Status
Completed
Phase
Phase 2
Enrollment
30
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
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.
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.
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.
Timeline
First posted
Mar 3, 2026
Study start
Mar 20, 2024
Primary completion
Oct 17, 2025
Study completion
Jan 15, 2026
Results posted
Not reported
Registry updated
Mar 3, 2026
Outcomes
Mean Hemoglobin Deficit Mean Hemoglobin Deficit
Time frame · 24 hours post-surgery.
The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.
Surgical Field Visibility (SFV) Score
Time frame · Intraoperative
Assessment of the clarity of the surgical field using Boezaart's scale (0-5), where lower scores indicate better visibility.
Total Operative Time
Time frame · Intraoperative
Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.
Eligibility
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 locations
Saudi Arabia. Showing up to 24 locations stored in the fast local snapshot.
Dr. Samir Abbas Hospital
Jeddah, Saudi Arabia
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
First Affiliated Hospital, Sun Yat-Sen University · Liver Neoplasms · Postoperative Complications
Not applicable
Completed
161
2026-07
Montefiore Medical Center · Cervical Preparation
Phase 1
Recruiting
94
2026-07
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Zhaoyun Zhang · Craniopharyngiomas · Pituitary Macroadenoma
Phase 4
Enrolling by invitation
152
2026-07
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremias · Water Intoxication
Phase 3
Completed
205
2026-07
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremia
Phase 3
Completed
243
2026-07
Beijing Friendship Hospital · Kidney Transplant · Delayed Graft Function
Not applicable
Active, not recruiting
150
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.