<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/NCT02226731</url>
  </required_header>
  <id_info>
    <org_study_id>P130914</org_study_id>
    <nct_id>NCT02226731</nct_id>
  </id_info>
  <brief_title>Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage</brief_title>
  <acronym>TUB</acronym>
  <official_title>Assessment of the Efficacy of Early Intrauterine Tamponade With a Belfort-Dildy Balloon Obstetric Tamponade System in the Treatment of Immediate Postpartum Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to evaluate the impact of early intrauterine tamponade with a&#xD;
      Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal&#xD;
      delivery and refractory to first-line uterotonic treatment, ie performed at the same time as&#xD;
      second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case&#xD;
      of failure of second line uterotonic treatment, on the final severity of PPH. ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immediate postpartum hemorrhage (IPPH) is among the most frequent causes of pregnancy-related&#xD;
      mortality in both the USA and in Europe. In France, IPPH remains the leading cause of&#xD;
      maternal mortality, responsible for 18% of the maternal deaths and 90% of the deaths from&#xD;
      IPPH are considered avoidable. The initial treatment of severe IPPH involves medical&#xD;
      management, uterine massage, and uterotonic drugs such as oxytocin, ergometrine, and&#xD;
      prostaglandins or their analogues; In France oxytocin is used as the first line uterotonic,&#xD;
      and Sulprostone as the second line uterotonic. When these first-line medical treatments fail,&#xD;
      invasive therapies, including uterine compression suture, pelvic vascular ligation, or&#xD;
      arterial embolization can be used, individually or in combination. Hysterectomy is the&#xD;
      ultimate measure to control a hemorrhage and save the mother's life. Nonetheless, the&#xD;
      management of severe IPPH is less well standardized than its prevention, especially after the&#xD;
      failure of uterotonic drugs, as demonstrated by the heterogeneity of practices between&#xD;
      countries and even between hospitals in the same country. These invasive treatments require&#xD;
      specific and expensive technical and human resources and have adverse effects. That is why,&#xD;
      over the last years, intra-uterine tamponade with balloon has been increasingly used; indeed,&#xD;
      it is a new minimally invasive method that can be used directly in the delivery room, at the&#xD;
      initial stage of second-line treatments; it could accelerate the control of IPPH, limit&#xD;
      recourse to these surgical or interventional radiology treatments, and reduce the quantity of&#xD;
      blood products transfused. Intrauterine balloon tamponade thus appears to be a potentially&#xD;
      additional effective strategy for obtaining hemostasis in the case of IPPH refractory to&#xD;
      conventional uterotonic treatments. Despite the fact that the current literature assessing&#xD;
      its efficacy is limited to case series and before-after observational studies, the available&#xD;
      evidence suggests that it is associated with a drop in the need for invasive treatments.&#xD;
      Based on this evidence, intra-uterine tamponade balloon has been included in guidelines for&#xD;
      PPH treatment in many countries, including France, and it has widely spread in clinical&#xD;
      practices. The clinical question that is now arising is its optimal timing in the management&#xD;
      of PPH. It is currently classically performed after failure of second-line uterotonic&#xD;
      treatment but it is possible that its earlier use, after failure of first-line uterotonic&#xD;
      treatment, could further decrease the rate of severe PPH.&#xD;
&#xD;
      A randomized controlled trial is therefore necessary to determine the optimal timing of&#xD;
      intrauterine balloon tamponade in the treatment of PPH. .&#xD;
&#xD;
      We propose a multicenter, randomized open treatment trial with two parallel arms. The trial&#xD;
      will be conducted in 21 maternity units. Before inclusions begin, the medical staff will be&#xD;
      trained in the use of the obstetric tamponade system to be used in the trial. For each woman&#xD;
      with IPPH refractory to first line uterotonic, the eligibility criteria will be immediately&#xD;
      verified, the woman informed and her written informed consent obtained if that is possible.&#xD;
      If not, the woman can nonetheless be randomized and she will be secondarily informed and her&#xD;
      consent requested. The randomization list will be centralized and generated by a computer&#xD;
      program under the supervision of the Paris Centre Clinical Research Unit. Allocation to a&#xD;
      study arm will be performed on a secure Internet platform (CleanWeb) always accessible (24/7)&#xD;
