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Bakri Balloon in Placenta Previa (BB-ATS)

Primary Purpose

Bleeding, Placenta Previa

Status
Withdrawn
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Abdominal traction stitch
Bakri Balloon
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. All women delivered and presented with primary atonic PPH
  2. Women who accepted to participate

Exclusion Criteria:

  1. Traumatic PPH as excluded by examination under anesthesia.
  2. With any suspected or clinical evidence of uterine infection
  3. Women diagnosed to have preeclampsia or eclampsia after delivery.
  4. Women who had DM during pregnancy
  5. Women with history of DVT or other thromboembolic complication
  6. Women with history of rheumatic heart disease.
  7. Women with coagulation defects.

Sites / Locations

  • Ahmed Abbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bakri Balloon with abdominal traction stitch

Bakri Balloon without abdominal traction stitch

Arm Description

bakri balloon will be inserted with abdominal traction stitch

bakri balloon will be inserted with no performance of abdominal traction stitch

Outcomes

Primary Outcome Measures

Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2016
Last Updated
May 26, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02694341
Brief Title
Bakri Balloon in Placenta Previa
Acronym
BB-ATS
Official Title
Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participants shared
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
December 2019 (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
No

5. Study Description

Brief Summary
The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Placenta Previa
Keywords
Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bakri Balloon with abdominal traction stitch
Arm Type
Active Comparator
Arm Description
bakri balloon will be inserted with abdominal traction stitch
Arm Title
Bakri Balloon without abdominal traction stitch
Arm Type
Experimental
Arm Description
bakri balloon will be inserted with no performance of abdominal traction stitch
Intervention Type
Procedure
Intervention Name(s)
Abdominal traction stitch
Intervention Description
Abdominal traction stitch to prevent prolapse of the Bakri balloon. A suture is tied through the uterine end shaft hole of the Bakri balloon. The other end of the suture is placed through the uterine wall. The balloon is positioned in the lower segment.The abdominal traction stitch is held by forceps and fixed, with cephalad traction applied continuously to the balloon, preventing balloon prolapse.The abdominal traction stitch is fixed by an umbilical cord clamp on the abdominal wall, preventing the suture from receding into the abdominal cavity, and, thus, maintaining the correct position of the balloon and preventing prolapse. Removal of the balloon is easy, with no resistance; the suture does not hinder balloon removal. At the time of balloon removal, the suture that was placed through the abdominal wall will traverse the intra-abdominal and intrauterine cavities, and should be kept clean.
Intervention Type
Device
Intervention Name(s)
Bakri Balloon
Intervention Description
uterine compression balloon
Primary Outcome Measure Information:
Title
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.
Time Frame
24 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All women delivered and presented with primary atonic PPH Women who accepted to participate Exclusion Criteria: Traumatic PPH as excluded by examination under anesthesia. With any suspected or clinical evidence of uterine infection Women diagnosed to have preeclampsia or eclampsia after delivery. Women who had DM during pregnancy Women with history of DVT or other thromboembolic complication Women with history of rheumatic heart disease. Women with coagulation defects.
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
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

Learn more about this trial

Bakri Balloon in Placenta Previa

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