Reproductive Outcomes Following Uterine Septum Resection (UTER-SEPTUM)

November 2, 2023 updated by: University Hospital, Strasbourg, France

Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

May 2, 2021

Study Completion (Actual)

July 2, 2021

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8070 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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