Pregnancy in Crohn's and Colitis: Observations, Levels and Outcomes (PICCOLO)

Lead Investigators: A/Prof Sally Bell, Dr Emily Wright, Dr Ralley Prentice, Dr Emma Flanagan. 

Lead Sites: Monash Health Melbourne and St Vincent’s Hospital Melbourne

Project overview and aims: 

Our investigators are currently running a multicentre study on pregnant women with IBD (PICCOLO-X Study) to understand how to better manage IBD during pregnancy. 

Inflammatory bowel disease (IBD) is a chronic disease that largely affects women in their childbearing years.  Active disease is a primary factor predisposing to adverse pregnancy outcomes and most women will need to be on some form of medication throughout their pregnancy. This study will help to understand how levels of common medications (vedolizumab, ustekinumab and thiopurines (azathioprine, mercaptopurine) change during pregnancy and the effects of these medications as well as IBD itself on outcomes for both mother and baby. 

Eligibility criteria: 

To be eligible, patients must be

• Aged 18 years or older
• Have a confirmed diagnosis of IBD
• Be refereed be a treating gastroenterologist
• Be pregnant or planning on becoming pregnant in the next 12 months 
• Be willing and able to consent to the inventions described

The study leads can offer preconception counselling and drug metabolite monitoring. 

To find out more or to refer patients please contact Dr Ralley Prentice MBX_Piccolo@monashhealth.org.
 

Publications to date:

Flanagan E, Gibson PR, Wright EK, Moore GT, Sparrow MP, Connell W, . . . …Bell SJ; PICCOLO Study Group. Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure. Aliment. Pharmacol. Ther. 2020;52(10):1551-62.

Flanagan E, Wright EK, Hardikar W, Sparrow MP, Connell WR, Kamm MA, …Bell SJ; PICCOLO Study Group. Maternal thiopurine metabolism during pregnancy in inflammatory bowel disease and clearance of thiopurine metabolites and outcomes in exposed neonates. Aliment Pharmacol Ther. 2021;53(7):810-820.  

Flanagan E, Wright EK, Sparrow MP, Moore GT, Connell WR, De Cruz P, . . . Bell SJ; PICCOLO Study Group. A Single Educational Intervention Improves Pregnancy-Related Knowledge and Emotional Health Among Women With IBD Who Are Pregnant or Wish to Conceive. Inflamm Bowel Dis. 2021.