Bakri Balloon in Placenta Previa (BB-ATS)

May 26, 2020 updated by: Ahmed Mohamed Abbas, Assiut University

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

The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bakri Balloon with abdominal traction stitch
bakri balloon will be inserted with abdominal traction stitch
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
Experimental: Bakri Balloon without abdominal traction stitch
bakri balloon will be inserted with no performance of abdominal traction stitch
Device: Bakri Balloon
uterine compression balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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