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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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ClinicalTrials.gov Identifier: NCT03891082
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

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.


Condition or disease Intervention/treatment Phase
Post Partum Hemorrhage Procedure: B-Lynch Procedure: BALLOON INSERTION Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.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.
Procedure: 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

Active Comparator: Bakri balloon
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.
Procedure: 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.
Other Name: Bakri balloon:




Primary Outcome Measures :
  1. Estimation of blood loss: [ Time Frame: during the operation ]
    number of saturated pads + amount in suction container (if used) + visualization by the operating team.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891082


Contacts
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Contact: Ahmed Maged, MD +201005227404 prof.ahmedmaged@gmail.com
Contact: Mohamed Elmahy, MD 01111831716 Mohamed.elmahy@kasralainy.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged Professor

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Responsible Party: Ahmed M Maged, MD, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03891082     History of Changes
Other Study ID Numbers: 52
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage