<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/NCT02265081</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1162-7720</org_study_id>
    <nct_id>NCT02265081</nct_id>
  </id_info>
  <brief_title>A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome</brief_title>
  <acronym>PLUSSMODEL</acronym>
  <official_title>A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham Women's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Birmingham Women's NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is to evaluate if there are specific factors in the pelvic floor&#xD;
      functional anatomy which can predict the ability of having a vaginal birth after caesarean&#xD;
      section.&#xD;
&#xD;
      Physical characteristics of the soft tissue in the female pelvis play an important role in&#xD;
      successful vaginal delivery. A &quot;tight&quot; or less distensible pelvic floor muscles may influence&#xD;
      mode of delivery, leading to poor labour progression and by compressing foetal head produce&#xD;
      CTG abnormality such as decelerations, both resulting in caesarean delivery.&#xD;
&#xD;
      One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the&#xD;
      passage of fetal head through the birth canal by stretching and distending. Therefore&#xD;
      distensibility of the female pelvic floor influences mode of delivery.&#xD;
&#xD;
      Three hundred patients, in the third trimester of pregnancy, will be recruited via the&#xD;
      antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible&#xD;
      participants are pregnant women who had either one or no vaginal births, or one caesarean&#xD;
      section and who can give an informed consent and maintain their autonomy regarding mode of&#xD;
      delivery with understanding of the forthcoming study results. Participants will be excluded&#xD;
      if they sustain any obstetric complications that may impede on time and mode of delivery&#xD;
      including an emergency prelabour caesarean section.&#xD;
&#xD;
      Ultrasonographic assessment of the differences in the pelvic characteristics of these women&#xD;
      will be used to predict a successful of trial of vaginal delivery after caesarean section&#xD;
      (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is&#xD;
      a simple (single ultrasound assessment) that can be used to help inform women's choice&#xD;
      regarding mode of delivery.&#xD;
&#xD;
      Results from this research could be a pioneering blueprint for further studies, as there is&#xD;
      very little known about this topic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>vaginal delivery</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>voiding problems</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Pelvic Floor Disorders</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>nulliparous women</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester</description>
  </arm_group>
  <arm_group>
    <arm_group_label>parous women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester</description>
  </arm_group>
  <arm_group>
    <arm_group_label>parous women - VBAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>pelvic floor ultrasound</description>
    <arm_group_label>nulliparous women</arm_group_label>
    <arm_group_label>parous women</arm_group_label>
    <arm_group_label>parous women - VBAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>uroflow-meter</intervention_name>
    <description>uroflow meter: measurement of passed urine volume</description>
    <arm_group_label>nulliparous women</arm_group_label>
    <arm_group_label>parous women</arm_group_label>
    <arm_group_label>parous women - VBAC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. English speaking women&#xD;
&#xD;
          2. over 16 years old women&#xD;
&#xD;
          3. women willing to provide written informed consent&#xD;
&#xD;
          4. women who had either prior vaginal delivery or caesarean section or no prior birth&#xD;
             experience&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who cannot give an informed consent,&#xD;
&#xD;
          2. under the age of consent,&#xD;
&#xD;
          3. any participants whose pregnancies complicated during the antenatal period that may&#xD;
             influence decision on time and mode of delivery that is anyone who has to undergo an&#xD;
             emergency prelabour LSCS,&#xD;
&#xD;
          4. nonEnglish speaking women&#xD;
&#xD;
          5. less than 16 years old women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly Hard</last_name>
    <role>Study Chair</role>
    <affiliation>R&amp;D Dept, Birmingham Women's Hospital, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Women's Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B29 6SN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>July 26, 2015</last_update_submitted>
  <last_update_submitted_qc>July 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Birmingham Women's NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Aneta Obloza</investigator_full_name>
    <investigator_title>DR ANETA OBLOZA</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Floor 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/NCT02265081
org study id: U1111-1162-7720
nct id: NCT02265081
lead sponsor: 
has dmc: No
The proposed study is to evaluate if there are specific factors in the pelvic floor
      functional anatomy which can predict the ability of having a vaginal birth after caesarean
      section.

      Physical characteristics of the soft tissue in the female pelvis play an important role in
      successful vaginal delivery. A "tight" or less distensible pelvic floor muscles may influence
      mode of delivery, leading to poor labour progression and by compressing foetal head produce
      CTG abnormality such as decelerations, both resulting in caesarean delivery.

      One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the
      passage of fetal head through the birth canal by stretching and distending. Therefore
      distensibility of the female pelvic floor influences mode of delivery.

      Three hundred patients, in the third trimester of pregnancy, will be recruited via the
      antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible
      participants are pregnant women who had either one or no vaginal births, or one caesarean
      section and who can give an informed consent and maintain their autonomy regarding mode of
      delivery with understanding of the forthcoming study results. Participants will be excluded
      if they sustain any obstetric complications that may impede on time and mode of delivery
      including an emergency prelabour caesarean section.

      Ultrasonographic assessment of the differences in the pelvic characteristics of these women
      will be used to predict a successful of trial of vaginal delivery after caesarean section
      (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is
      a simple (single ultrasound assessment) that can be used to help inform women's choice
      regarding mode of delivery.

      Results from this research could be a pioneering blueprint for further studies, as there is
      very little known about this topic.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: vaginal delivery
time frame: 12 months
measure: voiding problems
time frame: 12 months
arm group label: nulliparous women
arm group type: Active Comparator
description: internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
arm group label: parous women
arm group type: Experimental
description: those who had vaginal delivery in the past; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
arm group label: parous women - VBAC
arm group type: Experimental
description: those with previous LSCS and no vaginal births; internal ultrasound in the 3rd trimester uroflow meter in 3rd trimester
intervention type: Procedure
intervention name: ultrasound
description: pelvic floor ultrasound
arm group label: nulliparous women
arm group label: parous women
arm group label: parous women - VBAC
intervention type: Procedure
intervention name: uroflow-meter
description: uroflow meter: measurement of passed urine volume
arm group label: nulliparous women
arm group label: parous women
arm group label: parous women - VBAC
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kelly Hard
role: Study Chair
affiliation: R&D Dept, Birmingham Women's Hospital, UK
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Birmingham Women's NHS Foundation Trust
investigator full name: Aneta Obloza
investigator title: DR ANETA OBLOZA
mesh term: Pelvic Floor Disorders