The pregnancy in Crohn’s and colitis: Observations, levels and outcomes extension (PICCOLO-X) study
Researchers at Monash Health Melbourne and St Vincent’s Hospital Melbourne are looking for women with Inflammatory bowel disease who are pregnant, or who are planning pregnancy in the next 12 months, to participate in their study, PICCOLO-X.
The aim of this study is to develop a sophisticated, integrated method for monitoring and managing IBD activity in pregnancy to improve pregnancy outcomes. We are evaluating how levels of vedolizumab, ustekinumab and thiopurines (azathioprine, mercaptopurine) change in pregnancy, their degree of transfer to the baby, their clearance from the baby and if they have any effects of the immune system, liver function and other blood parameters of the baby. This study will help pregnant women with IBD and their doctors make informed decisions about their medical treatment in pregnancy, with a better understanding of the overall effects of IBD itself, and the medications taken for it, on pregnancy outcomes and the baby.
Involvement in this study will require review in our dedicated and highly specialised pregnancy and IBD clinics, conducted at Monash Medical Centre Clayton or St Vincent’s hospital Melbourne, either via telehealth or in person. These appointments will take place prior to you falling pregnant if possible, in each trimester, and after delivery. You will also be asked to undertake online or letter-based questionnaires regarding you baby’s health and development. You may undergo additional blood tests, including for drug levels, stool tests and intestinal ultrasounds, if you choose to as part of the study.
To be eligible the study, you must be:
- Aged 18 years and over
- Have a confirmed diagnosis of Inflammatory bowel disease, with a treating gastroenterologist who will be able to refer you to the study and collaborate in your care throughout pregnancy.
- Be pregnant or have an active desire to become pregnant in the next 12 months.
- Be willing and able to consent to the inventions described.
To learn more about the study, please contact Dr Ralley Prentice at [email protected]. You will need a referral from a gastroenterologist In order to be recruited to the study, so please contact and discuss with your usual treating team prior to making contact with our service.