A Phase 2 interventional study of Vasopressin Group and Bulldog Clamping Group in Cesarean Section Complications, sponsored by Zagazig University. Completed at 1 site in Saudi Arabia. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Zagazig University · Phase 2, Interventional, and Treatment
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.
Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision.
Drug: Vasopressin Group · Procedure: Standard of Care
Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision.
Procedure: Bulldog Clamping Group · Procedure: Standard of Care
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.
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.
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.
Mean Hemoglobin Deficit Mean Hemoglobin Deficit
The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.
Time frame: 24 hours post-surgery.
Surgical Field Visibility (SFV) Score
Assessment of the clarity of the surgical field using Boezaart's scale (0-5), where lower scores indicate better visibility.
Time frame: Intraoperative
Total Operative Time
Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.
Time frame: Intraoperative
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Zagazig University