Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section

Aswan University Hospital

Status: Unknown

Conditions: Placenta Previa

Treatments: Procedure: Bilateral Uterine Artery Ligation; Device: Bakri balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT04518150

aswu/270/9/18

Details and patient eligibility

About

This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa

Full description

Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion criteria

• patients with the high possibility of morbid adherent placenta
• those presented with severe antepartum hemorrhage
• Patients with cardiac, hepatic, renal, or thromboembolic disease;
• patient refuses to consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

study group

Experimental group

Description:

patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon

Treatment:

Device: Bakri balloon

Procedure: Bilateral Uterine Artery Ligation

control group

Active Comparator group

Description:

patients with placenta previa undergoing cesarean section underwent insertion of Bakri balloon

Treatment:

Device: Bakri balloon