disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only primiparous women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sebnem Alanya Tosun</name>
      <address>
        <city>Giresun</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Giresun University</investigator_affiliation>
    <investigator_full_name>Sebnem Alanya Tosun</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>pelvic organ prolapse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</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/NCT04474275
org study id: Mode of Delivery
nct id: NCT04474275
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the
      pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries.
      The investigators wondered if the mode of deliveries such as ceserean section, vaginal route
      delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor
      function differently or not. In order to evaluate this, the investigators are planning to
      measure the muscle tonus in primiparous women.
observational model: Case-Control
time perspective: Prospective
measure: Pelvic floor muscle tonus
time frame: 25.05.2020- 25.08.2020
description: Pelvic floor muscle tonus is going to measure by vaginal perineometry.
measure: Female sexual function
time frame: 25.05.2020- 25.08.2020
description: Female sexual function is going to evaluate by validated FSFI questionnaire
arm group label: Study group 1
description: Primiparous women who gave birth with ceserean section
arm group label: Study group 2
description: Primiparous women who gave birth with vaginal route delivery without episiotomy
arm group label: Study group 3
description: Primiparous women who gave birth with vaginal route delivery with episiotomy
arm group label: Control group
description: Nulliparous women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only primiparous women
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Giresun University
investigator full name: Sebnem Alanya Tosun
investigator title: Assistant Professor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse