Bakri Balloon in Placenta Previa

Bleeding Clinical Trial

— BB-ATS  

Official title:

Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02694341
• Other study ID #: BB
• Status: Withdrawn
• Phase: N/A
• Start date: December 2018
• Est. completion date: December 2019

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Placenta Previa

Intervention

Procedure:
• 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.

Device:
• Bakri Balloon
uterine compression balloon

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.		24 hours