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

NCT07446933 | Completed Phase 2

• 1 other identifier: N#3/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Surgical Field Visibility (SFV) Score

  Intraoperative

• Total Operative Time

  Intraoperative

Study Arms (2)

Vasopressin Group (Group V)

ACTIVE COMPARATOR

Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision.

Drug: Vasopressin Group; Procedure: Standard of Care

Uterine Artery Clamping Group (Group B)

ACTIVE COMPARATOR

Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision.

Procedure: Bulldog Clamping Group; Procedure: Standard of Care

Interventions

Vasopressin Group DRUG

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.

Vasopressin Group (Group V)

Bulldog Clamping Group PROCEDURE

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.

Uterine Artery Clamping Group (Group B)

Standard of Care PROCEDURE

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.

Uterine Artery Clamping Group (Group B); Vasopressin Group (Group V)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Dr. Samir Abbas Hospital

Jeddah, 23411, Saudi Arabia

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obestitrics and gynecology

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: March 20, 2024
• Primary Completion: October 17, 2025
• Study Completion: January 15, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

SA (1)