Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02694341

Bakri Balloon in Placenta Previa

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREAbdominal traction stitchAbdominal 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.
DEVICEBakri Balloonuterine compression balloon

Timeline

Start date
2018-12-01
Primary completion
2019-11-01
Completion
2019-12-01
First posted
2016-02-29
Last updated
2020-05-28

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02694341. Inclusion in this directory is not an endorsement.