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Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta

Primary Purpose

Placenta Previa, Placenta Accreta

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prophylactic internal iliac artery balloon catheterization
Prophylactic internal iliac artery balloon
Radiology operation
Sponsored by
Deng Dongrui
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta Previa

Eligibility Criteria

15 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging.

Exclusion Criteria:

  • Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Balloon group

    Control group

    Arm Description

    Prophylactic Internal Iliac Artery Balloon Catheterization

    no intervention

    Outcomes

    Primary Outcome Measures

    blood loss

    Secondary Outcome Measures

    operation duration
    fluid transfusion
    blood transfusion

    Full Information

    First Posted
    November 15, 2016
    Last Updated
    November 16, 2016
    Sponsor
    Deng Dongrui
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02966197
    Brief Title
    Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
    Official Title
    the Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Deng Dongrui

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.
    Detailed Description
    Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta. Between June 2015 and August 2016,patients were personally recruited and managed by the authors,and assigned to either balloon group or control group by their willingness to catheterization or not. Both groups benefitted similar management protocol with the exception of interventional radiology operation. Intraoperative blood loss, transfusion volume, radiation dose, exposure time, surgical duration, procedure complications and neonatal outcomes were analyzed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Previa, Placenta Accreta

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Balloon group
    Arm Type
    Experimental
    Arm Description
    Prophylactic Internal Iliac Artery Balloon Catheterization
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    no intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    prophylactic internal iliac artery balloon catheterization
    Intervention Description
    Between June 2015 and August 2016
    Intervention Type
    Device
    Intervention Name(s)
    Prophylactic internal iliac artery balloon
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiology operation
    Primary Outcome Measure Information:
    Title
    blood loss
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    operation duration
    Time Frame
    intraoperative
    Title
    fluid transfusion
    Time Frame
    intraoperative
    Title
    blood transfusion
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging. Exclusion Criteria: Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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