      in each delivery room. The clinician including the patient will know her allocation&#xD;
      immediately.&#xD;
&#xD;
      The management of randomized women will depend on the arm to which they are allocated:&#xD;
&#xD;
        -  In the Experimental arm : the intravenous second line uterotonic Sulprostone infusion&#xD;
           will be immediately combined with an intrauterine tamponade with the Belfort-Dildy&#xD;
           balloon. Balloon insertion and inflation will follow a standardized protocol. Its&#xD;
           intrauterine position will be verified by abdominal ultrasound. If the bleeding persists&#xD;
           from the cervix or the balloon catheter drainage port 30 minutes after the beginning of&#xD;
           the Sulprostone infusion, the tamponade will be considered a failure and an invasive&#xD;
           emergency procedure by interventional radiology or surgery will be arranged and&#xD;
           performed immediately after the removal of the balloon in the operating room.&#xD;
&#xD;
        -  In the Control arm, women will only receive the Sulprostone infusion first. If bleeding&#xD;
           persists 30 minutes after the beginning of this infusion, an intrauterine tamponade with&#xD;
           the Belfort-Dildy balloon will be performed. Balloon insertion and inflation will be&#xD;
           performed following the standardized protocol. If the bleeding persists from the cervix&#xD;
           or the balloon catheter drainage port 15 to 30 minutes after the introduction of the&#xD;
           balloon, the tamponade will be considered a failure and an invasive emergency procedure&#xD;
           by interventional radiology or surgery will be arranged and performed immediately after&#xD;
           the removal of the balloon in the operating room.&#xD;
&#xD;
      In both arms, all patients will have an indwelling urinary catheter and will receive&#xD;
      antibiotic prophylaxis (amoxicillin-clavulanic acid and gentamicin) beginning with the&#xD;
      Sulprostone infusion and continuing for 48 hours. The other components of IPPH management&#xD;
      (fluid resuscitation, transfusion, resuscitation) will comply with national guidelines. If&#xD;
      the bleeding stops, the patient will be transferred to a continuous care or&#xD;
      post-interventional monitoring unit. Monitoring will be conducted by the investigator who&#xD;
      included the patient. A venous blood sample will be collected on the 2nd day postpartum to&#xD;
      measure hemoglobin and hematocrit values. The data will be entered as they are collected&#xD;
      throughout the trial with Cleanweb software.&#xD;
&#xD;
      The duration of the participation of each patient included in the trial will be from&#xD;
      inclusion through postpartum visit, or a maximum of approximately 8 weeks after the delivery.&#xD;
      The maximum duration of study treatment will be 24 hours for each patient included in the&#xD;
      protocol.&#xD;
&#xD;
      The total duration of the trial will be 36 months including 24 months of patient inclusion:&#xD;
      the first 4 months, before the beginning of the inclusion period will be devoted to training&#xD;
      staff in the use of the balloon tamponade system and in compliance with the trial protocol&#xD;
      and the 8 months following the end of the inclusion period will be used to finalize the data&#xD;
      collection, clean the database and analyze it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">August 18, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Proportion of women who received at least 3 RBC units for the treatment of PPH and /or who had a calculated peripartum blood loss &gt; 1000 ml.</measure>
    <time_frame>1 day</time_frame>
    <description>With Calculated peripartum blood loss= estimated blood volume × ((prepartum Ht - Day 2postpartum Ht)/prepartum Ht ) and Estimated blood volume (ml) = booking weight (kg) × 85)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>1 day</time_frame>
    <description>Incidence of each component of the primary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>24 hours</time_frame>
    <description>Proportion of women with a total blood loss in the first 24 hours postpartum ≥ 1500 mL (estimated or measured).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>8 days</time_frame>
    <description>Proportion of women receiving a postpartum RBC transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>8 days</time_frame>
    <description>Mean number of units of packed red blood cells transfused in postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>8 days</time_frame>
    <description>Proportion of women receiving at least 4 units of packed red blood cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>2 days</time_frame>
