PITCHES: Phase III trial of UDCA in ICP: V1
Research type
Research Study
Full title
Phase III trial in Intrahepatic Cholestasis of Pregnancy (ICP) to Evaluate ursodeoxycholic acid (UDCA) in improving perinatal outcomes
IRAS ID
138590
Contact name
Lucy Chappell
Contact email
Sponsor organisation
King's College London
Eudract number
2014-004478-41
Duration of Study in the UK
3 years, 11 months, 28 days
Research summary
The main drug used to treat ICP (intrahepatic cholestasis of pregnancy) is ursodeoxycholic acid (UDCA). Our pilot study showed that a woman with ICP is willing to take part in a trial comparing UDCA with placebo (an identical tablet not containing the drug). Our study suggested that UDCA may protect the unborn baby from poor outcomes, but was not large enough to be certain.
However, the current guideline from the Royal College of Obstetricians and Gynaecologists (RCOG) states, “Women should be informed of the lack of robust data concerning protection against stillbirth and safety to the fetus or neonate”. Lack of robust data means that the trials did not have enough women taking part. Our larger trial would address this problem allowing the RCOG to have clearer guidelines. This matters because doctors use this guideline to direct their treatment.
We plan to evaluate UDCA or placebo on the rate of adverse outcomes on the baby: death, preterm delivery and neonatal unit admission.
In a parallel study with separate ethics approval (ref. 08/H0707/21), we are collecting samples to understand why ICP causes preterm birth and how it can cause the baby to be sick or die. We know that ICP babies have higher rates of breathing problems and spend longer on neonatal units, but we do not know whether this is due to high bile acid levels or because ICP pregnancies are often delivered early because doctors worry about the risk of stillbirth (Williamson et al 2004). This part of the study will try and find out why these problems happen and will also aim to find out if UDCA may prevent these complications.
This research will give vital information to help doctors understand and try and prevent the poor outcomes for the baby in ICP pregnancies.REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0010
Date of REC Opinion
18 Feb 2015
REC opinion
Further Information Favourable Opinion