Trust leads clinical trial of pioneering product to tackle threatened miscarriage

Experts from University Hospitals Coventry and Warwickshire (UHCW) NHS Trust are to lead a clinical trial of a novel device aimed at addressing threatened miscarriage.

More than 150,000 women a year in the UK could be helped by Callavid® which is designed to deliver vital doses of progesterone.

If approved, the product could become the world’s first drug-device combination product to treat threatened miscarriage.

Callavid® has been developed by scientists and biomedical engineers from Calla Lily Clinical Care who have secured £1 million in Invention for Innovation (i4i) funding from the National Institute for Health and Care Research (NIHR) for its first clinical trial later this year.

The clinical feasibility study will be led by consultant Professor Siobhan Quenby MBE - one of the world’s leading authorities on miscarriage and preterm birth - and the team in the Trial Management Unit at UHCW NHS Trust.

Professor Quenby, who specialises in obstetrics and reproductive health at UHCW NHS Trust, said: “New methods to reduce additional psychological anxiety are badly needed in this field. Through this innovation, one which is being pioneered right here in the UK, I believe there is potential to transform women’s experience.”

Callavid® works by improving the delivery of progesterone medication. Administering doses of vaginal micronised progesterone is the NICE-recommended guideline for women who have suffered at least one miscarriage and subsequently face “threatened miscarriage”, the clinical term for when there is bleeding during early pregnancy. It’s estimated that over 150,000 women in the UK could be eligible for prescriptions of progesterone for threatened miscarriage each year.

Progesterone is currently self-administered by patients via vaginal pessaries. This delivery method results in leakage, which can cause significant anxiety and inconvenience for patients at an already distressing time.

To avoid leakage of the prescribed medication before it has been absorbed into the body, many women lie down for an extended period after inserting each pessary. According to health economists, the avoidable cost to the economy and the NHS from the use of leaky progesterone pessaries for miscarriage prevention and IVF across England and Wales is £236 million per year.

Dr Lara Zibners, Co-founder and Chair of Calla Lily Clinical Care, said: “The NIHR funding will enable us to test our technology via a full feasibility study this autumn, bringing us one step closer to making this product available to help women at one of the most distressing moments of their lives.”

If approved, Callavid® would become the first drug-device combination product in the UK to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of threatened miscarriage.