Bakri Balloon in Placenta Previa

NCT02694341 | Withdrawn

• 1 other identifier: BB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Placenta Previa

Keywords

Management

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Study Arms (2)

Bakri Balloon with abdominal traction stitch

ACTIVE COMPARATOR

bakri balloon will be inserted with abdominal traction stitch

Procedure: Abdominal traction stitch; Device: Bakri Balloon

Bakri Balloon without abdominal traction stitch

EXPERIMENTAL

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

Device: Bakri Balloon

Interventions

Abdominal traction stitch PROCEDURE

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 with abdominal traction stitch

Bakri Balloon DEVICE

uterine compression balloon

Bakri Balloon with abdominal traction stitch; Bakri Balloon without abdominal traction stitch

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All women delivered and presented with primary atonic PPH
• Women who accepted to participate

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32609374 DERIVED

MeSH Terms

Conditions

Hemorrhage; Placenta Previa

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: February 29, 2016
• Study Start: December 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)