<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/NCT04423263</url>
  </required_header>
  <id_info>
    <org_study_id>Research ID 55302</org_study_id>
    <nct_id>NCT04423263</nct_id>
  </id_info>
  <brief_title>Internal Iliac Artery Occlusion in Placenta Accreta</brief_title>
  <official_title>Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Voon Hian Yan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sarawak General Hospital</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized study to assess the efficacy of prophylactic bilateral internal iliac&#xD;
      artery occlusion performed prior to planned surgical management for placenta accreta spectrum&#xD;
      (PAS). The intervention group would receive balloon occlusion, ureteric stenting and&#xD;
      caesaeran hysterectomy while the control group would undergo the same procedure, excluding&#xD;
      balloon occlusion. The primary outcome is to demonstrate a three pint or greater reduction in&#xD;
      pack cell transfusion requirement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventional radiology, including internal iliac artery occlusion, has been used as an&#xD;
      adjunct in the management of placenta accreta spectrum (PAS). Retrospective studies have&#xD;
      shown benefit in terms of reduction of blood loss. However, studies reported in literature&#xD;
      vary widely in terms of the exact surgical procedure undertaken, in conjunction with the&#xD;
      radiological intervention. The radiological intervention itself lacks standardization,&#xD;
      occurring at different anatomical levels, ranging from infrarenal aortic occlusion to&#xD;
      internal iliac or uterine artery. Furthermore, there have been reported cases of arterial&#xD;
      thrombosis associated with arterial occlusion.&#xD;
&#xD;
      We sought to clarify the effectiveness of a standardized approach , where perioperative&#xD;
      bilateral internal iliac artery occlusion is performed followed by bilateral ureteric&#xD;
      stenting and caesarean hysterectomy. The control group would undergo the exact procedure,&#xD;
      excluding internal iliac artery occlusion. Patients would be randomized but neither the&#xD;
      patient nor surgeon could be blinded.&#xD;
&#xD;
      The primary outcome would be to demonstrate a three pint or greater reduction in packed cell&#xD;
      transfusion. Secondary outcomes include a difference in estimated blood loss, additional&#xD;
      blood product transfusion, unplanned additional surgical procedure, serious complications&#xD;
      arising from internal iliac artery occlusion, total procedural time and early neonatal&#xD;
      outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 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>Pack cell transfusion</measure>
    <time_frame>First 7 days post-operatively</time_frame>
    <description>To detect a three pint reduction in pack cell transfusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other blood components</measure>
    <time_frame>First 7 days post-operatively</time_frame>
    <description>Platelets, fresh fozen plasma, cryoprecipitate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned perioperative surgical procedures</measure>
    <time_frame>First 7 days post-operatively</time_frame>
    <description>Internal iliac artery ligation, abdominal packing, relaparotomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication from internal iliac occlusion</measure>
    <time_frame>First 14 days post-operatively</time_frame>
    <description>death, arterial thrombosis, aneurysm, hematoma requiring evacuation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Operative time</measure>
    <time_frame>Perioperative</time_frame>
    <description>Total time taken for procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal complication</measure>
    <time_frame>First 24 hours</time_frame>
    <description>Apgar, cord pH, resuscitation, neonatal intensive care admission</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Placenta Accreta</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives bilateral internal iliac artery occlusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Does not receive bilateral internal iliac artery occlusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral internal iliac artery balloon occlusion</intervention_name>
    <description>Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pregnant women with prenatally diagnosed placenta accreta spectrum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who declined to participate&#xD;
&#xD;
          -  Women with bleeding diathesis or severe thrombocytopenia &lt;100k x 1,000,000/L&#xD;
&#xD;
          -  Surgery performed prior to 28 weeks of gestation&#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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hian Yan Voon, MRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sarawak General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hian Yan Voon, MRCOG</last_name>
    <phone>+6082 276666</phone>
    <email>vhaxyn@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Chen M, Liu X, You Y, Wang X, Li T, Luo H, Qu H, Xu L. Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1112-1119. doi: 10.1097/AOG.0000000000003792.</citation>
    <PMID>32282608</PMID>
  </reference>
  <reference>
    <citation>Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.</citation>
    <PMID>26444128</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sarawak General Hospital</investigator_affiliation>
    <investigator_full_name>Voon Hian Yan</investigator_full_name>
    <investigator_title>Consultant Maternal Fetal Medicine Specialist</investigator_title>
  </responsible_party>
  <keyword>balloon occlusion</keyword>
  <keyword>iliac artery</keyword>
  <keyword>interventional radiology</keyword>
  <keyword>postpartum hemorrhage</keyword>
  <keyword>blood transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Accreta</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study protocol and anonymized information including demographics, primary and secondary outcomes</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>36 months from the date of completion of study</ipd_time_frame>
    <ipd_access_criteria>Written permission to authors and submission of complete protocol</ipd_access_criteria>
  </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/NCT04423263
org study id: Research ID 55302
nct id: NCT04423263
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This is a randomized study to assess the efficacy of prophylactic bilateral internal iliac
      artery occlusion performed prior to planned surgical management for placenta accreta spectrum
      (PAS). The intervention group would receive balloon occlusion, ureteric stenting and
      caesaeran hysterectomy while the control group would undergo the same procedure, excluding
      balloon occlusion. The primary outcome is to demonstrate a three pint or greater reduction in
      pack cell transfusion requirement.
