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A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section

Primary Purpose

Post Partum Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
B-Lynch
BALLOON INSERTION
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Hemorrhage

Eligibility Criteria

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

Inclusion Criteria:

  • Patient undergoing caesarean sections landing up in atonic PPH during LSCS with failure of medical line of management:

    1. Full term pregnancy
    2. Didn't complete her family
    3. Elective caesarian section

Exclusion Criteria:

  • 1.) PPH after vaginal delivery 2.) Secondary PPH 3.) PPH due to causes other than atonicity 4.) Antepartum hemorrhage cases 5.) Patients with bleeding tendency 6.) If any complication occurred during caesarian section (e.g. bladder injury, DIC)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    B-Lynch

    Bakri balloon

    Arm Description

    A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border.The absorbable suture is fed posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point.

    Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium.

    Outcomes

    Primary Outcome Measures

    Estimation of blood loss:
    number of saturated pads + amount in suction container (if used) + visualization by the operating team.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2019
    Last Updated
    March 25, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03891082
    Brief Title
    A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section
    Official Title
    A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo 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
    Hundred (100) patients with primary postpartum hemorrhage during caesarean section due to atonic uterus will be recruited for this study.and randomized to either B lynch or Bakeri Ballon B-Lynch: A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border (because the uterus widens from below upwards). The absorbable suture now visible is passed over to compress the uterine fundus approximately 34 cm from the right cornual border. The absorbable suture is fed posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point. The absorbable suture is pulled under moderate tension assisted by manual compression exerted by the first assistant. The length of the absorbable suture is passed back posteriorly through the same surface marking as for the right side, the suture lying horizontally. The absorbable suture is fed through posteriorly and vertically over the fundus to lie anteriorly and Research Template 7 Final Version: 1/6/2018 vertically compressing the fundus on the left side as occurred on the right. The needle is passed in the same fashion on the left side through the uterine cavity and out approximately 3 cm anteriorly and below the lower incision margin on the left side. The two lengths of absorbable suture are pulled taught assisted by bi-manual compression to minimize trauma and to achieve or aid compression. During such compression the vagina is checked that the bleeding is controlled. As good hemostasis is secured and whilst the uterus is compressed by an experienced assistant the principal surgeon throws a knot (double throw) followed by two or three further throws to secure tension. The lower transverse uterine incision is now closed in the normal way, in two layers, with or without closure of the lower uterine segment peritoneum. BALLOON INSERTION Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium. NOTE: Avoid excessive force when inserting the balloon into the uterus. Place a Foley catheter in patient bladder to collect and monitor urine output. To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.
    Detailed Description
    Hundred (100) patients with primary postpartum hemorrhage during caesarean section due to atonic uterus will be recruited for this study.and randomized to either B lynch or Bakeri Ballon B-Lynch: A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border (because the uterus widens from below upwards). The absorbable suture now visible is passed over to compress the uterine fundus approximately 34 cm from the right cornual border. The absorbable suture is fed posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point. The absorbable suture is pulled under moderate tension assisted by manual compression exerted by the first assistant. The length of the absorbable suture is passed back posteriorly through the same surface marking as for the right side, the suture lying horizontally. The absorbable suture is fed through posteriorly and vertically over the fundus to lie anteriorly and Research Template 7 Final Version: 1/6/2018 vertically compressing the fundus on the left side as occurred on the right. The needle is passed in the same fashion on the left side through the uterine cavity and out approximately 3 cm anteriorly and below the lower incision margin on the left side. The two lengths of absorbable suture are pulled taught assisted by bi-manual compression to minimize trauma and to achieve or aid compression. During such compression the vagina is checked that the bleeding is controlled. As good hemostasis is secured and whilst the uterus is compressed by an experienced assistant the principal surgeon throws a knot (double throw) followed by two or three further throws to secure tension. The lower transverse uterine incision is now closed in the normal way, in two layers, with or without closure of the lower uterine segment peritoneum. BALLOON INSERTION Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium. NOTE: Avoid excessive force when inserting the balloon into the uterus. Place a Foley catheter in patient bladder to collect and monitor urine output. To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    B-Lynch
    Arm Type
    Active Comparator
    Arm Description
    A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border.The absorbable suture is fed posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point.
    Arm Title
    Bakri balloon
    Arm Type
    Active Comparator
    Arm Description
    Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium.
    Intervention Type
    Procedure
    Intervention Name(s)
    B-Lynch
    Intervention Description
    A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border
    Intervention Type
    Procedure
    Intervention Name(s)
    BALLOON INSERTION
    Other Intervention Name(s)
    Bakri balloon:
    Intervention Description
    Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium. NOTE: Avoid excessive force when inserting the balloon into the uterus. Place a Foley catheter in patient bladder to collect and monitor urine output. To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.
    Primary Outcome Measure Information:
    Title
    Estimation of blood loss:
    Description
    number of saturated pads + amount in suction container (if used) + visualization by the operating team.
    Time Frame
    during the operation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient undergoing caesarean sections landing up in atonic PPH during LSCS with failure of medical line of management: Full term pregnancy Didn't complete her family Elective caesarian section Exclusion Criteria: 1.) PPH after vaginal delivery 2.) Secondary PPH 3.) PPH due to causes other than atonicity 4.) Antepartum hemorrhage cases 5.) Patients with bleeding tendency 6.) If any complication occurred during caesarian section (e.g. bladder injury, DIC)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Maged, MD
    Phone
    +201005227404
    Email
    prof.ahmedmaged@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Elmahy, MD
    Phone
    01111831716
    Email
    Mohamed.elmahy@kasralainy.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Maged
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    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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    A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section

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