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Uterine Tamponade for Treatment of Primary Postpartum Hemorrhage

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Celox group
Bakri Balloon
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

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

Inclusion Criteria:

  1. Women who accept to participate (either the patient or her first-kin if she is unconscious)
  2. Primary atonic postpartum hemorrhage

Exclusion Criteria:

1. Traumatic postpartum haemorrhage

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Celox group

    Bakri balloon group

    Arm Description

    Celox placement is very simpe . During cesarean section celox is loaded in the lower uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs after vaginal delivery the celox is inserted through the cervix to pack the lower uterine segment. Removal of Celox after 24 hours.

    Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter. Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance; making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe.

    Outcomes

    Primary Outcome Measures

    Amount of blood loss (mL)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2015
    Last Updated
    August 10, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02568657
    Brief Title
    Uterine Tamponade for Treatment of Primary Postpartum Hemorrhage
    Official Title
    Comparison Between Celox Versus Bakri Balloon for Treatment of Primary Atonic Postpartum Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (Actual)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    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
    No

    5. Study Description

    Brief Summary
    Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries. Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should be considered a PPH. In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included Uterine balloon tamponade as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012. In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH. The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings. One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox. Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin .
    Detailed Description
    Balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings. One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox. Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin. We will be having two groups: Celox group: Celox placement is very simpe . During cesarean section celox is loaded in the lower uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs after vaginal delivery the celox is inserted through the cervix to pack the lower uterine segment. Removal of Celox after 24 hours. Bakri balloon group: Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter. Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance; making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Celox group
    Arm Type
    Active Comparator
    Arm Description
    Celox placement is very simpe . During cesarean section celox is loaded in the lower uterine segment and part of it is passed through the cervix to the vagina. If PPH occurs after vaginal delivery the celox is inserted through the cervix to pack the lower uterine segment. Removal of Celox after 24 hours.
    Arm Title
    Bakri balloon group
    Arm Type
    Active Comparator
    Arm Description
    Before insertion the balloon, ensure that the bladder is empty by placing a Foley catheter. Grasp the cervix with ring forceps. Insert the balloon into the cavity of the uterus under ultrasound guidance; making sure that the entire portion of the balloon passes the cervical canal above the internal cervical os. Once the correct placement is confirmed, inflate the balloon with sterile saline using the enclosed syringe.
    Intervention Type
    Device
    Intervention Name(s)
    Celox group
    Intervention Type
    Device
    Intervention Name(s)
    Bakri Balloon
    Primary Outcome Measure Information:
    Title
    Amount of blood loss (mL)
    Time Frame
    8 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women who accept to participate (either the patient or her first-kin if she is unconscious) Primary atonic postpartum hemorrhage Exclusion Criteria: 1. Traumatic postpartum haemorrhage

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32609374
    Citation
    Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
    Results Reference
    derived

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    Uterine Tamponade for Treatment of Primary Postpartum Hemorrhage

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