MedSciNet has launched the database for the PITCHES study, Phase III trial in IntrahepaTic Cholestasis of pregnancy (ICP) to evaluate Efficacy of urSodeoxycholic acid (UDCA) in improving perinatal outcomes with parallel biobank collection for mechanistic studies. It is sponsored by King's College London and led by Dr Lucy Chappell. The goal is to strengthen current clinical guidelines for diagnosis and management of obstetric cholestasis and to protect the unborn children from poor outcomes.
ICP is the most common liver disease during pregnancy (affects approximately 1 in 150 pregnancies) and is associated with increased rates of pre-term labour, stillbirth and neonatal unit admission. UDCA is the main drug treatment used for ICP and previous studies have indicated a protective effect of UDCA treatment on the outcome for the baby. These studies have however lacked the statistical power to properly demonstrate this.
This multi-centre randomised controlled trial is designed provide definitive evidence for or against the role of UDCA in ameliorating adverse perinatal outcomes. To overcome the previous limitations, 291 women per treatment group will be involved. Another study aim is to include at least one fifth of participants that have elevated bile acids, since this has been associated with an increased rate of poor outcomes in ICP pregnancies.
A parallel study will be performed to investigate potential mechanisms of ICP causing pre-term birth and of the preventive effect of UDCA on these complications. For this purpose, samples, including blood, urine and faeces from the pregnant mother and placenta and umbilical cord blood) will be collected and analysed.