The results of the pilot trial described below can be found .
A follow-up trial, called PITCHES, began in November 2015. The information on this page relates only to the original PITCH trial, not to the new PITCHES trial.
PITCH (Pregnancy Intervention Trial in Cholestasis) is a research project to test the efficacy of UDCA, a drug often used to treat OC. It is a pilot study with the intention of moving on to a full-scale trial. The research is being conducted at various centres around the UK.
Below is what I wrote about PITCH in 2009. I can now tell you that we were successful in recruiting the numbers we needed for this trial, which meant that Professor Thornton could submit an application for further funding to recruit more hospitals into the larger trial. Sadly, our application was turned down. We are all incredibly disappointed, as without these large numbers any results from our pilot study are too small to be significant which means that policies that can guide clinicians in how to manage and treat the condition cannot be implemented. As a consequence it was decided that the results would be evaluated now. This evaluation is still taking place and I'll write again when I have something to report. We have not given up on applying for further funding and should this be successful you will be the first to know!
I am delighted to report that funding has now been secured for a larger trial, called PITCHES, and recruitment should start in November 2015. I will report more as the trial gets under way.
Every week I receive emails from women who have been diagnosed with obstetric cholestasis (OC). Most want information about the condition because their doctors are unable to answer all their questions. In most cases this is not deliberate; it’s usually a reflection of the small number of cases that clinicians are likely to see in their careers, thus limiting their own experience of managing and treating OC. But it highlights the need for clear, robust guidance for health professionals to ensure that ‘best practice’ takes place.
Working in this area has shown me just how difficult this is to implement. You cannot state that something is best practice simply because you have heard that it seems to work. For example, I know from my own experience of OC and from speaking to many hundreds of women with the condition over the years that tiredness and stress seem to exacerbate the itching therefore rest might seem a logical way to combat this problem. But I cannot state this as a fact because I would need to conduct a trial to prove (or disprove) my theory in order for it to become what is referred to as ‘evidence based’.
This same rule applies to other areas of OC such as drug treatment and delivery options. On the whole in the UK, most women receive Ursodeoxycholic Acid (UDCA) to treat the condition and will be delivered at around 37–38 weeks. Yet the ‘evidence’ to show that this is best practice is not compelling so, on this website, I can’t tell you that UDCA is 100% safe and will protect your baby because it hasn’t been proven. This means that it is hard for institutions such as the RCOG (Royal College of Obstetricians and Gynaecologists) to produce a comprehensive guideline on OC because of the lack of such evidence.
The absence of sound information means that for many women their pregnancy develops into something of a rollercoaster ride of emotions such as anxiety, fear and, often, depression. I know how very, very anxious I felt during my last pregnancy with Tim and I didn’t want other women to suffer in the way I did: it’s why I became so involved with raising awareness and working in this arena. Yet I am painfully aware that practice has not changed sufficiently to alleviate women’s stress and anxiety, which is why I welcomed the opportunity to become involved in a trial called PITCH.
PITCH (Pregnancy Intervention Trial in Cholestasis) is a pilot trial that hopes to establish how feasible it will be for researchers to conduct the larger trial that will be necessary. A large trial is required to achieve the high number of participants needed to prove statistically what researchers find. But research in this area in other countries has thus far not been successful, so a small pilot trial seems sensible to ‘test’ whether it can be conducted here in the UK. The research is headed by Professor Jim Thornton and Dr Vinita Gurung (Research Fellow) from the University of Nottingham and several other centres around the country will also be involved: Nottingham University Hospitals – City Hospital and Queens Medical Centre, Imperial College London – Queen Charlotte’s and St Mary’s Hospitals, St Thomas’ Hospital, Sunderland Royal Hospital, Good Hope & Heartlands Hospitals, Kings Mill Hospital and Rotherham General Hospital.
PITCH will have two ‘arms’ and is what is known as a ‘double blind random controlled trial’ (RCT). The first arm will investigate the efficacy and safety of UDCA. To establish this some women will receive UDCA and others won’t. This means that neither the woman, nor the clinician, will know if UDCA is being prescribed or whether a ‘placebo’ is being taken – hence the term: ‘double blind’ (the placebo tablet is harmless to both mother and baby). The second arm is to see whether early delivery is the ‘right’ thing to do in order to protect the baby from the risk of stillbirth. In this arm women will either be delivered by 37 weeks or allowed to spontaneously go into labour. Again, women will be randomly allocated, so they won’t know until after they have agreed to take part whether they will have a planned or spontaneous delivery. Women may be eligible for both arms depending on how many weeks of pregnancy they are when they are diagnosed with OC.
You can imagine my initial reaction to this pilot trial. How on earth could I agree to a trial where some women would not be given UDCA (something I support, although I also support the use of other drugs such as rifampicin) and where they would be allowed to spontaneously go into labour? The potential for stillbirth loomed before me. I therefore thought long and hard about agreeing to be a co-investigator.
I agreed for several reasons. The first is my understanding and belief that unless researchers can provide the evidence to show that UDCA is safe and efficient, guidelines will continue to reflect the lack of evidence and some women may be denied access to the drug. The second is that I also know that delivering the baby early is based on a small study conducted several years ago, so the evidence once again is not substantial enough to allow a guideline to advocate early delivery. Also, delivery at 37–38 weeks of gestation is not without risk. There are some large studies that show that there are increased rates of respiratory distress with earlier delivery. This is more of a risk when delivery is by caesarean section. The third and final reason, was that I knew that clinicians involved in the pilot study would be able to intervene and deliver early if they had concerns about the pregnancy, for example if the woman’s bile acids did not improve but became further elevated.
I was one of the first women to take UDCA in 1992 because I trusted my clinicians, Professor Elwyn Elias, my liver consultant, and Judith Weaver, my new obstetrician, and I would have done anything that might help me, my baby and other women. But medical practice has changed radically since the early nineties. Trust is now not enough. Clinicians are ethically and professionally bound to prove that what they recommend has been researched, is safe and works. With OC they cannot fulfil these criteria at present and this is why we need this trial. I am not saying that I believe all women with OC have a duty to take part – this has to be the choice of the woman. But I do want women with OC to receive a UK standardised care plan that will help them to cope with the condition, protect their baby and, potentially, reduce the risk of stillbirth. I believe that PITCH may help to achieve this and from my perspective this can’t happen soon enough.
Please do email me if you have any comments or concerns about PITCH or about what I have written.
Jenny Chambers – February 2009