Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section

Placenta Previa Clinical Trial

Official title:

Clinical Outcomes of Combined Bilateral Uterine Artery Ligation and Bakri Balloon Tamponade During Cesarean Section in Patients With Placenta Previa: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518150
• Other study ID #: aswu/270/9/18
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2020
• Source: Aswan University Hospital
• Contact: hany f Sallam, md
• Phone: +20102435461
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Previa

Intervention

Device:
• Bakri balloon
the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally

Procedure:
• Bilateral Uterine Artery Ligation
The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean Blood loss after placental separation	by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set	30 minutes
Secondary	The number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	24 hours
Secondary	Number of Participants with postpartum hemorrhage	number pf participants with blood loss > 1000ml	24 hours