NCT07446933

Vasopressin vs. Uterine Artery Clamping for Laparoscopic Cesarean Scar Niche Repair

Noninferiority of Intramyometrial Vasopressin Injection Compared to Bilateral Temporary Clamping of Uterine Arteries During Laparoscopic Excision and Repair of Cesarean Scar Niche

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN). It compares the effectiveness of intramyometrial vasopressin injection against bilateral temporary clamping of the uterine arteries using laparoscopic bulldog clips. The goal is to determine if vasopressin injection is non-inferior to arterial clamping in reducing blood loss and maintaining surgical field visibility.

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Vasopressin Group	Patients receive a local injection of 12 mL of diluted vasopressin into the myometrium directly surrounding the cesarean scar niche. This is performed during the laparoscopic procedure, just before the excision of the fibrous scar tissue, to constrict local blood vessels and minimize intraoperative bleeding.
PROCEDURE	Bulldog Clamping Group	This intervention involves the temporary mechanical clamping of both uterine arteries using laparoscopic bulldog vascular clips. The clips are applied to block blood flow to the uterus before the niche is excised and are removed once the myometrial reconstruction is complete.
PROCEDURE	Standard of Care	Approach: A 3-port laparoscopic approach using Storz endoscopic instruments. Excision: Complete removal of the fibrous scar tissue surrounding the niche defect. Reconstruction: Suturing and repair of the myometrium to resolve the defect.

Timeline

• Start date: 2024-03-20
• Primary completion: 2025-10-17
• Completion: 2026-01-15
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Saudi Arabia