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Withdrawn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
About this trial
This is an interventional treatment trial for Bleeding focused on measuring Management
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.
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
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Withdrawn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
We'll reach out to this number within 24 hrs