New Pre-Surgical Scoring System for Uterine Septum
Uterine Septum: Novel Pre-surgical Scoring System to Aid and Standardise Hysteroscopic Metroplasty
1 other identifier
interventional
100
1 country
1
Brief Summary
Comparing surgical outcomes of Hysteroscopic metroplasty for uterine septum when using the standard ESGE or ASRM classifications vs the novel scoring system dubbed Shawki Septum Scoring System. Outcomes based primarily on completion of the septal correction (no residual parts) and avoiding complications, the most significant of which are uterine perforation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2018
CompletedFirst Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedApril 21, 2023
April 1, 2023
5 years
March 27, 2023
April 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of patients with Complete Septum Correction
No residual septum on 3D ultrasound
1 month
Percentage of patients who had an intra-operative Uterine perforation
Diminishing the risk of intra-operative perforation of the fundus
during the surgery
Study Arms (2)
Hysteroscopic Metroplasty using ESHRE ASRM Classification
ACTIVE COMPARATORHysteroscopic Metroplasty using Shawki Septum Scoring System
ACTIVE COMPARATORInterventions
Utilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum
Utilising the current classification before performing hysteroscopic metroplasty
Eligibility Criteria
You may qualify if:
- Uterine Septum diagnosed by 3D ultrasound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shifa Hospital
Cairo, 11835, Egypt
Related Publications (6)
Rikken JFW, Kowalik CR, Emanuel MH, Bongers MY, Spinder T, de Kruif JH, Bloemenkamp KWM, Jansen FW, Veersema S, Mulders AGMGJ, Thurkow AL, Hald K, Mohazzab A, Khalaf Y, Clark TJ, Farrugia M, van Vliet HA, Stephenson MS, van der Veen F, van Wely M, Mol BWJ, Goddijn M. The randomised uterine septum transsection trial (TRUST): design and protocol. BMC Womens Health. 2018 Oct 5;18(1):163. doi: 10.1186/s12905-018-0637-6.
PMID: 30290803RESULTPractice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.
PMID: 27235766RESULTAlcazar JL, Carriles I, Cajas MB, Costa S, Fabra S, Cabrero M, Castro E, Tomaizeh A, Laza MV, Monroy A, Martinez I, Aguilar MI, Hernani E, Castellet C, Oliva A, Pascual MA, Guerriero S. Diagnostic Performance of Two-Dimensional Ultrasound, Two-Dimensional Sonohysterography and Three-Dimensional Ultrasound in the Diagnosis of Septate Uterus-A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Feb 20;13(4):807. doi: 10.3390/diagnostics13040807.
PMID: 36832295RESULTRikken JFW, Kowalik CR, Emanuel MH, Bongers MY, Spinder T, Jansen FW, Mulders AGMGJ, Padmehr R, Clark TJ, van Vliet HA, Stephenson MD, van der Veen F, Mol BWJ, van Wely M, Goddijn M. Septum resection versus expectant management in women with a septate uterus: an international multicentre open-label randomized controlled trial. Hum Reprod. 2021 Apr 20;36(5):1260-1267. doi: 10.1093/humrep/deab037.
PMID: 33793794RESULTNouri K, Ott J, Huber JC, Fischer EM, Stogbauer L, Tempfer CB. Reproductive outcome after hysteroscopic septoplasty in patients with septate uterus--a retrospective cohort study and systematic review of the literature. Reprod Biol Endocrinol. 2010 May 21;8:52. doi: 10.1186/1477-7827-8-52.
PMID: 20492650RESULTAgostini A, Bretelle F, Cravello L, Ronda I, Roger V, Blanc B. [Complications of operative hysteroscopy]. Presse Med. 2003 May 24;32(18):826-9. French.
PMID: 12870384RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yehia Shawki, MRCOG
Endo-Planet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Endoscopy Unit
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 21, 2023
Study Start
November 18, 2018
Primary Completion
November 30, 2023
Study Completion
December 30, 2023
Last Updated
April 21, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1 year following completion