Interventional radiology, including internal iliac artery occlusion, has been used as an
      adjunct in the management of placenta accreta spectrum (PAS). Retrospective studies have
      shown benefit in terms of reduction of blood loss. However, studies reported in literature
      vary widely in terms of the exact surgical procedure undertaken, in conjunction with the
      radiological intervention. The radiological intervention itself lacks standardization,
      occurring at different anatomical levels, ranging from infrarenal aortic occlusion to
      internal iliac or uterine artery. Furthermore, there have been reported cases of arterial
      thrombosis associated with arterial occlusion.

      We sought to clarify the effectiveness of a standardized approach , where perioperative
      bilateral internal iliac artery occlusion is performed followed by bilateral ureteric
      stenting and caesarean hysterectomy. The control group would undergo the exact procedure,
      excluding internal iliac artery occlusion. Patients would be randomized but neither the
      patient nor surgeon could be blinded.

      The primary outcome would be to demonstrate a three pint or greater reduction in packed cell
      transfusion. Secondary outcomes include a difference in estimated blood loss, additional
      blood product transfusion, unplanned additional surgical procedure, serious complications
      arising from internal iliac artery occlusion, total procedural time and early neonatal
      outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pack cell transfusion
time frame: First 7 days post-operatively
description: To detect a three pint reduction in pack cell transfusion
measure: Other blood components
time frame: First 7 days post-operatively
description: Platelets, fresh fozen plasma, cryoprecipitate
measure: Unplanned perioperative surgical procedures
time frame: First 7 days post-operatively
description: Internal iliac artery ligation, abdominal packing, relaparotomy
measure: Complication from internal iliac occlusion
time frame: First 14 days post-operatively
description: death, arterial thrombosis, aneurysm, hematoma requiring evacuation
measure: Operative time
time frame: Perioperative
description: Total time taken for procedure
measure: Neonatal complication
time frame: First 24 hours
description: Apgar, cord pH, resuscitation, neonatal intensive care admission
arm group label: Intervention
arm group type: Experimental
description: Receives bilateral internal iliac artery occlusion
arm group label: Control
arm group type: Active Comparator
description: Does not receive bilateral internal iliac artery occlusion
intervention type: Procedure
intervention name: Bilateral internal iliac artery balloon occlusion
description: Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
arm group label: Intervention
intervention type: Procedure
intervention name: Control
description: Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion
arm group label: Control
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hian Yan Voon, MRCOG
role: Principal Investigator
affiliation: Sarawak General Hospital
last name: Hian Yan Voon, MRCOG
phone: +6082 276666
email: vhaxyn@gmail.com
citation: Chen M, Liu X, You Y, Wang X, Li T, Luo H, Qu H, Xu L. Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1112-1119. doi: 10.1097/AOG.0000000000003792.
PMID: 32282608
citation: Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.
PMID: 26444128
responsible party type: Sponsor-Investigator
investigator affiliation: Sarawak General Hospital
investigator full name: Voon Hian Yan
investigator title: Consultant Maternal Fetal Medicine Specialist
mesh term: Placenta Accreta
sharing ipd: Yes
ipd description: Study protocol and anonymized information including demographics, primary and secondary outcomes
ipd info type: Study Protocol
ipd time frame: 36 months from the date of completion of study
ipd access criteria: Written permission to authors and submission of complete protocol