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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Vasopressin Group; Procedure: Standard of Care; Procedure: Bulldog Clamping Group

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 23411
    • Dr. Samir Abbas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosis of symptomatic CSN.
• Scheduled for laparoscopic excision and repair.

Exclusion Criteria:

• Contraindications to vasopressin (e.g., severe hypertension or cardiovascular disease).
• Presence of other major uterine pathologies (e.g., large myomas or malignancy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vasopressin Group (Group V); Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision.	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: 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.
Active Comparator: Uterine Artery Clamping Group (Group B); Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Hemoglobin Deficit Mean Hemoglobin Deficit	The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.	24 hours post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative
Total Operative Time	Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.	Intraoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): October 17, 2025
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: N#3/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No