<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/NCT02201732</url>
  </required_header>
  <id_info>
    <org_study_id>P130920</org_study_id>
    <secondary_id>2014-A00340-47</secondary_id>
    <nct_id>NCT02201732</nct_id>
  </id_info>
  <brief_title>Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions</brief_title>
  <acronym>HY-PER</acronym>
  <official_title>Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions</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 purpose of this study of is to compare subsequent fertility rates between hysteroscopy&#xD;
      and aspirative curettage in the surgical treatment of incomplete spontaneous abortion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Incomplete spontaneous abortion (ISA) is defined by the intrauterine retention of conceptual&#xD;
      product after incomplete or partial expulsion of the conceptual product. Treatment such&#xD;
      retention may be expectant care, medical treatment or surgery. Currently, curettage is the&#xD;
      standard surgical treatment in most centers. However, operative hysteroscopy, in addition to&#xD;
      the direct visualization of the retained conceptual product, in contrast to the curettage,&#xD;
      would allow elective evacuation of retention while reducing surgical complications. Studies&#xD;
      of low effective, retrospective, have found an fertility's increase in patients treated by&#xD;
      operative hysteroscopy. These data need to be confirmed by a randomized controlled trial in&#xD;
      order to change the standard surgical treatment of this disease if hysteroscopy procedure&#xD;
      would found to be superior.&#xD;
&#xD;
      We propose a multicenter - single blind - randomized - therapeutic study. Randomization will&#xD;
      concern the surgical procedure in patients treated surgically for intrauterine retention&#xD;
      after spontaneous miscarriage. Randomization will be performed at the admission to the&#xD;
      patient in the operating room by electronic means using a secure internet platform,&#xD;
      single-blind for the patient with unblinding at the end of the trial or in case of&#xD;
      complication. The patient will be randomly assigned to one of two treatment arms following:&#xD;
&#xD;
        -  Arm A : Operative hysteroscopy&#xD;
&#xD;
        -  Arm B : Aspirative curettage The inclusion will be performed at time of diagnosis&#xD;
           (incomplete miscarriage) with an ultrasound of intrauterine retention for which surgical&#xD;
           treatment has been decided. The initial medical examination (inclusion visit) will&#xD;
           include a complete gynecological examination. The diagnosis of incomplete miscarriage&#xD;
           will be performed using a transvaginal pelvic ultrasound. Transvaginal ultrasound will&#xD;
           be performed according to a technique of standardized pelvic ultrasound ; the retention&#xD;
           will be diagnosed in the presence of a heterogeneous image or intrauterine gestational&#xD;
           sac more than 15 mm in thickness. On this visit, the patient will complete a&#xD;
           questionnaire concerning her medical histories and the aborted pregnancy.&#xD;
&#xD;
      Patients will have a care in accordance with center practices for the hospital stay. Surgical&#xD;
      treatment will be performed within the time depending on the availability of the operating&#xD;
      room of participating center.&#xD;
&#xD;
      A hospitalization report indicating the participation to the study, but not mentioning the&#xD;
      treatment group, will be sent to the attending physician and the patient. An information form&#xD;
      with postoperative instructions will be given to patients included in this protocol without&#xD;
      mentioning the surgical arm. The operative report will be given to the patient at the end of&#xD;
      her participation in the trial.&#xD;
&#xD;
      A total of five visits (including final visit) are scheduled for this trial. The patient will&#xD;
      be monitored in the form of telephone conversation or questionnaire sent by email or post.&#xD;
      Monitoring will be done by the investigator that enrolled the patient with the help of the&#xD;
      URC in charge of the project. In case of complications, failure of the intervention or&#xD;
      diagnosis of a uterine cavity pathology, the care will be left to the discretion of the&#xD;
      medical center team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2014</start_date>
  <completion_date type="Actual">July 3, 2020</completion_date>
  <primary_completion_date type="Actual">November 15, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progressive intrauterine pregnancy &gt; 22 WA</measure>
    <time_frame>Until 2 years post surgery</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Next pregnancy</measure>
    <time_frame>Until 2 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical complications' rate</measure>
    <time_frame>until 2 years post surgery</time_frame>
    <description>Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical reinterventions</measure>
    <time_frame>until 2 years post surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">577</enrollment>
  <condition>Incomplete Miscarriage</condition>
  <arm_group>
    <arm_group_label>Arm A : Operative hysteroscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>operative hysteroscopy with direct visualization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B : Aspirative curettage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>curettage is the standard surgical treatment in most centers</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hysteroscopy</intervention_name>
    <description>Performed under general or local anesthesia, antibioprophylaxis in accordance to center practices may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.</description>
    <arm_group_label>Arm A : Operative hysteroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Curettage</intervention_name>
    <description>Performed under general or local anesthesia, the used material may be rigid or flexible vacurette. In the same way, the prophylactic antibiotic, the diameter of the used vacurette, the importance of cervical dilation necessary and a possible peroperative ultrasound guidance will be left at the discretion of the operator and habits of the center. A check of the uterine vacuity by foam curette will be conducted at the end of curettage.</description>
    <arm_group_label>Arm B : Aspirative curettage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major, under 45 years with intrauterine trophoblastic retention after incomplete&#xD;
             miscarriage in the first quarter (termination of pregnancy &lt; 14 WA),&#xD;
&#xD;
          -  With desire of pregnancy ;&#xD;
&#xD;
          -  Intrauterine trophoblastic retention diagnosed by transvaginal pelvic ultrasound&#xD;
             finding a intrauterine heterogeneous image or intrauterine gestational sac more than&#xD;
             15 mm in thickness, complicated or not of endometritis ;&#xD;
&#xD;
          -  Decision to surgical management of incomplete miscarriage by the health care team ;&#xD;
&#xD;
          -  Patient beneficiary or affiliated to a health insurance&#xD;
&#xD;
          -  Informed and signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Will not be included in the protocol patients :&#xD;
&#xD;
          -  having a uterine malformation known ;&#xD;
&#xD;
          -  having received surgical treatment for the current intrauterine retention ;&#xD;
&#xD;
          -  with intrauterine retention diagnosed by transvaginal pelvic ultrasound of more than&#xD;
             50 mm in thickness ;&#xD;
&#xD;
          -  requiring a haemostatic act in urgency for heavy vaginal bleeding (miscarriage&#xD;
             haemorrhage) ;&#xD;
&#xD;
          -  bearer of intrauterine device ;&#xD;
&#xD;
          -  having an evolutive pregnancy;&#xD;
&#xD;
          -  having an ectopic pregnancy;&#xD;
&#xD;
          -  having a trophoblastic retention following a voluntary abortion ;&#xD;
&#xD;
          -  having a pregnancy achieved by medically assisted procreation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnaud FAUCONNIER, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Intercommunal de Poissy / Saint-Germain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre hospitalier intercommunal de poissy-saint germain en Laye</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incomplete miscarriage</keyword>
  <keyword>Hysteroscopy</keyword>
  <keyword>curettage, pregnancy</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Abortion, Incomplete</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/NCT02201732
org study id: P130920
secondary id: 2014-A00340-47
nct id: NCT02201732
lead sponsor: 
has dmc: No
The purpose of this study of is to compare subsequent fertility rates between hysteroscopy
      and aspirative curettage in the surgical treatment of incomplete spontaneous abortion
Incomplete spontaneous abortion (ISA) is defined by the intrauterine retention of conceptual
      product after incomplete or partial expulsion of the conceptual product. Treatment such
      retention may be expectant care, medical treatment or surgery. Currently, curettage is the
      standard surgical treatment in most centers. However, operative hysteroscopy, in addition to
      the direct visualization of the retained conceptual product, in contrast to the curettage,
      would allow elective evacuation of retention while reducing surgical complications. Studies
      of low effective, retrospective, have found an fertility's increase in patients treated by
      operative hysteroscopy. These data need to be confirmed by a randomized controlled trial in
      order to change the standard surgical treatment of this disease if hysteroscopy procedure
      would found to be superior.

