New Pre-Surgical Scoring System for Uterine Septum

Not Applicable

Recruiting

• Conditions: Septate Uterus
• Interventions: Diagnostic Test: Shawki Septum Scoring System; Diagnostic Test: ESHRE ASRM Classification

• Registration Number: NCT05823103
• Lead Sponsor: Ebtesama Hospital

Brief Summary

Comparing surgical outcomes of Hysteroscopic metroplasty for uterine septum when using the standard ESGE or ASRM classifications vs the novel scoring system dubbed Shawki Septum Scoring System.

Outcomes based primarily on completion of the septal correction (no residual parts) and avoiding complications, the most significant of which are uterine perforation.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-18
• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-08
• Last Update Submitted: 2023-04-08
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Uterine Septum diagnosed by 3D ultrasound

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hysteroscopic Metroplasty using Shawki Septum Scoring System	Shawki Septum Scoring System	-
Hysteroscopic Metroplasty using ESHRE ASRM Classification	ESHRE ASRM Classification	-

Primary Outcome Measures

Name	Time	Method
Number of patients with Complete Septum Correction	1 month	No residual septum on 3D ultrasound
Percentage of patients who had an intra-operative Uterine perforation	during the surgery	Diminishing the risk of intra-operative perforation of the fundus

Trial Locations

Locations (1)

Shifa Hospital; 🇪🇬 Cairo, Egypt