TRUST
Research type
Research Study
Full title
The Randomised Uterine Septum Transection Trial
IRAS ID
203089
Contact name
TJ Clark
Contact email
Sponsor organisation
Birmingham Women's and Children's NHS Foundation Trust
Clinicaltrials.gov Identifier
NTR1676, Nederlands trial register
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Women with a septate uterus (division of the womb into two cavities) have an increased risk for miscarriages, subfertility and preterm birth. Removal of this septum seems to improve reproductive outcome in these women, but this has never been thoroughly been investigated. So currently we are performing a possibly harmful procedure in women who are trying to become pregnant without high level evidence of its effectiveness. The aim of this study is to assess whether removal of this septum improves reproductive outcome in these women. For this purpose, women with a sepate uterus who are trying to become pregnant and a history of one or more miscarriages, subfertility or preterm birth, will be randomized into surgery or no surgery. The follow-up of the study will be one year, or until the duration of the first pregnancy after randomization. The study is initiated in the Netherlands, and will be conducted in the UK at Birmingham Women’s Hospital. The sample size Is 68 women and the expectation is that the study will last one year.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0325
Date of REC Opinion
25 Apr 2019
REC opinion
Further Information Favourable Opinion