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

Plain-language guide to NCT07446933: phase 2 randomized trial of Vasopressin, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07446933
Phase
phase 2
Status
completed
Start
2024-03-20
Completion (planned or actual)
2025-10-17
Participants
30 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Cesarean Section Complications
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Vasopressin.

This study evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN).

It had two arms (groups): Vasopressin Group (Group V) (active comparator) and Uterine Artery Clamping Group (Group B) (active comparator).

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

The registry classes the interventions as drug and procedure.

Who Took Part

The registry lists 30 actual participants took part.

It was open to women only aged from 21 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Diagnosis of symptomatic CSN. Scheduled for laparoscopic excision and repair.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: contraindications to vasopressin (e.g., severe hypertension or cardiovascular disease); presence of other major uterine pathologies (e.g., large myomas or malignancy).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Vasopressin study: the participants and staff both knew the treatment.

It started in 2024-03-20 with completion listed for 2025-10-17.

It ran at 1 site in Saudi Arabia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Hemoglobin Deficit Mean Hemoglobin Deficit (time frame: 24 hours post-surgery).

It also tracked 2 secondary outcomes, for example Surgical Field Visibility (SFV) Score and Total Operative Time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vasopressin in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.

Our Notes on the Compound

Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.