Bakri Balloon in Placenta Previa

Not Applicable

Withdrawn

• Conditions: Bleeding; Placenta Previa
• Interventions: Procedure: Abdominal traction stitch; Device: Bakri Balloon

• Registration Number: NCT02694341
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-02-29
• Study Start: 2018-12
• Primary Completion: 2019-11
• Study Completion: 2019-12
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bakri Balloon with abdominal traction stitch	Bakri Balloon	bakri balloon will be inserted with abdominal traction stitch
Bakri Balloon without abdominal traction stitch	Bakri Balloon	bakri balloon will be inserted with no performance of abdominal traction stitch
Bakri Balloon with abdominal traction stitch	Abdominal traction stitch	bakri balloon will be inserted with abdominal traction stitch

Primary Outcome Measures

Name	Time	Method
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.	24 hours

Trial Locations

Locations (1)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt