Bakri Balloon in Placenta Previa

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

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

Conditions
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Bleeding, Placenta Previa

Intervention / Treatment
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* Procedure: Abdominal traction stitch
* Device: Bakri Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women delivered and presented with primary atonic PPH Women who accepted to participate Exclusion Criteria: 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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bakri Balloon with abdominal traction stitch<br>bakri balloon will be inserted with abdominal traction stitch | Procedure: Abdominal traction stitch<br>* 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.<br>Device: Bakri Balloon<br>* uterine compression balloon<br>|
| Experimental: Bakri Balloon without abdominal traction stitch<br>bakri balloon will be inserted with no performance of abdominal traction stitch | Device: Bakri Balloon<br>* uterine compression balloon<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Management