CWoW - The CERM Trial
Research type
Research Study
Full title
Chronic Endometritis and Recurrent Miscarriage - The CERM trial
IRAS ID
251756
Contact name
Siobhan Quenby
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Eudract number
2019-000585-38
Duration of Study in the UK
3 years, 7 months, 31 days
Research summary
Recurrent miscarriage (RM) causes considerable distress and has a huge psychological impact on women and their partners. The vast-majority of couples receive supportive care only, as few treatments have been shown to prevent miscarriage.
The aim of this research trial is to find out if antibiotics can reduce miscarriage. In some women the lining of the womb (the endometrium) is inflamed (a condition called endometritis). Researchers have found a link between this and miscarriage. A healthy endometrium is important for how the ovum (egg and sperm) attaches to the womb. It is thought that endometritis disrupts this process leading to a miscarriage. Treating endometritis with antibiotics may reduce the inflammation and miscarriages. This has not been tested. In this research trial, we are going to test this by comparing a 14 day course of antibiotic (doxycycline) against a placebo (‘dummy treatment’ which will look exactly the same as the antibiotic but contain no active ingredients), to find out if taking antibiotics reduces miscarriages and leads to more births. The trial will be double blind (means that neither the women nor the trial researchers know who is taking the antibiotic or placebo) randomised controlled trial (means who receives the antibiotic or placebo is decided by chance – in this trial a computer will decide). The trial will take place in NHS hospitals and will involve over 3,000 women.Not everyone who experiences repeated miscarriage has endometritis, so we need to take a biopsy (a small sample of tissue) from the endometrium and examine it under a microscope to see who does. We estimate half the women we test will have endometritis and be able to take part in the randomised controlled trial.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0462
Date of REC Opinion
20 Aug 2019
REC opinion
Further Information Favourable Opinion