Frequently Asked Questions
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Is my information private?
- Yes! Your personal information will not be viewed by anyone outside the study team.
- Your data is deidentified. When data is analyzed by the biostatistician, they only see a number – not a name, phone or address.
What if my pregnancy does not go to term?
- These are very difficult times for the mother and her family and it is not infrequent among mothers with IBD
- This is also very critical information to know so we can see if there is any drug effect leading to pregnancy loss.
- We are very grateful to the mothers who fill out the end of pregnancy questionnaire when there is a pregnancy loss so we can document it for the study and can collect this information to see if there is a drug effect (so far, thankfully, we have not seen it). This is of course voluntary and we respect your wishes here and at any other time during the study.
If I choose to enroll in PIANO, am I committing to 18 years of questionnaires?
- No. You may withdraw from PIANO at any time. Of course, we would greatly appreciate continuing to collect this valuable information, but the most critical data is to the end of pregnancy and the first year of the child's life.
- Doing the annual questionnaires is optional, but greatly valued.
What will enrollment look like?
- We only enroll women who have IBD, are pregnant and live in the United States of America
- Women will fill out a questionnaire (do-it-yourself online portal, electronic forms or by telephone with a coordinator)
- These questionnaires are when you enter the study, every trimester, after birth, at months 4,9 and 12 after the baby is born and then once a year until they are 18 years old
- The Ages and States questionnaire, done in the first 4 years of life, is done in a different online system
Does my baby have to have blood draws to participate in PIANO?
- No. For mothers on biologics and small molecules and for the COVID vaccine study, we ask for blood to be drawn at birth from mother, the cord and the baby. The cord and the baby have very similar levels so drawing blood from the baby is optional.
- For the newer biologics we ask for infant samples at 3 and 6 months of age if drug is detectable at birth. This is also optional. It helps us know how long the biologic lasts in the baby's blood.
- We also ask for an optional baby sample at 1 year of age to check immune development.
How do I interpret the serum blood sample results?
- The samples represent the amount of blood in the mother at birth and the baby (cord samples represent baby levels of drug)
- For most of the biologics, the baby is born with higher drug levels than the mother. By 4-6 months of age this is usually completely gone from the baby's blood even if they are breastfeeding.
- Babies with detectable levels of drugs should not get live vaccines. In the US, we recommend no live vaccines in the first 6 months of life (just rotavirus). After that, live vaccines can be given. Inactive vaccines can be given from birth on schedule.
What if something happens but it is not time for my questionnaire?
- You can always reach out to your site coordinator or the main UCSF coordinator to provide us with this information so we can document it
What if I don't know the correct information for what happened?
- We can collect this information from your physician with your permission
Can I get medical advice from the PIANO team?
- Unfortunately not. However, on our publications page are many great resources that came out of PIANO for you to share with your local provider.