    <description>Proportion of women with a difference ≥ 4 g/dL between the hemoglobin value before and on the 2nd day after delivery in the absence of a transfusion of packed red blood cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>2 days</time_frame>
    <description>Mean difference between the hemoglobin values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>2 days</time_frame>
    <description>Mean difference between the hematocrit values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>2 days</time_frame>
    <description>Total calculated peripartum blood loss&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>2 days</time_frame>
    <description>Proportion of women with a total calculated peripartum blood loss ≥ 1500 mL&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>2 days</time_frame>
    <description>Proportion of women transferred to Intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>1 day</time_frame>
    <description>Proportion of women who had invasive second line therapy, any of the following : arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>other Genital tract infection</measure>
    <time_frame>8 days</time_frame>
    <description>Assessed by :&#xD;
Proportion of women with a temperature &gt;38°5C during postpartum hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>other Genital tract infection</measure>
    <time_frame>8 days</time_frame>
    <description>Assessed by :&#xD;
Proportion of women with endometritis during postpartum hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>other Genital tract infection</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed by :&#xD;
• Proportion of women who had endometritis at the 6 weeks postpartum visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>24 hours</time_frame>
    <description>Proportion of women with a total blood loss in the first 24 hours postpartum ≥ 2000 mL (estimated or measured)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other markers of severe hemorrhage</measure>
    <time_frame>2 days</time_frame>
    <description>Proportion of women with a total calculated peripartum blood loss ≥ 2000 mL</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">405</enrollment>
  <condition>Immediate Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Early Belfort-Dildy balloon device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Late Belfort-Dildy balloon device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Early Belfort-Dildy Balloon</intervention_name>
    <description>Intrauterine tamponade with the Belfort-Dildy balloon, performed in the 15 minutes after randomization at the same time as the second line uterotonic treatment.</description>
    <arm_group_label>Early Belfort-Dildy balloon device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Late Belfort-Dildy balloon</intervention_name>
    <description>Intrauterine tamponade with the Belfort-Dildy balloon, performed if failure of second line uterotonic treatment, ie persisting bleeding 30 minutes after the beginning of this infusion.</description>
    <arm_group_label>Late Belfort-Dildy balloon device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The trial will include women:&#xD;
&#xD;
          -  aged 18 years or older,&#xD;
&#xD;
          -  who have just had a vaginal delivery&#xD;
&#xD;
          -  between 35 and 42 weeks of gestation&#xD;
&#xD;
          -  with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by&#xD;
             slow IV and uterine massage,&#xD;
&#xD;
          -  and who provided informed written consent. If her condition does not allow her consent&#xD;
             to be obtained immediately in ethically acceptable conditions, it may be obtained from&#xD;
             her healthcare agent, or if there is none, from a family member, if present. In case&#xD;
             where neither a healthcare agent nor a family member is present on the day of&#xD;
             inclusion, the patient can nonetheless be included. She will be informed secondarily,&#xD;
             and her consent will be requested for the potential continuation of the research and&#xD;
             use of her data&#xD;
&#xD;
          -  Patient beneficiary or affiliated to a health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The trial will not include women:&#xD;
&#xD;
          -  who have just had a cesarean delivery&#xD;
&#xD;
          -  with a contraindication to Sulprostone&#xD;
&#xD;
          -  with clinical chorioamnionitis or an in utero fetal death&#xD;
&#xD;
          -  or a medically-indicated termination of pregnancy&#xD;
&#xD;
          -  with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage,&#xD;
             uterine rupture, or placenta accreta&#xD;
&#xD;
          -  with arterial bleeding requiring embolization&#xD;
&#xD;
          -  with a purulent infection of the cervix, vagina or uterus&#xD;
&#xD;
          -  with symptoms indicating a hysterectomy&#xD;
&#xD;
