<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/NCT02248376</url>
  </required_header>
  <id_info>
    <org_study_id>P 130911</org_study_id>
    <secondary_id>AOR13019</secondary_id>
    <nct_id>NCT02248376</nct_id>
  </id_info>
  <brief_title>Hyaluronic Acid and Uterine Synechiae</brief_title>
  <acronym>HYFACO</acronym>
  <official_title>Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of the study is to compare efficiency of a non-stick gel application&#xD;
      after scraping surgery for natural miscarriage with no non-stick gel application after&#xD;
      scraping surgery.&#xD;
&#xD;
      Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8&#xD;
      weeks after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women patients coming for natural miscarriage will be compared according to whether a&#xD;
      non-stick gel will be applicated or not after scraping surgery.&#xD;
&#xD;
      6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical&#xD;
      hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study&#xD;
      without knowing the randomization arm.&#xD;
&#xD;
      Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick&#xD;
      gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery&#xD;
      using questionnaire asked by post, mail or phone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2014</start_date>
  <completion_date type="Actual">September 14, 2018</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.</measure>
    <time_frame>6-8 weeks after scraping surgery</time_frame>
    <description>Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery.</measure>
    <time_frame>6, 12 and 24 months after scraping surgery</time_frame>
    <description>Evaluation using questionnaires asked by post, mail or phone at 6, 12, and 24 months after scraping surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.</measure>
    <time_frame>Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.</time_frame>
    <description>Evaluation using questionnaires asked by post, mail or phone at 12 and 24 months after scraping surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of post-surgical synechiae stretch and severity</measure>
    <time_frame>6-8 weeks after scraping surgery</time_frame>
    <description>Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study</measure>
    <time_frame>36 months</time_frame>
    <description>Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Uterine Synechiae After Scraping for Natural Miscarriage</condition>
  <arm_group>
    <arm_group_label>Gel +</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gel -</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients aged of more than 18 years-old coming for a natural miscarriage who will not have the non-stick gel application at the end of the scraping surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gel</intervention_name>
    <description>Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.</description>
    <arm_group_label>Gel +</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women patients aged between 18 and 46 years old&#xD;
&#xD;
          -  Term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea&#xD;
&#xD;
          -  Blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention&#xD;
             miscarriage&#xD;
&#xD;
          -  Consent signature&#xD;
&#xD;
          -  Social security coverage&#xD;
&#xD;
          -  Women who wants to be pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infected miscarriage&#xD;
&#xD;
          -  Uncertain diagnosis between miscarriage and extra-uterine pregnancy&#xD;
&#xD;
          -  Hydatiform mole&#xD;
&#xD;
          -  Uterine synechiae history&#xD;
&#xD;
          -  Surgical zone infection&#xD;
&#xD;
          -  Hyalobarrier® gel Endo hypersensitivity&#xD;
&#xD;
          -  Clotting disorder&#xD;
&#xD;
          -  Unstable diabetes&#xD;
&#xD;
          -  Maternal malignant diseases&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  Incapacity in understanding the consent form and the questionnaires&#xD;
&#xD;
          -  Law protected adult person&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Louis Benifla, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Lariboisière - Service de Gynécologie-Obstétrique</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Uterine synechiae Scraping surgery Natural miscarriage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Gynatresia</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/NCT02248376
org study id: P 130911
secondary id: AOR13019
nct id: NCT02248376
lead sponsor: 
has dmc: No
The primary purpose of the study is to compare efficiency of a non-stick gel application
      after scraping surgery for natural miscarriage with no non-stick gel application after
      scraping surgery.

      Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8
      weeks after surgery.
Women patients coming for natural miscarriage will be compared according to whether a
      non-stick gel will be applicated or not after scraping surgery.

      6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical
      hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study
      without knowing the randomization arm.

      Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick
      gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery
      using questionnaire asked by post, mail or phone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
time frame: 6-8 weeks after scraping surgery
description: Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.
measure: Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery.
time frame: 6, 12 and 24 months after scraping surgery
description: Evaluation using questionnaires asked by post, mail or phone at 6, 12, and 24 months after scraping surgery.
measure: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
time frame: Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.
description: Evaluation using questionnaires asked by post, mail or phone at 12 and 24 months after scraping surgery.
measure: Evaluation of post-surgical synechiae stretch and severity
time frame: 6-8 weeks after scraping surgery
description: Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
measure: Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study
time frame: 36 months
description: Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
arm group label: Gel +
arm group type: Experimental
description: Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.
arm group label: Gel -
arm group type: No Intervention
description: Patients aged of more than 18 years-old coming for a natural miscarriage who will not have the non-stick gel application at the end of the scraping surgery.
intervention type: Drug
intervention name: Gel
description: Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.
arm group label: Gel +
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
last name: Jean-Louis Benifla, MD-PhD
role: Principal Investigator
affiliation: Assistance Publique
facility: 
country: France
responsible party type: Sponsor
mesh term: Abortion, Spontaneous
mesh term: Gynatresia