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OpenTrials
Completed

NCT Number: NCT07446933

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

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.

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Key information

Conditions

Cesarean Section Complications

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Samir Abbas Hospital

Jeddah, 23411, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Total Operative Time

    Time frame: Intraoperative

    Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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