      We propose a multicenter - single blind - randomized - therapeutic study. Randomization will
      concern the surgical procedure in patients treated surgically for intrauterine retention
      after spontaneous miscarriage. Randomization will be performed at the admission to the
      patient in the operating room by electronic means using a secure internet platform,
      single-blind for the patient with unblinding at the end of the trial or in case of
      complication. The patient will be randomly assigned to one of two treatment arms following:

        -  Arm A : Operative hysteroscopy

        -  Arm B : Aspirative curettage The inclusion will be performed at time of diagnosis
           (incomplete miscarriage) with an ultrasound of intrauterine retention for which surgical
           treatment has been decided. The initial medical examination (inclusion visit) will
           include a complete gynecological examination. The diagnosis of incomplete miscarriage
           will be performed using a transvaginal pelvic ultrasound. Transvaginal ultrasound will
           be performed according to a technique of standardized pelvic ultrasound ; the retention
           will be diagnosed in the presence of a heterogeneous image or intrauterine gestational
           sac more than 15 mm in thickness. On this visit, the patient will complete a
           questionnaire concerning her medical histories and the aborted pregnancy.

      Patients will have a care in accordance with center practices for the hospital stay. Surgical
      treatment will be performed within the time depending on the availability of the operating
      room of participating center.

      A hospitalization report indicating the participation to the study, but not mentioning the
      treatment group, will be sent to the attending physician and the patient. An information form
      with postoperative instructions will be given to patients included in this protocol without
      mentioning the surgical arm. The operative report will be given to the patient at the end of
      her participation in the trial.

      A total of five visits (including final visit) are scheduled for this trial. The patient will
      be monitored in the form of telephone conversation or questionnaire sent by email or post.
      Monitoring will be done by the investigator that enrolled the patient with the help of the
      URC in charge of the project. In case of complications, failure of the intervention or
      diagnosis of a uterine cavity pathology, the care will be left to the discretion of the
      medical center team.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Progressive intrauterine pregnancy > 22 WA
time frame: Until 2 years post surgery
description: Questionnaire
measure: Next pregnancy
time frame: Until 2 years post surgery
measure: Surgical complications' rate
time frame: until 2 years post surgery
description: Clavien-Dindo classification
measure: Surgical reinterventions
time frame: until 2 years post surgery
arm group label: Arm A : Operative hysteroscopy
arm group type: Experimental
description: operative hysteroscopy with direct visualization
arm group label: Arm B : Aspirative curettage
arm group type: Active Comparator
description: curettage is the standard surgical treatment in most centers
intervention type: Procedure
intervention name: Hysteroscopy
description: Performed under general or local anesthesia, antibioprophylaxis in accordance to center practices may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
arm group label: Arm A : Operative hysteroscopy
intervention type: Procedure
intervention name: Curettage
description: Performed under general or local anesthesia, the used material may be rigid or flexible vacurette. In the same way, the prophylactic antibiotic, the diameter of the used vacurette, the importance of cervical dilation necessary and a possible peroperative ultrasound guidance will be left at the discretion of the operator and habits of the center. A check of the uterine vacuity by foam curette will be conducted at the end of curettage.
arm group label: Arm B : Aspirative curettage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
last name: Arnaud FAUCONNIER, MD, PhD
role: Study Director
affiliation: Centre Hospitalier Intercommunal de Poissy / Saint-Germain
facility: 
country: France
responsible party type: Sponsor
mesh term: Abortion, Spontaneous
mesh term: Abortion, Incomplete