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PDIUC Protocol for Placental Accreta (PDIUC)

Primary Purpose

Placenta Accreta

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PDI-UC protocol
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Accreta

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with diagnosis of placenta accreta (US or MRI based diagnosis)
  • Women who decline hysterectomy
  • Pregnancy at 28 weeks of gestation or beyond
  • Women who accept to participate in the study

Exclusion Criteria:

  • Emergency Cesarean delivery (women with active bleeding)
  • Women with cardiac diseases
  • Women with coagulopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Women with placenta accreta

    Arm Description

    PDI-UC protocol

    Outcomes

    Primary Outcome Measures

    Uterine conservation
    Successive Uterine conservation; no peripartum hysterectomy needed

    Secondary Outcome Measures

    Primary postpartum hemorrhage
    Amount of postpartum bleeding > 1000 ml
    Severe primary postpartum hemorrhage
    Amount of postpartum bleeding > 1500 ml
    Bladder injury
    Incidental injury of the bladder during delivery of the placenta or control of bleeding
    Bowel injury
    Incidental injury of the bladder during delivery of the placenta or control of bleeding
    Surgical site infection
    Cesarean wound infection
    Drop in hemoglobin level
    Change in hemoglobin before and more than 24 hours after delivery

    Full Information

    First Posted
    August 5, 2017
    Last Updated
    September 4, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03273569
    Brief Title
    PDIUC Protocol for Placental Accreta
    Acronym
    PDIUC
    Official Title
    Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2017 (Anticipated)
    Primary Completion Date
    March 30, 2018 (Anticipated)
    Study Completion Date
    June 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.
    Detailed Description
    Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Women with placenta accreta at the time of Cesarean delivery
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Women with placenta accreta
    Arm Type
    Experimental
    Arm Description
    PDI-UC protocol
    Intervention Type
    Procedure
    Intervention Name(s)
    PDI-UC protocol
    Intervention Description
    Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed
    Primary Outcome Measure Information:
    Title
    Uterine conservation
    Description
    Successive Uterine conservation; no peripartum hysterectomy needed
    Time Frame
    Intra-operative (during the time of Cesarean delivery)
    Secondary Outcome Measure Information:
    Title
    Primary postpartum hemorrhage
    Description
    Amount of postpartum bleeding > 1000 ml
    Time Frame
    From delivery of the fetus to 1 hour after delivery of the fetus
    Title
    Severe primary postpartum hemorrhage
    Description
    Amount of postpartum bleeding > 1500 ml
    Time Frame
    From delivery of the fetus to 1 hour after delivery of the fetus
    Title
    Bladder injury
    Description
    Incidental injury of the bladder during delivery of the placenta or control of bleeding
    Time Frame
    Intra-operative (during the time of Cesarean delivery)
    Title
    Bowel injury
    Description
    Incidental injury of the bladder during delivery of the placenta or control of bleeding
    Time Frame
    Intra-operative (during the time of Cesarean delivery)
    Title
    Surgical site infection
    Description
    Cesarean wound infection
    Time Frame
    Up to 2 weeks after Cesarean delivery
    Title
    Drop in hemoglobin level
    Description
    Change in hemoglobin before and more than 24 hours after delivery
    Time Frame
    Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women with diagnosis of placenta accreta (US or MRI based diagnosis) Women who decline hysterectomy Pregnancy at 28 weeks of gestation or beyond Women who accept to participate in the study Exclusion Criteria: Emergency Cesarean delivery (women with active bleeding) Women with cardiac diseases Women with coagulopathy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sherif Shazly, MBBCh, MSc
    Phone
    +15075131392
    Email
    sherify2k2@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abbas, MBBCh, MD
    Phone
    +201003385183
    Email
    bmr90@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    PDIUC Protocol for Placental Accreta

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