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Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02694341

Acronym

BB-ATS

Enrollment

Registered

2016-02-29

Start date

2018-12-31

Completion date

2019-12-31

Last updated

2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Placenta Previa

Keywords

Management

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.

Interventions

PROCEDUREAbdominal 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.

DEVICEBakri Balloon

uterine compression balloon

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.	24 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026