xml: <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/NCT06019962</url>
    </required_header>
    <id_info>
      <org_study_id>Pelvic Tilting</org_study_id>
      <nct_id>NCT06019962</nct_id>
    </id_info>
    <brief_title>Pelvic Tilt Following Puerperium</brief_title>
    <official_title>Measurement of Pelvic Tilt 6 Weeks Post-Cesarean Delivery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>South Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South Valley University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The slight anterior pelvic tilt is a physiological posture in healthy males and females,&#xD;
        however, excessive anterior pelvic tilt is associated with different lumbopelvic discomfort&#xD;
        either during gestation or after childbirth.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As pregnant women move from the 1st to the 3rd trimester, they exhibit a notable increase in&#xD;
        the angle of pelvic tilting. This may explain the painful pelvic girdle syndrome during&#xD;
        gestation which can last for several weeks postpartum.&#xD;
  &#xD;
        When women finish their 6 weeks of puerperium, it may be suspected to return in the pelvic&#xD;
        tilting angle to its measurements prior to gestation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 28, 2021</start_date>
    <completion_date type="Actual">February 15, 2022</completion_date>
    <primary_completion_date type="Actual">January 29, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>pelvic tilt angle</measure>
      <time_frame>6-12 weeks after Cesarean delivery</time_frame>
      <description>angle between the line passing from the posterior and anterior superior iliac spines, and the horizontal plane</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>pelvic torsion</measure>
      <time_frame>6-12 weeks after Cesarean delivery</time_frame>
      <description>the calculated numerical degrees when the angle of pelvic tilt on the right side is substracted from its counterpart on the left side</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">40</enrollment>
    <condition>Pelvic Obliquity</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <description>20 postpartum women who delivered by cesarean section</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <description>20 females who did not experience pregnancy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>digital pelvic inclinometer</intervention_name>
      <description>It is a reliable and valid instrument for measuring pelvic tilt angle</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          40 subjects participated in this study aged between 18 and 34 years old. They were&#xD;
          recruited from South Valley University Hospitals and classified into 2 groups equal in&#xD;
          their numbers.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women who underwent cesarean delivery&#xD;
  &#xD;
            -  Women who were classified as having normal or overweight score on body mass index&#xD;
  &#xD;
            -  Women in their 6-12 weeks postpartum&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who underwent vaginal delivery&#xD;
  &#xD;
            -  Women who were obese on the body mass index&#xD;
  &#xD;
            -  Women with postpartum duration of less than 6 weeks or more than 12 weeks&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>a study in the field of obstetric physiotherapy</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>34 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of physical therapy, South Valley University</name>
        <address>
          <city>Qinā</city>
          <state>Qena</state>
          <zip>83523</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.</citation>
      <PMID>9742469</PMID>
    </reference>
    <reference>
      <citation>Chauhan G, Tadi P. Physiology, Postpartum Changes. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555904/</citation>
      <PMID>32310364</PMID>
    </reference>
    <results_reference>
      <citation>Liddle SD, Pennick V. Interventions for preventing and treating low-back and pelvic pain during pregnancy. Cochrane Database Syst Rev. 2015 Sep 30;2015(9):CD001139. doi: 10.1002/14651858.CD001139.pub4.</citation>
      <PMID>26422811</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>South Valley University</investigator_affiliation>
      <investigator_full_name>Mohamed Gamal Abouelyazeed Ali</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy for Women's Health</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019962
  org study id: Pelvic Tilting
  nct id: NCT06019962
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The slight anterior pelvic tilt is a physiological posture in healthy males and females,
        however, excessive anterior pelvic tilt is associated with different lumbopelvic discomfort
        either during gestation or after childbirth.
  As pregnant women move from the 1st to the 3rd trimester, they exhibit a notable increase in
        the angle of pelvic tilting. This may explain the painful pelvic girdle syndrome during
        gestation which can last for several weeks postpartum.
  
        When women finish their 6 weeks of puerperium, it may be suspected to return in the pelvic
        tilting angle to its measurements prior to gestation.
  observational model: Cohort
  time perspective: Retrospective
  measure: pelvic tilt angle
  time frame: 6-12 weeks after Cesarean delivery
  description: angle between the line passing from the posterior and anterior superior iliac spines, and the horizontal plane
  measure: pelvic torsion
  time frame: 6-12 weeks after Cesarean delivery
  description: the calculated numerical degrees when the angle of pelvic tilt on the right side is substracted from its counterpart on the left side
  arm group label: Group A
  description: 20 postpartum women who delivered by cesarean section
  arm group label: Group B
  description: 20 females who did not experience pregnancy
  intervention type: Device
  intervention name: digital pelvic inclinometer
  description: It is a reliable and valid instrument for measuring pelvic tilt angle
  arm group label: Group A
  arm group label: Group B
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: a study in the field of obstetric physiotherapy
  minimum age: 18 Years
  maximum age: 34 Years
  facility: 
  country: Egypt
  citation: Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.
  PMID: 9742469
  citation: Chauhan G, Tadi P. Physiology, Postpartum Changes. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555904/
  PMID: 32310364
  citation: Liddle SD, Pennick V. Interventions for preventing and treating low-back and pelvic pain during pregnancy. Cochrane Database Syst Rev. 2015 Sep 30;2015(9):CD001139. doi: 10.1002/14651858.CD001139.pub4.
  PMID: 26422811
  responsible party type: Principal Investigator
  investigator affiliation: South Valley University
  investigator full name: Mohamed Gamal Abouelyazeed Ali
  investigator title: Lecturer of Physical Therapy for Women's Health