Reproductive Outcomes Following Uterine Septum Resection

NCT05139446 | Completed

• 1 other identifier: 8070
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Septum

Keywords

uterine septum; Hysteroscopic septum resection; Metroplasty; Subfertility; Infertility; Preterm delivery; Spontaneous abortion

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major female (≥18 years old) being an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.

You may qualify if:

• Major female (≥18 years old) To be an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.

You may not qualify if:

• Particular clinical forms of the disease, (associated enlargement metroplasties, other uterine maformations) Minor patients, patients under guardianship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Septate Uterus; Infertility; Premature Birth; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Uterine Duplication Anomalies; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 1, 2021
• Study Start: January 1, 2020
• Primary Completion: May 2, 2021
• Study Completion: July 2, 2021
• Last Updated: November 3, 2023

Record last verified: 2021-10

Locations

FR (1)