          -  with cervical cancer&#xD;
&#xD;
          -  with a uterine malformation&#xD;
&#xD;
          -  or who refuses to sign the informed consent.&#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>Patrick ROZENBERG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics, Poissy-Saint Germain Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine DENEUX - THARAUX, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institut National de la Santé Et de la Recherche Médicale, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHI de Poissy Saint Germain en Laye</name>
      <address>
        <city>Poissy</city>
        <zip>78303</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage. Am J Obstet Gynecol. 2012 Oct;207(4):281.e1-7. doi: 10.1016/j.ajog.2012.08.028. Epub 2012 Aug 17.</citation>
    <PMID>23021688</PMID>
  </reference>
  <reference>
    <citation>Georgiou C. Balloon tamponade in the management of postpartum haemorrhage: a review. BJOG. 2009 May;116(6):748-57. doi: 10.1111/j.1471-0528.2009.02113.x.</citation>
    <PMID>19432563</PMID>
  </reference>
  <reference>
    <citation>Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):5-14. doi: 10.1111/j.1471-0528.2012.03454.x. Epub 2012 Aug 13.</citation>
    <PMID>22882240</PMID>
  </reference>
  <reference>
    <citation>Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG. 2017 Jul;124(8):1255-1262. doi: 10.1111/1471-0528.14382. Epub 2016 Oct 25.</citation>
    <PMID>27781401</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immediate postpartum hemorrhage</keyword>
  <keyword>Intrauterine balloon tamponade</keyword>
  <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>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/NCT02226731
org study id: P130914
nct id: NCT02226731
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the impact of early intrauterine tamponade with a
      Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal
      delivery and refractory to first-line uterotonic treatment, ie performed at the same time as
      second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case
      of failure of second line uterotonic treatment, on the final severity of PPH. ).
Immediate postpartum hemorrhage (IPPH) is among the most frequent causes of pregnancy-related
      mortality in both the USA and in Europe. In France, IPPH remains the leading cause of
      maternal mortality, responsible for 18% of the maternal deaths and 90% of the deaths from
      IPPH are considered avoidable. The initial treatment of severe IPPH involves medical
      management, uterine massage, and uterotonic drugs such as oxytocin, ergometrine, and
      prostaglandins or their analogues; In France oxytocin is used as the first line uterotonic,
      and Sulprostone as the second line uterotonic. When these first-line medical treatments fail,
      invasive therapies, including uterine compression suture, pelvic vascular ligation, or
      arterial embolization can be used, individually or in combination. Hysterectomy is the
      ultimate measure to control a hemorrhage and save the mother's life. Nonetheless, the
      management of severe IPPH is less well standardized than its prevention, especially after the
      failure of uterotonic drugs, as demonstrated by the heterogeneity of practices between
      countries and even between hospitals in the same country. These invasive treatments require
      specific and expensive technical and human resources and have adverse effects. That is why,
      over the last years, intra-uterine tamponade with balloon has been increasingly used; indeed,
      it is a new minimally invasive method that can be used directly in the delivery room, at the
      initial stage of second-line treatments; it could accelerate the control of IPPH, limit
      recourse to these surgical or interventional radiology treatments, and reduce the quantity of
      blood products transfused. Intrauterine balloon tamponade thus appears to be a potentially
      additional effective strategy for obtaining hemostasis in the case of IPPH refractory to
      conventional uterotonic treatments. Despite the fact that the current literature assessing
      its efficacy is limited to case series and before-after observational studies, the available
      evidence suggests that it is associated with a drop in the need for invasive treatments.
      Based on this evidence, intra-uterine tamponade balloon has been included in guidelines for
      PPH treatment in many countries, including France, and it has widely spread in clinical
      practices. The clinical question that is now arising is its optimal timing in the management
      of PPH. It is currently classically performed after failure of second-line uterotonic
      treatment but it is possible that its earlier use, after failure of first-line uterotonic
      treatment, could further decrease the rate of severe PPH.

