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NCT05139446: UTER-SEPTUM

Reproductive Outcomes Following Uterine Septum Resection

Completed Last updated 3 November 2023
What this trial tests

trial in Uterine Septum in 400 participants. Completed in 2 July 2021.

Timeline
1 January 2020
Primary endpoint
2 May 2021
2 July 2021

Quick facts

Lead sponsorUniversity Hospital, Strasbourg, France
StatusCompleted
Study typeOBSERVATIONAL
Enrollment400
Start date1 January 2020
Primary completion2 May 2021
Estimated completion2 July 2021
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, female only, with Uterine Septum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Uterine Septum

Currently open trials in the same condition.

Other University Hospital, Strasbourg, France trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05139446.

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