Reproductive Outcomes Following Uterine Septum Resection

Completed

• Conditions: Uterine Septum

• Registration Number: NCT05139446
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data.

A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points.

Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births).

The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-05-02
• Study Completion: 2021-07-02
• Status Verified: 2021-10
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-12-01
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retrospective study of the uterine septum resection technique by operative hysteroscopy	Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined]

Trial Locations

Locations (1)

Service de Gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France