Reproductive Outcomes Following Uterine Septum Resection

Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05139446

Acronym

UTER-SEPTUM

Enrollment

400

Registered

2021-12-01

Start date

2020-01-01

Completion date

2021-07-02

Last updated

2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Septum

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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]

Countries

France

Outcome results