<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/NCT03835650</url>
  </required_header>
  <id_info>
    <org_study_id>PN/19/2019</org_study_id>
    <nct_id>NCT03835650</nct_id>
  </id_info>
  <brief_title>Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors</brief_title>
  <official_title>Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Żelazna Medical Centre, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre of Postgraduate Medical Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Żelazna Medical Centre, LLC</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly&#xD;
      after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the&#xD;
      posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac&#xD;
      joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction&#xD;
      with/or separately in the symphysis. The endurance capacity for standing, walking, and&#xD;
      sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes.&#xD;
      The pain or functional disturbances in relation to PGP must be reproducible by specific&#xD;
      clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may&#xD;
      contribute to development of chronic condition, lowering quality of life years after&#xD;
      delivery.&#xD;
&#xD;
      Objectives: The aim of the project is to evaluate the underlying cause of the severe pelvic&#xD;
      girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess&#xD;
      the differences between females with severe postpartum PGP, mild and moderate PGP and with no&#xD;
      PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea&#xD;
      alba dysfunction, factors associated with labour and maladaptive mental processing&#xD;
      (catastrophizing).&#xD;
&#xD;
      Materials and methods: Because of low incidence of researched conditions, a case control&#xD;
      study will be the study design of choice. The subjects with PGP will be matched with those&#xD;
      with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of&#xD;
      diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis&#xD;
      (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing&#xD;
      Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to&#xD;
      full dilatation and delivery) will be also investigated.&#xD;
&#xD;
      Expected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been&#xD;
      extensively studied so far. The study will bring information about the possible underlying&#xD;
      cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">February 25, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</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>Diastasis Recti: ultrasound measurement of inter-recti distance</measure>
    <time_frame>one time assessment, during the hospital stay, within 1st week postpartum</time_frame>
    <description>measurement of inter-recti distance (ultrasound assessment at the level of umbilicus, 2cm over the umbilicus and 2 cm below)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pubic symphysis distance</measure>
    <time_frame>one time assessment, during the hospital stay, within 1st week postpartum</time_frame>
    <description>assesment of pubic symphysis distance - presence of diastasis pubic symphysis, distance measured by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale</measure>
    <time_frame>one time assessment, during the hospital stay, within 1st week postpartum</time_frame>
    <description>Assesment of Catastrophizing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epidural anaesthesia</measure>
    <time_frame>during labour (Time form injection to full cervical dilatation)</time_frame>
    <description>Time form injection to full cervical dilatation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epidural anaesthaesia2</measure>
    <time_frame>during labour (Time form injection to labour)</time_frame>
    <description>Time form injection to labour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastasis Recti: inter-recti distance</measure>
    <time_frame>one time assessment, during the hospital stay, within 1st week postpartum</time_frame>
    <description>measurement of inter-recti distance by palpation examination at the level of umbilicus, 2cm over the umbilicus and 2 cm below</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Pelvic Girdle Pain</condition>
  <condition>Pubic Symphysis Diastasis</condition>
  <condition>Diastasis Recti</condition>
  <arm_group>
    <arm_group_label>PGP</arm_group_label>
    <description>Patients in early postpartum period experiencing PGP, confirmed with dedicated functional tests</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no PGP</arm_group_label>
    <description>Patients in early postpartum period, with no symptoms and signs of PGP</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women in early postpartum period (during hospital stay)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Natural labour or vacuum extractor or forceps&#xD;
&#xD;
          -  for the study group - pain due to PGP confirmed with dedicated functional tests&#xD;
&#xD;
          -  for control group with no pain - no pain due to PGP&#xD;
&#xD;
          -  agreement to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis,&#xD;
             Ehler's-Danlos Syndrome, hip dysplasia&#xD;
&#xD;
          -  major peri-partum events like internal haemorrhage, pelvic fracture&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre of Postgraduate Medical Education</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>01-004</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pubic Symphysis Diastasis</mesh_term>
    <mesh_term>Pelvic Girdle Pain</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/NCT03835650
org study id: PN/19/2019
nct id: NCT03835650
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly
      after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the
      posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac
      joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction
      with/or separately in the symphysis. The endurance capacity for standing, walking, and
      sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes.
      The pain or functional disturbances in relation to PGP must be reproducible by specific
      clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may
      contribute to development of chronic condition, lowering quality of life years after
      delivery.

      Objectives: The aim of the project is to evaluate the underlying cause of the severe pelvic
      girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess
      the differences between females with severe postpartum PGP, mild and moderate PGP and with no
      PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea
      alba dysfunction, factors associated with labour and maladaptive mental processing
      (catastrophizing).

      Materials and methods: Because of low incidence of researched conditions, a case control
      study will be the study design of choice. The subjects with PGP will be matched with those
      with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of
      diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis
      (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing
      Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to
      full dilatation and delivery) will be also investigated.

      Expected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been
      extensively studied so far. The study will bring information about the possible underlying
      cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis.
observational model: Cohort
time perspective: Prospective
measure: Diastasis Recti: ultrasound measurement of inter-recti distance
time frame: one time assessment, during the hospital stay, within 1st week postpartum
description: measurement of inter-recti distance (ultrasound assessment at the level of umbilicus, 2cm over the umbilicus and 2 cm below)
measure: Pubic symphysis distance
time frame: one time assessment, during the hospital stay, within 1st week postpartum
description: assesment of pubic symphysis distance - presence of diastasis pubic symphysis, distance measured by ultrasound
measure: Pain Catastrophizing Scale
time frame: one time assessment, during the hospital stay, within 1st week postpartum
description: Assesment of Catastrophizing
measure: Epidural anaesthesia
time frame: during labour (Time form injection to full cervical dilatation)
description: Time form injection to full cervical dilatation
measure: Epidural anaesthaesia2
time frame: during labour (Time form injection to labour)
description: Time form injection to labour
measure: Diastasis Recti: inter-recti distance
time frame: one time assessment, during the hospital stay, within 1st week postpartum
description: measurement of inter-recti distance by palpation examination at the level of umbilicus, 2cm over the umbilicus and 2 cm below
arm group label: PGP
description: Patients in early postpartum period experiencing PGP, confirmed with dedicated functional tests
arm group label: no PGP
description: Patients in early postpartum period, with no symptoms and signs of PGP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Pubic Symphysis Diastasis
mesh term: Pelvic Girdle Pain