<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/NCT02245386</url>
  </required_header>
  <id_info>
    <org_study_id>1781956</org_study_id>
    <nct_id>NCT02245386</nct_id>
  </id_info>
  <brief_title>Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women</brief_title>
  <official_title>Effects of Pregnancy and Parturition on Pelvic Floor Morphology and Sexual Function in Egyptian Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean&#xD;
      section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and&#xD;
      to study the effect of mode of delivery on female sexual function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. transperineal pelvic floor ultrasound applied for the submitted 120 women &quot;primiparae&quot;&#xD;
           (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40&#xD;
           women after elective cesarean section), in early postpartum period (48 to 72) hours&#xD;
           postpartum, to evaluate levator ani morphology.&#xD;
&#xD;
        2. answering of the validated female sexual function index (F.S.F.I) three months&#xD;
           postpartum period for same cases submitted to ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound</measure>
    <time_frame>early postpartum period (48 to 72) hours postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sexual function of pelvic floor as assessed by the validated female sexual function index</measure>
    <time_frame>at 3 months after delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound</measure>
    <time_frame>6 months after delivery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function as assessed by the validated female sexual function index</measure>
    <time_frame>3 months after delivery</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Pregnancy, Childbirth and Puerperal Disorders</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>(40 women after normal vaginal delivery) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>(40 women after urgent cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>(40 women after elective cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>transperineal pelvic floor ultrasound</intervention_name>
    <description>Transperineal pelvic floor ultrasound applied for the submitted 120 women &quot;primiparae&quot; (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primiparae in early postpartum period (48 hours to72 hours). written consent was taken.&#xD;
        easy communicable, reachable women for further requirements.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primiparae in early postpartum period (48 hours to72 hours). written consent was&#xD;
             taken. easy communicable, reachable women for further requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Refused consent.&#xD;
&#xD;
          2. Previous vaginal or cesarean delivery.&#xD;
&#xD;
          3. Severe mental illness.&#xD;
&#xD;
          4. Severe physical handicap or difficulties in communication.&#xD;
&#xD;
          5. Women without postpartum active sexual life or separate from their spouse.&#xD;
&#xD;
          6. Past history of sexual dysfunction.&#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>Muhamed Osman, Ms</last_name>
    <role>Principal Investigator</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Muhamed Osman</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puerperal Disorders</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/NCT02245386
org study id: 1781956
nct id: NCT02245386
lead sponsor: 
has dmc: Yes
To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean
      section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and
      to study the effect of mode of delivery on female sexual function.
1. transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae"
           (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40
           women after elective cesarean section), in early postpartum period (48 to 72) hours
           postpartum, to evaluate levator ani morphology.

        2. answering of the validated female sexual function index (F.S.F.I) three months
           postpartum period for same cases submitted to ultrasound.
time perspective: Cross-Sectional
measure: Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound
time frame: early postpartum period (48 to 72) hours postpartum
measure: Sexual function of pelvic floor as assessed by the validated female sexual function index
time frame: at 3 months after delivery
measure: Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound
time frame: 6 months after delivery.
measure: Sexual function as assessed by the validated female sexual function index
time frame: 3 months after delivery
arm group label: Group 1
description: (40 women after normal vaginal delivery) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.
arm group label: Group 2
description: (40 women after urgent cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.
arm group label: Group 3
description: (40 women after elective cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum.
intervention type: Radiation
intervention name: transperineal pelvic floor ultrasound
description: Transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae" (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Muhamed Osman, Ms
role: Principal Investigator
affiliation: Al-Azhar University
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Muhamed Osman
investigator title: Dr
mesh term: Puerperal Disorders