<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/NCT03043014</url>
  </required_header>
  <id_info>
    <org_study_id>2016-35</org_study_id>
    <nct_id>NCT03043014</nct_id>
  </id_info>
  <brief_title>Cervical Preparation of Abortions Under Paracervical Block in the First Trimester:</brief_title>
  <acronym>BPCEN</acronym>
  <official_title>Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Surgical abortion is one of the most frequently surgery of women in the world. 43 millions&#xD;
      are annually performed in the world.&#xD;
&#xD;
      90% of the abortions are performed during the first trimester of pregnancy before 13 weeks.&#xD;
      Legal surgical abortion during the first trimester of pregnancy is a low risk intervention&#xD;
      with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 %&#xD;
      to 3.4 %.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical abortion is one of the most frequently surgery of women in the world. 43 millions&#xD;
      are annually performed in the world.&#xD;
&#xD;
      Legal surgical abortion during the first trimester of pregnancy is a low risk intervention&#xD;
      with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 %&#xD;
      to 3.4 %. In France, about 75 % of the surgical abortions are performed under general&#xD;
      anesthesia (GA). Nevertheless, the risk of complications is higher under GA. The risk of&#xD;
      death is more important (0,58 for 100 000) with GA. GA increases by a factor 1,7 the risk of&#xD;
      bleeding, 2,2 the risk of uterine perforation, 8,2 the risk of intra-abdominal bleeding, 2,9&#xD;
      the risk of cervical tearing, and 5 the risk of transfusion. The difficulty of pain control&#xD;
      under local anesthetia (LA) explains this method is less choosen by the women. Indeed, a lot&#xD;
      of women consider the surgical abortion under LA extremely uncomfortable. The paracervical&#xD;
      block for the abortion under LA in the first trimester demonstrated its efficiency in the&#xD;
      reduction of the per-operating pain whatever the term of the pregnancy compared with the&#xD;
      absence of anesthesia. The cervical preparation demonstrated benefits in term of cervical&#xD;
      dilation, per-operating bleeding, and complications incidence. The misoprostol and the&#xD;
      mifepristone are 2 molecules recommended for the cervical preparation on the first trimester&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">November 15, 2022</completion_date>
  <primary_completion_date type="Actual">March 13, 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>
    <intervention_model_description>The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . We assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>per operative pain</measure>
    <time_frame>20 minutes</time_frame>
    <description>It is carried out using a numerical scale rated from 0 to 10 (0 absence of pain, 10 maximum of pains felt).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>48 hours</time_frame>
    <description>STAI anxiety questionnaire;it is a self-questionnaire, developed by Spielberger (Spielberger, 1983) and validated in French (Gauthier &amp; Bouchard, 1993). It consists of 20 questions, assessing the usual emotional state of the subject. A score is calculated, a high score indicating the presence of anxiety.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Surgical Abortion</condition>
  <arm_group>
    <arm_group_label>Mifépristone group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>misoprostol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifépristone versus Misoprostol</intervention_name>
    <description>The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . The investigators assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.</description>
    <arm_group_label>Mifépristone group</arm_group_label>
    <arm_group_label>misoprostol group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        aged 18 or over with a single intra uterine pregnancy whose term is between 6 and 14 weeks&#xD;
        the day of the abortion estimated by ultrasound by a measurement of the cranio-caudal&#xD;
        length between 5 and 84 millimeters surgical abortion under local anesthesia informed&#xD;
        written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        minor multiple pregnancy Uterine malformation coagulation disorder defined by biological&#xD;
        parameters (TP&lt;70%, TCA patient / control ratio &lt; 1.20) Allergy or hypersensitivity to any&#xD;
        of the active substance or to any of the excipients Contraindication to mifepristone&#xD;
        chronic renal insufficiency severe asthma uncontrolled by treatment hereditary porphyria&#xD;
        allergy to the active substance or to any of the excipients; not affiliated to the social&#xD;
        security system; no informed consent. Suspicion of ectopic pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle DESALBRES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital de la conception Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Mifepristone</mesh_term>
  </intervention_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/NCT03043014
org study id: 2016-35
nct id: NCT03043014
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions
      are annually performed in the world.

      90% of the abortions are performed during the first trimester of pregnancy before 13 weeks.
      Legal surgical abortion during the first trimester of pregnancy is a low risk intervention
      with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 %
      to 3.4 %.
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions
      are annually performed in the world.

      Legal surgical abortion during the first trimester of pregnancy is a low risk intervention
      with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 %
      to 3.4 %. In France, about 75 % of the surgical abortions are performed under general
      anesthesia (GA). Nevertheless, the risk of complications is higher under GA. The risk of
      death is more important (0,58 for 100 000) with GA. GA increases by a factor 1,7 the risk of
      bleeding, 2,2 the risk of uterine perforation, 8,2 the risk of intra-abdominal bleeding, 2,9
      the risk of cervical tearing, and 5 the risk of transfusion. The difficulty of pain control
      under local anesthetia (LA) explains this method is less choosen by the women. Indeed, a lot
      of women consider the surgical abortion under LA extremely uncomfortable. The paracervical
      block for the abortion under LA in the first trimester demonstrated its efficiency in the
      reduction of the per-operating pain whatever the term of the pregnancy compared with the
      absence of anesthesia. The cervical preparation demonstrated benefits in term of cervical
      dilation, per-operating bleeding, and complications incidence. The misoprostol and the
      mifepristone are 2 molecules recommended for the cervical preparation on the first trimester
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . We assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.
primary purpose: Treatment
masking: Single (Investigator)
measure: per operative pain
time frame: 20 minutes
description: It is carried out using a numerical scale rated from 0 to 10 (0 absence of pain, 10 maximum of pains felt).
measure: Anxiety
time frame: 48 hours
description: STAI anxiety questionnaire;it is a self-questionnaire, developed by Spielberger (Spielberger, 1983) and validated in French (Gauthier & Bouchard, 1993). It consists of 20 questions, assessing the usual emotional state of the subject. A score is calculated, a high score indicating the presence of anxiety.
arm group label: Mifépristone group
arm group type: Experimental
arm group label: misoprostol group
arm group type: Active Comparator
intervention type: Drug
intervention name: Mifépristone versus Misoprostol
description: The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . The investigators assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.
arm group label: Mifépristone group
arm group label: misoprostol group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urielle DESALBRES
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Misoprostol
mesh term: Mifepristone
sharing ipd: No