Randomized double-blind placebo controlled trial to assess the role of intrauterine cornual block (ICOB) in combination with direct cervical block in outpatient endometrial ablation

Birmingham Women's Hospital (UK)0 sites90 target enrollmentNovember 7, 2013

Overview

Registry

who.int

Start Date

November 7, 2013

End Date

July 31, 2014

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

Birmingham Women's Hospital (UK)

•Women between the ages of 18 \- 50 years presenting to the gynaecology outpatient clinic scheduled for an outpatient hysteroscopic intrauterine therapeutic intervention such as endometrial ablation

•1\. Women with contraindications to hysteroscopic procedures such as atypical endometrial hyperplasia or endometrial cancer, undiagnosed abnormal vaginal bleeding, current lower pelvic infection or uterine abnormalities
•2\. Women who are allergic to local anaesthesia
•3\. Not technically possible to perform a hysteroscopy e.g. women with distorted uterine cavity due to large fibroids
•4\. Women considered vulnerable (e.g. current mental illness, emotionally labile, or learning difficulties)
•5\. Women who decline to be randomised and request the additional anaesthetic or decline it will form a separate group to be studied and will be administered the VAS similar to the trial group. This group will be analysed separately to determine whether they are significantly different to those patients who consent to being part of the trial.