      A randomized controlled trial is therefore necessary to determine the optimal timing of
      intrauterine balloon tamponade in the treatment of PPH. .

      We propose a multicenter, randomized open treatment trial with two parallel arms. The trial
      will be conducted in 21 maternity units. Before inclusions begin, the medical staff will be
      trained in the use of the obstetric tamponade system to be used in the trial. For each woman
      with IPPH refractory to first line uterotonic, the eligibility criteria will be immediately
      verified, the woman informed and her written informed consent obtained if that is possible.
      If not, the woman can nonetheless be randomized and she will be secondarily informed and her
      consent requested. The randomization list will be centralized and generated by a computer
      program under the supervision of the Paris Centre Clinical Research Unit. Allocation to a
      study arm will be performed on a secure Internet platform (CleanWeb) always accessible (24/7)
      in each delivery room. The clinician including the patient will know her allocation
      immediately.

      The management of randomized women will depend on the arm to which they are allocated:

        -  In the Experimental arm : the intravenous second line uterotonic Sulprostone infusion
           will be immediately combined with an intrauterine tamponade with the Belfort-Dildy
           balloon. Balloon insertion and inflation will follow a standardized protocol. Its
           intrauterine position will be verified by abdominal ultrasound. If the bleeding persists
           from the cervix or the balloon catheter drainage port 30 minutes after the beginning of
           the Sulprostone infusion, the tamponade will be considered a failure and an invasive
           emergency procedure by interventional radiology or surgery will be arranged and
           performed immediately after the removal of the balloon in the operating room.

        -  In the Control arm, women will only receive the Sulprostone infusion first. If bleeding
           persists 30 minutes after the beginning of this infusion, an intrauterine tamponade with
           the Belfort-Dildy balloon will be performed. Balloon insertion and inflation will be
           performed following the standardized protocol. If the bleeding persists from the cervix
           or the balloon catheter drainage port 15 to 30 minutes after the introduction of the
           balloon, the tamponade will be considered a failure and an invasive emergency procedure
           by interventional radiology or surgery will be arranged and performed immediately after
           the removal of the balloon in the operating room.

      In both arms, all patients will have an indwelling urinary catheter and will receive
      antibiotic prophylaxis (amoxicillin-clavulanic acid and gentamicin) beginning with the
      Sulprostone infusion and continuing for 48 hours. The other components of IPPH management
      (fluid resuscitation, transfusion, resuscitation) will comply with national guidelines. If
      the bleeding stops, the patient will be transferred to a continuous care or
      post-interventional monitoring unit. Monitoring will be conducted by the investigator who
      included the patient. A venous blood sample will be collected on the 2nd day postpartum to
      measure hemoglobin and hematocrit values. The data will be entered as they are collected
      throughout the trial with Cleanweb software.

      The duration of the participation of each patient included in the trial will be from
      inclusion through postpartum visit, or a maximum of approximately 8 weeks after the delivery.
      The maximum duration of study treatment will be 24 hours for each patient included in the
      protocol.

      The total duration of the trial will be 36 months including 24 months of patient inclusion:
      the first 4 months, before the beginning of the inclusion period will be devoted to training
      staff in the use of the balloon tamponade system and in compliance with the trial protocol
      and the 8 months following the end of the inclusion period will be used to finalize the data
      collection, clean the database and analyze it.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of women who received at least 3 RBC units for the treatment of PPH and /or who had a calculated peripartum blood loss > 1000 ml.
time frame: 1 day
description: With Calculated peripartum blood loss= estimated blood volume × ((prepartum Ht - Day 2postpartum Ht)/prepartum Ht ) and Estimated blood volume (ml) = booking weight (kg) × 85)
measure: Other markers of severe hemorrhage
time frame: 1 day
description: Incidence of each component of the primary outcome
measure: Other markers of severe hemorrhage
time frame: 24 hours
description: Proportion of women with a total blood loss in the first 24 hours postpartum ≥ 1500 mL (estimated or measured).
