<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/NCT02969447</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2016/20</org_study_id>
    <nct_id>NCT02969447</nct_id>
  </id_info>
  <brief_title>Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination</brief_title>
  <acronym>ANDDROID</acronym>
  <official_title>Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective randomized trail which compare 2 regimens for third-stage management after second&#xD;
      trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional&#xD;
      medication after fetal expulsion. Primary outcome was the incidence of placental retention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Complication of third stage of labor in second trimester medical pregnancy termination is not&#xD;
      well studied. Accord to publications, the placental retention rate is 30 to 40% in these&#xD;
      situations. Placental retention may be associated with increased blood loss, increased&#xD;
      requirement for blood transfusion anesthetic and operative complications, and infectious&#xD;
      morbidity. The high incidence of retained placenta is an area of clinical concern.&#xD;
      Publications reveal a wide variation in practices but there are only few studies about third&#xD;
      stage of labor in second trimester medical pregnancy termination. The study is a prospective&#xD;
      randomized trial. Two third stage management strategies are compared: 10 units of intra&#xD;
      venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It&#xD;
      concerns pregnancies between 14 and 28 weeks gestation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2016</start_date>
  <completion_date type="Actual">August 4, 2017</completion_date>
  <primary_completion_date type="Actual">August 4, 2017</primary_completion_date>
  <phase>Phase 4</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>Incidence of placental retention</measure>
    <time_frame>Up to 30 minutes after fetal expulsion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of partial placental retention</measure>
    <time_frame>Up to 1 hour after fetal expulsion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of digital exploration</measure>
    <time_frame>Up to 1 hour after fetal expulsion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of blunt curettage</measure>
    <time_frame>Up to 1 hour after fetal expulsion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of post-partum hemorrhage</measure>
    <time_frame>Up to 1 hour after fetal expulsion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>Up to 1 hour after fetal expulsion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Retained Placenta</condition>
  <arm_group>
    <arm_group_label>Oxytocin administration after fetal expulsion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of 10 units of intra venous oxytocin after fetal expulsion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No additional medication after fetal expulsion</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Administration of 10 units of intra venous oxytocin after fetal expulsion</intervention_name>
    <arm_group_label>Oxytocin administration after fetal expulsion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old and older&#xD;
&#xD;
          -  medical pregnancy termination between 14 and 28 weeks gestation&#xD;
&#xD;
          -  informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years old&#xD;
&#xD;
          -  refusal to consent&#xD;
&#xD;
          -  in utero fetal death&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Retained Placenta</keyword>
  <keyword>Second trimester medical termination</keyword>
  <keyword>Third stage labor</keyword>
  <keyword>Oxytocin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta, Retained</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02969447
org study id: CHUBX 2016/20
nct id: NCT02969447
lead sponsor: 
has dmc: No
Prospective randomized trail which compare 2 regimens for third-stage management after second
      trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional
      medication after fetal expulsion. Primary outcome was the incidence of placental retention.
Complication of third stage of labor in second trimester medical pregnancy termination is not
      well studied. Accord to publications, the placental retention rate is 30 to 40% in these
      situations. Placental retention may be associated with increased blood loss, increased
      requirement for blood transfusion anesthetic and operative complications, and infectious
      morbidity. The high incidence of retained placenta is an area of clinical concern.
      Publications reveal a wide variation in practices but there are only few studies about third
      stage of labor in second trimester medical pregnancy termination. The study is a prospective
      randomized trial. Two third stage management strategies are compared: 10 units of intra
      venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It
      concerns pregnancies between 14 and 28 weeks gestation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of placental retention
time frame: Up to 30 minutes after fetal expulsion
measure: Incidence of partial placental retention
time frame: Up to 1 hour after fetal expulsion
measure: Incidence of digital exploration
time frame: Up to 1 hour after fetal expulsion
measure: Incidence of blunt curettage
time frame: Up to 1 hour after fetal expulsion
measure: Incidence of post-partum hemorrhage
time frame: Up to 1 hour after fetal expulsion
measure: Blood loss
time frame: Up to 1 hour after fetal expulsion
arm group label: Oxytocin administration after fetal expulsion
arm group type: Experimental
description: Administration of 10 units of intra venous oxytocin after fetal expulsion
arm group label: No additional medication after fetal expulsion
arm group type: No Intervention
intervention type: Drug
intervention name: Administration of 10 units of intra venous oxytocin after fetal expulsion
arm group label: Oxytocin administration after fetal expulsion
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Placenta, Retained
mesh term: Oxytocin
sharing ipd: Undecided