with IBD and their children.
About the Study
We are doing the PIANO (Pregnancy Inflammatory bowel disease And Neonatal Outcomes) study to help us learn how IBD medications impact pregnancy outcomes and impact children exposed to IBD medications in utero.
Who can take part?
Women with IBD who become pregnant and receive care in the United States may be able to take part in this study.
What the study involves
- If you decide to take part, we will ask you to complete questionnaires throughout your pregnancy, after delivery, and yearly throughout your child's life. You may stop at any time.
- We also ask for blood work and a fecal calprotectin test at your 2nd trimester as well as blood work from you, your umbilical cord,and if you wish, your newborn at delivery.
- Depending on the results of your newborn's blood work at delivery we also ask for blood work (optional) from your newborn at 3 and 6 months post-delivery.
All materials you will need for this study will be sent to you via FedEx.
Why are we doing this study?
In this study, we want to answer the following questions:
- Are the rates of birth defects, adverse pregnancy outcomes and complications of labor and delivery affected by IBD medications?
- Will the level of biologic drug transferred across the placenta to the infant by the time of birth predict the risk of infection or other adverse outcomes?
- Is the achievement of developmental milestones affcted by medication exposure?
- What are the outcomes of children out to 18 years of age based on exposure to IBD Medications in the womb?
Through data collected from PIANO, we have a much better understanding of the safety of thiopurines (6mp, azathioprine) and anti-TNF biologics (infliximab, adalimumab, certolizumab, golimumab) during pregnancy and breastfeeding. Less is known about the newer biologics (ustekinumab, Risankizumab, vedolizumab) and small molecules (tofacitinib, upadacitinib, ozanimod) and PIANO seeks to enroll more patients on the newer medications, as well as the anti-TNFs to better assess short and long term safety in pregnancy. As many women receive these during their prime reproductive years, the information from PIANO will be valuable in guiding therapy of women with CD or UC who wish to have children while receiving this therapy for their IBD.