measure: Other markers of severe hemorrhage
time frame: 8 days
description: Proportion of women receiving a postpartum RBC transfusion
measure: Other markers of severe hemorrhage
time frame: 8 days
description: Mean number of units of packed red blood cells transfused in postpartum
measure: Other markers of severe hemorrhage
time frame: 8 days
description: Proportion of women receiving at least 4 units of packed red blood cells.
measure: Other markers of severe hemorrhage
time frame: 2 days
description: Proportion of women with a difference ≥ 4 g/dL between the hemoglobin value before and on the 2nd day after delivery in the absence of a transfusion of packed red blood cells.
measure: Other markers of severe hemorrhage
time frame: 2 days
description: Mean difference between the hemoglobin values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells.
measure: Other markers of severe hemorrhage
time frame: 2 days
description: Mean difference between the hematocrit values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells
.
measure: Other markers of severe hemorrhage
time frame: 2 days
description: Total calculated peripartum blood loss
.
measure: Other markers of severe hemorrhage
time frame: 2 days
description: Proportion of women with a total calculated peripartum blood loss ≥ 1500 mL
.
measure: Other markers of severe hemorrhage
time frame: 2 days
description: Proportion of women transferred to Intensive care unit
measure: Other markers of severe hemorrhage
time frame: 1 day
description: Proportion of women who had invasive second line therapy, any of the following : arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy
measure: other Genital tract infection
time frame: 8 days
description: Assessed by :
Proportion of women with a temperature >38°5C during postpartum hospitalization
measure: other Genital tract infection
time frame: 8 days
description: Assessed by :
Proportion of women with endometritis during postpartum hospitalization.
measure: other Genital tract infection
time frame: 6 weeks
description: Assessed by :
• Proportion of women who had endometritis at the 6 weeks postpartum visit.
measure: Other markers of severe hemorrhage
time frame: 24 hours
description: Proportion of women with a total blood loss in the first 24 hours postpartum ≥ 2000 mL (estimated or measured)
measure: Other markers of severe hemorrhage
time frame: 2 days
description: Proportion of women with a total calculated peripartum blood loss ≥ 2000 mL
arm group label: Early Belfort-Dildy balloon device
arm group type: Experimental
arm group label: Late Belfort-Dildy balloon device
arm group type: Other
intervention type: Device
intervention name: Early Belfort-Dildy Balloon
description: Intrauterine tamponade with the Belfort-Dildy balloon, performed in the 15 minutes after randomization at the same time as the second line uterotonic treatment.
arm group label: Early Belfort-Dildy balloon device
intervention type: Device
intervention name: Late Belfort-Dildy balloon
description: Intrauterine tamponade with the Belfort-Dildy balloon, performed if failure of second line uterotonic treatment, ie persisting bleeding 30 minutes after the beginning of this infusion.
arm group label: Late Belfort-Dildy balloon device
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick ROZENBERG, MD
role: Principal Investigator
affiliation: Department of Obstetrics, Poissy-Saint Germain Hospital Center
last name: Catherine DENEUX - THARAUX, MD, PhD
role: Study Director
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
facility: 
country: France
citation: Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage. Am J Obstet Gynecol. 2012 Oct;207(4):281.e1-7. doi: 10.1016/j.ajog.2012.08.028. Epub 2012 Aug 17.
PMID: 23021688
citation: Georgiou C. Balloon tamponade in the management of postpartum haemorrhage: a review. BJOG. 2009 May;116(6):748-57. doi: 10.1111/j.1471-0528.2009.02113.x.
PMID: 19432563
citation: Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):5-14. doi: 10.1111/j.1471-0528.2012.03454.x. Epub 2012 Aug 13.
PMID: 22882240
citation: Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG. 2017 Jul;124(8):1255-1262. doi: 10.1111/1471-0528.14382. Epub 2016 Oct 25.
PMID: 27781401
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: No