SEPTUM
Research type
Research Study
Full title
Septum cohort study
IRAS ID
255975
Contact name
TJ Clark
Contact email
Sponsor organisation
Birmingham women's & Childrens hospital
Duration of Study in the UK
years, 1 months, 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 investigated. So currently we are performing a possibly harmful procedure in women who are trying to become pregnant without high level of the its effectiveness.
The TRUST study, a randomized controlled trial, aims to assess whether removal of this septum improves reproductive outcome in these women. For this purpose, women with a septate uterus who are trying to become pregnant and a history of one or more miscarriages, subfertility or preterm birth, are being randomised into surgery or no surgery. The sample size of this study is 68 women and the follow up duration is one year.
Alongside this trial, we want to collect information from women of reproductive age with a septate uterus in retrospect in a cohort study – The SEPTUM study (the current proposed study of this IRAS application) in order to maximise data pertaining to the reproductive outcomes of women with uterine septa, a relatively rare condition. Women in this cohort may have chosen to have surgical treatment or not and whilst these choices / management decisions will be non-random, such that outcomes will be subject to selection bias, the pragmatic observational study will provide data into a rare but important condition and longer term data relating to reproductive outcomes. We aim to collect data from a sample of 200 women diagnosed with a uterine septum.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0385
Date of REC Opinion
22 Nov 2018
REC opinion
Unfavourable Opinion