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Internal Iliac Artery Occlusion in Placenta Accreta

Primary Purpose

Placenta Accreta

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral internal iliac artery balloon occlusion
Control
Sponsored by
Voon Hian Yan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta Accreta focused on measuring balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All pregnant women with prenatally diagnosed placenta accreta spectrum

Exclusion Criteria:

  • Women who declined to participate
  • Women with bleeding diathesis or severe thrombocytopenia <100k x 1,000,000/L
  • Surgery performed prior to 28 weeks of gestation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Receives bilateral internal iliac artery occlusion

    Does not receive bilateral internal iliac artery occlusion

    Outcomes

    Primary Outcome Measures

    Pack cell transfusion
    To detect a three pint reduction in pack cell transfusion

    Secondary Outcome Measures

    Other blood components
    Platelets, fresh fozen plasma, cryoprecipitate
    Unplanned perioperative surgical procedures
    Internal iliac artery ligation, abdominal packing, relaparotomy
    Complication from internal iliac occlusion
    death, arterial thrombosis, aneurysm, hematoma requiring evacuation

    Full Information

    First Posted
    June 5, 2020
    Last Updated
    June 5, 2020
    Sponsor
    Voon Hian Yan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04423263
    Brief Title
    Internal Iliac Artery Occlusion in Placenta Accreta
    Official Title
    Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Voon Hian Yan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Accreta
    Keywords
    balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Receives bilateral internal iliac artery occlusion
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Does not receive bilateral internal iliac artery occlusion
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral internal iliac artery balloon occlusion
    Intervention Description
    Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
    Intervention Type
    Procedure
    Intervention Name(s)
    Control
    Intervention Description
    Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion
    Primary Outcome Measure Information:
    Title
    Pack cell transfusion
    Description
    To detect a three pint reduction in pack cell transfusion
    Time Frame
    First 7 days post-operatively
    Secondary Outcome Measure Information:
    Title
    Other blood components
    Description
    Platelets, fresh fozen plasma, cryoprecipitate
    Time Frame
    First 7 days post-operatively
    Title
    Unplanned perioperative surgical procedures
    Description
    Internal iliac artery ligation, abdominal packing, relaparotomy
    Time Frame
    First 7 days post-operatively
    Title
    Complication from internal iliac occlusion
    Description
    death, arterial thrombosis, aneurysm, hematoma requiring evacuation
    Time Frame
    First 14 days post-operatively
    Other Pre-specified Outcome Measures:
    Title
    Operative time
    Description
    Total time taken for procedure
    Time Frame
    Perioperative
    Title
    Neonatal complication
    Description
    Apgar, cord pH, resuscitation, neonatal intensive care admission
    Time Frame
    First 24 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All pregnant women with prenatally diagnosed placenta accreta spectrum Exclusion Criteria: Women who declined to participate Women with bleeding diathesis or severe thrombocytopenia <100k x 1,000,000/L Surgery performed prior to 28 weeks of gestation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hian Yan Voon, MRCOG
    Phone
    +6082 276666
    Email
    vhaxyn@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hian Yan Voon, MRCOG
    Organizational Affiliation
    Sarawak General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study protocol and anonymized information including demographics, primary and secondary outcomes
    IPD Sharing Time Frame
    36 months from the date of completion of study
    IPD Sharing Access Criteria
    Written permission to authors and submission of complete protocol
    Citations:
    PubMed Identifier
    32282608
    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.
    Results Reference
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    PubMed Identifier
    26444128
    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.
    Results Reference
    background

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    Internal Iliac Artery Occlusion in Placenta Accreta

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