<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/NCT03812406</url>
  </required_header>
  <id_info>
    <org_study_id>FAUCS</org_study_id>
    <nct_id>NCT03812406</nct_id>
  </id_info>
  <brief_title>Comparison of FAUCS vs. Misgav Ladach</brief_title>
  <official_title>Comparison Between French Ambulatory Cesarean Section to The Misgav-Ladach Technique - Double Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bnai Zion Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bnai Zion Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach&#xD;
      versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to&#xD;
      reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such&#xD;
      comparison has not been done so far, and this study will examined if indeed the FAUCS&#xD;
      techniques offers any advantages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FAUCS technique for performing a cesarean section has been described by a French group&#xD;
      several years ago, and is claimed to reduce postoperative pain and increase ambulation. With&#xD;
      this technique, after making the transverse skin incision, the fascia is opened vertically&#xD;
      and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally,&#xD;
      and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the&#xD;
      reduced incision size, a special spatula is used to facilitate extraction of the fetal head&#xD;
      in some cases. No urinary catheter is used during or after the operation, and fluid&#xD;
      administration is restricted during the procedure. The patient is encouraged to get out of&#xD;
      bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared&#xD;
      with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for&#xD;
      analgesics, ambulation, neonatal outcome, and perioperative complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 19, 2018</start_date>
  <completion_date type="Anticipated">September 19, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 19, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite maternal adverse outcome</measure>
    <time_frame>24 hours post surgery</time_frame>
    <description>The rate of women with a composite maternal adverse outcome, defined as at least one of the following: Visual Analogue Scale score &gt;6 (scale of 1-10, 1 being a very mild pain, 10 being the worst pain imagineable) at 3-4 hours post surgery, inability to ambulate 3-4 hours post surgery, and QoR15 (Quality of Recovery) score &lt; 90 (range 0 to 150, 150 being the best recovery after surgery) at 24 hours post surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>The duration of surgery (in minutes) from incision until closure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss (ml) during surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>The estimated volume of blood (in ml) lost during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birthweight</measure>
    <time_frame>immediately after birth</time_frame>
    <description>The weight (grams) of the neonate immediately after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord pH</measure>
    <time_frame>immediately after birth</time_frame>
    <description>The pH measured in a blood sample from the umbilical artery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth trauma</measure>
    <time_frame>24 hours</time_frame>
    <description>The rate of birthtrauma in diagnosed in the neonate (shoulder dystocia, fracture, cerebral hemorrhage, cephalhematoma, etc.)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Ambulation Difficulty</condition>
  <arm_group>
    <arm_group_label>FAUCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing a cesarean section using the FAUCS technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>French Abulatory Cesrean Section</intervention_name>
    <description>A cesarean section performed according to the FAUCS technique</description>
    <arm_group_label>FAUCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Misgav-Ladach</intervention_name>
    <description>A cesarean section performed according to the Misgav Ladach technique</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for a cesarean section&#xD;
&#xD;
          -  term pregnancy: 37-42 weeks&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  age 18 and above&#xD;
&#xD;
          -  patients capable of signing an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  emergency cesarean&#xD;
&#xD;
          -  previous 3 cesareans and above&#xD;
&#xD;
          -  placenta accreta&#xD;
&#xD;
          -  uterine myomas in the lower segment&#xD;
&#xD;
          -  fetal growth restriction&#xD;
&#xD;
          -  fetal anemia&#xD;
&#xD;
          -  preeclampsia&#xD;
&#xD;
          -  women scheduled for general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rami Sammour, MD</last_name>
    <phone>+972506267390</phone>
    <email>rsammour2002@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bnai-Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rami Sammour</last_name>
      <phone>0506267390</phone>
    </contact>
    <investigator>
      <last_name>Shlomi Sagie, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rami Sammour, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Israel Hendler, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cesarean</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Mobility Limitation</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/NCT03812406
org study id: FAUCS
nct id: NCT03812406
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach
      versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to
      reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such
      comparison has not been done so far, and this study will examined if indeed the FAUCS
      techniques offers any advantages.
The FAUCS technique for performing a cesarean section has been described by a French group
      several years ago, and is claimed to reduce postoperative pain and increase ambulation. With
      this technique, after making the transverse skin incision, the fascia is opened vertically
      and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally,
      and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the
      reduced incision size, a special spatula is used to facilitate extraction of the fetal head
      in some cases. No urinary catheter is used during or after the operation, and fluid
      administration is restricted during the procedure. The patient is encouraged to get out of
      bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared
      with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for
      analgesics, ambulation, neonatal outcome, and perioperative complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Composite maternal adverse outcome
time frame: 24 hours post surgery
description: The rate of women with a composite maternal adverse outcome, defined as at least one of the following: Visual Analogue Scale score >6 (scale of 1-10, 1 being a very mild pain, 10 being the worst pain imagineable) at 3-4 hours post surgery, inability to ambulate 3-4 hours post surgery, and QoR15 (Quality of Recovery) score < 90 (range 0 to 150, 150 being the best recovery after surgery) at 24 hours post surgery
measure: Length of surgery
time frame: 24 hours
description: The duration of surgery (in minutes) from incision until closure.
measure: Blood loss (ml) during surgery
time frame: 24 hours
description: The estimated volume of blood (in ml) lost during surgery
measure: Birthweight
time frame: immediately after birth
description: The weight (grams) of the neonate immediately after birth
measure: Cord pH
time frame: immediately after birth
description: The pH measured in a blood sample from the umbilical artery
measure: Birth trauma
time frame: 24 hours
description: The rate of birthtrauma in diagnosed in the neonate (shoulder dystocia, fracture, cerebral hemorrhage, cephalhematoma, etc.)
arm group label: FAUCS
arm group type: Experimental
description: Patients undergoing a cesarean section using the FAUCS technique
arm group label: Control
arm group type: Active Comparator
description: Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique
intervention type: Procedure
intervention name: French Abulatory Cesrean Section
description: A cesarean section performed according to the FAUCS technique
arm group label: FAUCS
intervention type: Procedure
intervention name: Misgav-Ladach
description: A cesarean section performed according to the Misgav Ladach technique
arm group label: Control
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rami Sammour, MD
phone: +972506267390
email: rsammour2002@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Mobility Limitation