The Obstetric Research Team team at the Norfolk and Norwich University Hospital has been named the ‘star recruiting’ site throughout the UK for May on the PITCHES study.
PITCHES is a Phase III trial investigating Obstsetric Cholestasis (OC) in pregnancy. Obstetric cholestasis is a rare complication of pregnancy leading to a build-up of bile acids in the bloodstream which causes a persistent itch in the last third of pregnancy. The trial is to evaluate if Ursodeoxycholic Acid (UDCA) improves this condition for perinatal outcomes (in the period immediately before and after birth)
The Research Team commented: “Obstetric Cholestasis is the most common pregnancy-specific liver disorder but can be potentially very serious and the extreme itching can be very distressing for women. There currently isn’t robust research to support the use of UDCA in improving pregnancy outcomes. Our aim is to find the best way of treating women with OC. We’re thrilled with recruitment so far and we’re really enjoying working on PITCHES! Controlled trials of Investigational Medicinal Products are notoriously difficult to co-ordinate, but the expertise of our Clinical Trials Pharmacists has really helped towards the success of this trial”.
The trial is a blinded placebo-controlled randomised trial to evaluate UDCA vs. placebo in women with OC between 20+0 to 40+6 weeks’ gestation and is being conducted at 30 centres across the UK with recruitment running for approximately 39 months.
For further information please visit https://www.npeu.ox.ac.uk/pitches