Obstetric cholestasis research study
Full Title: Obstetric Cholestasis Research Study*
Short Title: OC Research Study
Ethics Ref: 08/H0707/21
Sponsor: Imperial College, London
This study is taking place at Queen Charlotte’s & Chelsea Hospital, London; St Thomas’ Hospital, London; West Middlesex Hospital; Chelsea & Westminster Hospital; King’s College London; Nottingham University Hospitals NHS Trust (City Maternity Unit).
*The study still refers to ICP as obstetric cholestasis (OC) as it was opened in 2008 when OC was the more common term for the condition. Professor Williamson and her group have always published research papers using the term intrahepatic cholestasis of pregnancy (ICP) but recognised that women would know the condition better as obstetric cholestasis, which is why they set the studies up using that term. The name of this study is likely to be changed to ICP at some stage.
Broadly speaking, the aim of the OC Research Study is to better understand the condition. There are a range of objectives that it would like to achieve. Here’s what the protocol says about those objectives.
Study purpose, objectives & outcome
The aims of this study are to test the following hypotheses:
- Obstetric cholestasis is a disease that results from an inherited genetic predisposition
- Obstetric cholestasis is associated with qualitative and quantitative changes in maternal and fetal bile acids
- The placenta plays a role in bile acid transport and metabolism, and this is attenuated in pregnancies affected by obstetric cholestasis
- The pathways in the liver governing maternal and fetal bile acid levels are influenced by sex hormone metabolites, and may be attenuated in pregnancies affected by obstetric cholestasis
- Abnormal maternal and fetal bile homeostasis also occur in related metabolic diseases of pregnancy, e.g. diabetes and hypercholesterolaemia
Objectives and primary outcome measures
- Genetic Studies: to identify genes that cause/confer susceptibility for medical disorders of pregnancy (i.e. obstetric cholestasis).
- Metabolic Studies: to establish the relationship between abnormalities of bile acid, lipid and glucose homeostasis in the mother and babies. For these studies some samples will need to be taken when the study participant is fasting.
- Placental Studies: to delineate the mechanisms by which bile acids are transported across the placenta and to establish any effects that they may have on placental function.
- Fetal/offspring Studies: to establish whether the children of affected women have abnormal bile acid, lipid or glucose metabolism, and to determine the effect of the fetus’s genetic profile on the maternal disease and pregnancy outcomes.
At the moment the group is only recruiting in the UK. They would like to hear from women who have ICP (or have had it) or women who have, or have had, uncomplicated pregnancies (to act as controls). A control research participant is someone who has not had the condition that is being investigated but who is needed to compare any findings made in those people who are affected by the disease. It ensures that what had been found in the group with the disease are unique and wouldn’t be found in everyone else.
The group is permitted to collect a range of samples that typically include: blood, urine, stool samples, placenta and cord blood (birth samples are always collected after the baby has been born and so cannot harm your baby). You have a choice in what you donate: for example some women might not want to donate cord blood. If you are not having your baby at any of the hospitals mentioned above, a kit can be sent to you in which to collect the samples. Jenny will give you more information about how this works if you contact her.
If you are over 18 and think you may be interested in taking part have a look at the information sheets and then contact Jenny Chambers (firstname.lastname@example.org). Contacting Jenny does not commit you to taking part; nor does it commit the hospitals to including you in the study.