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NCT05139446: UTER-SEPTUM
Reproductive Outcomes Following Uterine Septum Resection
trial in Uterine Septum in 400 participants. Completed in 2 July 2021.
2 May 2021
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 1 January 2020 |
| Primary completion | 2 May 2021 |
| Estimated completion | 2 July 2021 |
| Sites | 1 location across France |
Conditions studied
- Uterine Septum — all drugs for Uterine Septum →
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.
Verify or expand the search:
- PubMed search for NCT05139446
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Uterine Septum
Currently open trials in the same condition.
- NCT06315582 — Surgical Approach to Uterine Septum · NA · recruiting
- NCT03880435 — HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outc · NA · active not recruiting
Other University Hospital, Strasbourg, France trials
Trials by the same sponsor.
- NCT07418554 — Sleep Disturbances in Children and Adolescents With Post-traumatic Stress Disorder (PTSD): a Randomized Double-blind Pla · Phase 3 · not yet recruiting
- NCT07108582 — Reducing Chronic Pain After Lung Surgery: A Trial of Limiting NSAIDs During Recovery · Phase 3 · not yet recruiting
- NCT07302646 — Optimizing Reduced-Flow, Low-Volume Contrast Protocols for Cerebral Angiography in Unruptured Aneurysms · NA · not yet recruiting
- NCT07273968 — Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction · NA · not yet recruiting
- NCT07214103 — Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients With Septic Coagulop · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05139446 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Strasbourg, France
- Last refreshed: 3 November 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing