<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/NCT03752879</url>
  </required_header>
  <id_info>
    <org_study_id>BezmialemVU Fundal Pressure</org_study_id>
    <nct_id>NCT03752879</nct_id>
  </id_info>
  <brief_title>The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery</brief_title>
  <official_title>The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif 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>
      We want to investigate the association between fundal pressure in the second stage and the&#xD;
      risk of levator ani muscle (LAM) injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will recruit women immediately following their first vaginal delivery. Women who underwent&#xD;
      Kristeller maneuver will be recruit as cases. For each case, a control (no fundal pressure)&#xD;
      will be recruit matched by BMI, second stage duration and birthweight. All women will be&#xD;
      invited to undergo a postpartum 3D transperineal ultrasound (TPUS). The main outcome measure&#xD;
      will be the presence of LAM avulsion at 3D TPUS. TPUS results will be compared between cases&#xD;
      and controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2019</start_date>
  <completion_date type="Actual">October 18, 2019</completion_date>
  <primary_completion_date type="Actual">July 18, 2019</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>levator ani muscle (LAM) injury</measure>
    <time_frame>24 hour</time_frame>
    <description>The aim of the study is to investigate levator ani muscle (LAM) injury, loss of tenting, biometric measurements of LAM and genital hiatus after vaginal delivery and investigate the association between fundal pressure in the second stage of labor (Kristeller maneuver).&#xD;
All recruited women will be invited to undergo a transperineal 3D ultrasound (TPUS) scan at 24 hours after delivery. we will acquire two 3D volumes for each patient: one under maximum pelvic floor muscle contraction (PFMC) and the other under maximum Valsalva's maneuver. Ballooning&quot; will diagnosed with a pelvic hiatal area of more than 25 cm2 during maximum Valsalva. A complete avulsion of the puborectalis muscle will diagnose if an abnormal insertion of the muscle will be detected on all three central slices. We will use a levator-urethral gap more than 2.5 cm to define an abnormal insertion.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">86</enrollment>
  <condition>Labor Complication</condition>
  <condition>Avulsion</condition>
  <arm_group>
    <arm_group_label>Case (Kristaller Group)</arm_group_label>
    <description>Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (no Kristaller Group)</arm_group_label>
    <description>The control group not required to kristeller maneuver</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fundal Pressure</intervention_name>
    <description>Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor</description>
    <arm_group_label>Case (Kristaller Group)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First delivery&#xD;
&#xD;
          -  Term pregnancy (37-41w)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Instrumental vaginal delivery&#xD;
&#xD;
          -  Multifetal pregnancy&#xD;
&#xD;
          -  Previous vaginal or cesarean delivery&#xD;
&#xD;
          -  Refused consent and uncooperative patient for effective Valsalva maneuver&#xD;
&#xD;
          -  Handicap in lithotomy position&#xD;
&#xD;
          -  Women without regular and active contractions&#xD;
&#xD;
          -  Epidural analgesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>biological female gender</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bezmialem Vakıf University Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kristeller maneuver,LAM avulsion,3D transperineal ultrasoun</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor Complications</mesh_term>
    <mesh_term>Fractures, Avulsion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03752879
org study id: BezmialemVU Fundal Pressure
nct id: NCT03752879
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We want to investigate the association between fundal pressure in the second stage and the
      risk of levator ani muscle (LAM) injury.
We will recruit women immediately following their first vaginal delivery. Women who underwent
      Kristeller maneuver will be recruit as cases. For each case, a control (no fundal pressure)
      will be recruit matched by BMI, second stage duration and birthweight. All women will be
      invited to undergo a postpartum 3D transperineal ultrasound (TPUS). The main outcome measure
      will be the presence of LAM avulsion at 3D TPUS. TPUS results will be compared between cases
      and controls.
observational model: Case-Control
time perspective: Prospective
measure: levator ani muscle (LAM) injury
time frame: 24 hour
description: The aim of the study is to investigate levator ani muscle (LAM) injury, loss of tenting, biometric measurements of LAM and genital hiatus after vaginal delivery and investigate the association between fundal pressure in the second stage of labor (Kristeller maneuver).
All recruited women will be invited to undergo a transperineal 3D ultrasound (TPUS) scan at 24 hours after delivery. we will acquire two 3D volumes for each patient: one under maximum pelvic floor muscle contraction (PFMC) and the other under maximum Valsalva's maneuver. Ballooning" will diagnosed with a pelvic hiatal area of more than 25 cm2 during maximum Valsalva. A complete avulsion of the puborectalis muscle will diagnose if an abnormal insertion of the muscle will be detected on all three central slices. We will use a levator-urethral gap more than 2.5 cm to define an abnormal insertion.
arm group label: Case (Kristaller Group)
description: Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.
arm group label: Control (no Kristaller Group)
description: The control group not required to kristeller maneuver
intervention type: Procedure
intervention name: Fundal Pressure
description: Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor
arm group label: Case (Kristaller Group)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: biological female gender
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Obstetric Labor Complications
mesh term: Fractures, Avulsion
sharing ipd: No