Reproductive Outcomes Following Uterine Septum Resection

Uterine Septum Clinical Trial

— UTER-SEPTUM  

Official title:

Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05139446
• Other study ID #: 8070
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2, 2021
• Est. primary completion date: May 2, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

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

Related Conditions & MeSH terms

• Septate Uterus
• Uterine Septum

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]