Bakri Balloon in Placenta Previa (BB-ATS)

Assiut University

Status: Withdrawn

Conditions: Placenta Previa; Bleeding

Treatments: Procedure: Abdominal traction stitch; Device: Bakri Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02694341

BB

Details and patient eligibility

About

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

Sex: Female

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Bakri Balloon with abdominal traction stitch

Active Comparator group

Description:

bakri balloon will be inserted with abdominal traction stitch

Treatment:

Procedure: Abdominal traction stitch

Device: Bakri Balloon

Bakri Balloon without abdominal traction stitch

Experimental group

Description:

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

Treatment:

Device: Bakri Balloon