<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/NCT04467996</url>
  </required_header>
  <id_info>
    <org_study_id>19-3070</org_study_id>
    <nct_id>NCT04467996</nct_id>
  </id_info>
  <brief_title>Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage</brief_title>
  <official_title>Evaluation of the Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Denver Health and Hospital Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Denver Health and Hospital Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to&#xD;
      treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this&#xD;
      therapy, little is known about how long the IUBT should be used once placed. Though it is&#xD;
      common to use IUBT for 12-24 hours, the balloon may be equally effective when used for&#xD;
      shorter durations of time, which could have beneficial effects for patients and hospitals.&#xD;
      The proposed study is a pragmatic randomized controlled trial of non-inferiority comparing&#xD;
      two durations of time for intrauterine balloon tamponade placement, 6 and 18 hours, in&#xD;
      controlling postpartum hemorrhage.&#xD;
&#xD;
      The specific aims of the proposed study are to determine: 1) whether quantitative blood loss&#xD;
      significantly differs when the balloon is removed in 6 hours compared to 18 hours, 2) whether&#xD;
      hemorrhage-related morbidity differs when the IUBT is kept in place for 6 or 18 hours, and 3)&#xD;
      whether shorter duration of IUBT placement has beneficial effects including shortened&#xD;
      postpartum hospital stays, improved maternal-infant bonding, and reduced postpartum pain&#xD;
      prior to maternal discharge from hospital.&#xD;
&#xD;
      We hypothesize that, once hemorrhage control has been achieved with IUBT placement, there is&#xD;
      no clinically significant difference in postpartum blood loss when the balloon is removed 6&#xD;
      hours after placement compared to 18 hours after placement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">October 19, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantitative blood loss</measure>
    <time_frame>18 hours</time_frame>
    <description>total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postpartum hemorrhage related outcomes</measure>
    <time_frame>during admission</time_frame>
    <description>return to the OR, replacement of the IUBT, hysterectomy, pelvic artery embolization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>during admission</time_frame>
    <description>change in hematocrit from admission to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum length of stay</measure>
    <time_frame>during admission</time_frame>
    <description>Length of stay in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometritis</measure>
    <time_frame>during admission</time_frame>
    <description>diagnosed postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chorioamnionitis</measure>
    <time_frame>during admission</time_frame>
    <description>requiring more than one dose of antibiotics postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion of packed red blood cells</measure>
    <time_frame>during admission</time_frame>
    <description>after IUBT placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal-infant bonding</measure>
    <time_frame>during admission</time_frame>
    <description>measured by the mother-to-infant bonding scale (MIBS), scale 0-27, higher score indicates worse maternal-infant bonding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal pain</measure>
    <time_frame>during admission</time_frame>
    <description>measured by the visual analogue scale (VAS), scale 0-10, higher score indicates worse pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Postpartum Hemorrhage, Immediate</condition>
  <arm_group>
    <arm_group_label>6 hour IUBT placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>18 hour IUBT placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intrauterine balloon tamponade</intervention_name>
    <description>Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.</description>
    <arm_group_label>18 hour IUBT placement</arm_group_label>
    <arm_group_label>6 hour IUBT placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women at Denver Health and Hospital Authority (DHHA) who have an IUBT placed for&#xD;
             postpartum hemorrhage due to uterine atony will be approached for enrollment in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women will be excluded from the study if they: are less than 18 years of age; had a&#xD;
             cesarean delivery; are unable to consent for themselves; have a preexisting or&#xD;
             acquired clotting factor disorder such as von Willebrand or hemophilia, disseminated&#xD;
             intravascular coagulation, or therapeutic anticoagulation at time of delivery; would&#xD;
             refuse blood product transfusion; have a fetal demise or birth of a previable fetus;&#xD;
             or are incarcerated at the time of delivery. Women who do not speak English or Spanish&#xD;
             will be offered enrollment if a phone interpreter is available to review the consent,&#xD;
             but will be excluded from the survey portion of the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Denver Health Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Denver Health and Hospital Authority</investigator_affiliation>
    <investigator_full_name>LARREANICOLE</investigator_full_name>
    <investigator_title>Obstetrician Gynegologist, Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT04467996
org study id: 19-3070
nct id: NCT04467996
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to
      treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this
      therapy, little is known about how long the IUBT should be used once placed. Though it is
      common to use IUBT for 12-24 hours, the balloon may be equally effective when used for
      shorter durations of time, which could have beneficial effects for patients and hospitals.
      The proposed study is a pragmatic randomized controlled trial of non-inferiority comparing
      two durations of time for intrauterine balloon tamponade placement, 6 and 18 hours, in
      controlling postpartum hemorrhage.

      The specific aims of the proposed study are to determine: 1) whether quantitative blood loss
      significantly differs when the balloon is removed in 6 hours compared to 18 hours, 2) whether
      hemorrhage-related morbidity differs when the IUBT is kept in place for 6 or 18 hours, and 3)
      whether shorter duration of IUBT placement has beneficial effects including shortened
      postpartum hospital stays, improved maternal-infant bonding, and reduced postpartum pain
      prior to maternal discharge from hospital.

      We hypothesize that, once hemorrhage control has been achieved with IUBT placement, there is
      no clinically significant difference in postpartum blood loss when the balloon is removed 6
      hours after placement compared to 18 hours after placement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quantitative blood loss
time frame: 18 hours
description: total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads
measure: Postpartum hemorrhage related outcomes
time frame: during admission
description: return to the OR, replacement of the IUBT, hysterectomy, pelvic artery embolization
measure: Hematocrit
time frame: during admission
description: change in hematocrit from admission to discharge
measure: Postpartum length of stay
time frame: during admission
description: Length of stay in hours
measure: Endometritis
time frame: during admission
description: diagnosed postpartum
measure: Chorioamnionitis
time frame: during admission
description: requiring more than one dose of antibiotics postpartum
measure: Transfusion of packed red blood cells
time frame: during admission
description: after IUBT placement
measure: Maternal-infant bonding
time frame: during admission
description: measured by the mother-to-infant bonding scale (MIBS), scale 0-27, higher score indicates worse maternal-infant bonding
measure: Maternal pain
time frame: during admission
description: measured by the visual analogue scale (VAS), scale 0-10, higher score indicates worse pain
arm group label: 6 hour IUBT placement
arm group type: Active Comparator
arm group label: 18 hour IUBT placement
arm group type: Active Comparator
intervention type: Device
intervention name: Intrauterine balloon tamponade
description: Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.
arm group label: 18 hour IUBT placement
arm group label: 6 hour IUBT placement
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Denver Health and Hospital Authority
investigator full name: LARREANICOLE
investigator title: Obstetrician Gynegologist, Assistant Professor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: Undecided