Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section

Not Applicable

• Conditions: Placenta Previa
• Interventions: Device: Bakri balloon; Procedure: Bilateral Uterine Artery Ligation

• Registration Number: NCT04518150
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-08-15
• Study First Posted: 2020-08-19
• Status Verified: 2020-09
• Study Start: 2020-09-01
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-21
• Primary Completion: 2022-08-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Bilateral Uterine Artery Ligation	patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon
study group	Bakri balloon	patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon
control group	Bakri balloon	patients with placenta previa undergoing cesarean section underwent insertion of Bakri balloon

Primary Outcome Measures

Name	Time	Method
mean Blood loss after placental separation	30 minutes	by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

Secondary Outcome Measures

Name	Time	Method
The number of participant needed for blood transfusion	24 hours	Calculation of the number of participant needed for blood transfusion
Number of Participants with postpartum hemorrhage	24 hours	number pf participants with blood loss \> 1000ml

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt