Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-12-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bakri Balloon with abdominal traction stitch
bakri balloon will be inserted with abdominal traction stitch
Abdominal traction stitch
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.
Bakri Balloon
uterine compression balloon
Bakri Balloon without abdominal traction stitch
bakri balloon will be inserted with no performance of abdominal traction stitch
Bakri Balloon
uterine compression balloon
Interventions
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Abdominal traction stitch
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.
Bakri Balloon
uterine compression balloon
Eligibility Criteria
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Inclusion Criteria
2. Women who accepted to participate
Exclusion Criteria
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.
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Mohamed Abbas
Dr
Locations
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Ahmed Abbas
Assiut, Cairo Governorate, Egypt
Countries
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References
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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.
Other Identifiers
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BB
Identifier Type: -
Identifier Source: org_study_id
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