<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/NCT03257514</url>
  </required_header>
  <id_info>
    <org_study_id>maternity hospital ASU</org_study_id>
    <nct_id>NCT03257514</nct_id>
  </id_info>
  <brief_title>Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section</brief_title>
  <official_title>Assessing The Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section by Using Saline Contrast Sonohysterography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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 aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar&#xD;
      healing after cesarean section by using saline contrast sonohysterography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a triple blind randomized placebo controlled prospective clinical trial that will be&#xD;
      conducted in Ain Shams University Maternity Hospital.&#xD;
&#xD;
      in which a consecutive series of participant attending emergency room 102 women undergoing&#xD;
      cesarean section for the first time will be randomized into two groups.&#xD;
&#xD;
      Group A (Study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for&#xD;
      6 weeks after cesarean section and saline sonohysterography will be done after that.&#xD;
&#xD;
      Group B (Control group): 51 women will receive a placebo drug twice daily for 6 weeks after&#xD;
      cesarean section and saline sonohysterography will be done after that.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>presence of scar niche</measure>
    <time_frame>six weeks after CS</time_frame>
    <description>triangular shaped anechoic area at the site of incision</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The healing ratio</measure>
    <time_frame>six weeks after CS</time_frame>
    <description>the thickness of residual myometrium covering the defect divided by the sum of the thickness of residual myometrium cover the defect and the height of wedge shaped defect</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Cesarean Section; Dehiscence</condition>
  <condition>Cesarean Scar Niche</condition>
  <arm_group>
    <arm_group_label>alpha lipoic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>51 women will receive alpha lipoic acid drug (thiotacid film coated tablets 600 mg) for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography (by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>51 women will receive a placebo drug for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography(by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alpha lipoic acid drug (thioctic acid acid)</intervention_name>
    <description>Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.</description>
    <arm_group_label>alpha lipoic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>placebo oral drug have the same shape of thiotacid tablet</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Term pregnancy (gestational age between 37-41 weeks).&#xD;
&#xD;
          -  Women undergoing cesarean section for the first time.&#xD;
&#xD;
          -  Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.&#xD;
&#xD;
          -  Uncomplicated cesarean section.&#xD;
&#xD;
          -  Lower uterine segment cesarean sections while the women not in labor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with complications during or after cesarean section as intrapartum or postpartum&#xD;
             hemorrhage, puerperal sepsis, septic wound&#xD;
&#xD;
          -  Women with medical diseases that can affect the healing as diabetes mellitus, anemia,&#xD;
             chronic renal disease or hepatic disease or coagulopathy or receiving medications&#xD;
             affect wound healing as corticosteroids or anticoagulant.&#xD;
&#xD;
          -  Women who will use intrauterine device as a contraceptive method&#xD;
&#xD;
          -  Women with uterine abnormality as cervical stenosis or fibroid uterus&#xD;
&#xD;
          -  Women with pelvic infection at the time of saline sonohysterography&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbassia</state>
        <zip>02002</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Rasheedy Ali</investigator_full_name>
    <investigator_title>lecturer</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thioctic Acid</mesh_term>
  </intervention_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/NCT03257514
org study id: maternity hospital ASU
nct id: NCT03257514
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar
      healing after cesarean section by using saline contrast sonohysterography
This is a triple blind randomized placebo controlled prospective clinical trial that will be
      conducted in Ain Shams University Maternity Hospital.

      in which a consecutive series of participant attending emergency room 102 women undergoing
      cesarean section for the first time will be randomized into two groups.

      Group A (Study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for
      6 weeks after cesarean section and saline sonohysterography will be done after that.

      Group B (Control group): 51 women will receive a placebo drug twice daily for 6 weeks after
      cesarean section and saline sonohysterography will be done after that.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: presence of scar niche
time frame: six weeks after CS
description: triangular shaped anechoic area at the site of incision
measure: The healing ratio
time frame: six weeks after CS
description: the thickness of residual myometrium covering the defect divided by the sum of the thickness of residual myometrium cover the defect and the height of wedge shaped defect
arm group label: alpha lipoic acid
arm group type: Active Comparator
description: 51 women will receive alpha lipoic acid drug (thiotacid film coated tablets 600 mg) for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography (by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)
arm group label: placebo
arm group type: Placebo Comparator
description: 51 women will receive a placebo drug for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography(by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view)
intervention type: Drug
intervention name: alpha lipoic acid drug (thioctic acid acid)
description: Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.
arm group label: alpha lipoic acid
intervention type: Drug
intervention name: Placebo Oral Tablet
description: placebo oral drug have the same shape of thiotacid tablet
arm group label: placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Rasheedy Ali
investigator title: lecturer
mesh term: Thioctic Acid