Research studies

How you can take part

Professor Catherine Williamson’s Maternal & Fetal Disease Group began to investigate intrahepatic cholestasis of pregnancy (ICP) in 1997 and hers is now one of the largest research groups, focusing on cholestasis in Europe. ICP Support has been collaborating with this group since it started.

As a result, many women and their families have donated blood samples and provided data for studies into the condition. Their generosity has enabled the research to develop rapidly, and many scientific papers have been published. The group is also indebted to all the clinicians and midwives around the country who have helped to collect these samples and provide data.

To sustain this momentum more data is needed, (we don’t need samples for anyone who isn’t at Queen Charlotte’s & Chelsea Hospital, King’s College Hospital or the Princess Royal University Hospital - the three recruiting hospitals), and this is where you could help (whether you are pregnant or not). There are several studies taking place that have all been approved by ethics committees and the hospitals who provide sponsorship for them to take place. You will need to be resident in the UK.

The study that is currently running is the Intrahepatic Cholestasis of Pregnancy Research Study at Queen Charlotte’s & Chelsea Hospital, London. Professor Williamson is the Chief Investigator for this study. The research ethics committee that approved the study is https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/london-west-london-gtac/ and the approval number is 08/H0707/21

We also collect data for a control group of women who have been pregnant but who have not had any complications in their pregnancy. This helps the researchers to make sure that any new discoveries, such as a new genetic change, are specific to women with ICP rather than all pregnant women. If you have friends (not relatives) who might also be interested in helping us they can also take part.

Your data will make a difference, helping researchers add to existing knowledge of the condition – knowledge that has only been obtained because of the generosity of previous ICP and non-ICP families. One way the data has helped is in a large meta-analysis of ICP published in 2019, which was able to establish the threshold for risk of stillbirth in ICP, which has led to a change in clinical practice for people with the condition. It means that some women can now wait until 40 weeks of pregnancy to have their baby while others might have to have their around 35 weeks of pregnancy, slightly earlier than used to be recommended, but improving safety for the unborn baby. Ovadia C et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. The Lancet 2019; 393(10174): 899–909.
https://doi.org/10.1016/S0140-6736(18)31877-4

You are able to choose whether you want your data to be shared. In the meta-analysis only data that had permission to be shared was used and participants couldn’t be identified.

If you are interested in participating in this study you can find out what participation involves by reading the Patient Information Sheet below:

If you have any questions or want more information, please contact Jenny Chambers, who is the senior clinical trials coordinator for Professor Williamson: jennifer.chambers@nhs.net. Contacting Jenny does not commit you to taking part, as at this stage you are simply expressing an interest.