Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins

Cesarean Section Complications Clinical Trial

Official title:

Clinical Outcomes of Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518176
• Other study ID #: aswu/279/8/18
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 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

Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy

Description:

A randomized clinical trial at Aswan University Maternity Hospital, Egypt. Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups. In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL. The primary outcome was the estimated blood loss during a cesarean

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• women undergoing cesarean section

• twin pregnancy

Exclusion Criteria:

• Placenta previa.

• Ante-partum hemorrhage.

• patient refuse to participate

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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

Drug:
• Oxytocin
20 units by slow intravenous drip injection

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	Number of Participants with postpartum hemorrhage	number pf participants with blood loss > 1000ml	12 hours
Secondary	The number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	24 hours