PIANO

PIANO (Pregnancy Inflammatory bowel disease And Neonatal Outcomes) is a national study of women with IBD and their children. This study looks at the safety of IBD medications on the pregnancy and short- and long-term outcomes of the children.

PIANO image

Purpose

Determine the safety of IBD medications on pregnancy outcomes and impact on children exposed in utero.

What are we measuring:

  1. Whether the level of biologic drug transferred across the placenta to the infant by the time of birth predicts the risk of infection or other adverse outcomes
  2. Whether the achievement of developmental milestones is affected by medication exposure
  3. Whether the rates of birth defects, adverse pregnancy outcomes and complications of labor and delivery are affected by IBD medications
  4. Whether second trimester drug levels can be used to adjust drug and minimize transfer across the placenta to the baby
  5. What are the outcomes of children out to 18 years of age based on exposure to IBD Medications in the womb
  6. Do Covid vaccine generated antibodies cross to the baby from the mother as measured by levels in the cord blood at birth

Little is known about the effects of azathioprine/6MP or biologic therapy (Remicade, Humira, Cimzia, Tysabri, Stelara, Simponi, Entyvio) and small molecules (Xeljanz, Zeposia, Rinvoq) on pregnant women and their babies.  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 illness.

Please see below our current results and outcomes. If you are interested in enrolling please call 415-885-3734 or email [email protected] 

What the Study Entails

The PIANO study mainly gathers information through questionnaires.  We ask that you complete a questionnaire at each trimester of your pregnancy, at the end of your pregnancy, 4, 9, and 12 months post-delivery, and once a year up to the age of 18 years of age. 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 that are needed will be sent to you via FedEx so you will not have to worry about finding material or having to provide it on your own.

Optional Tests

  • Subjects taking part in this study have the option of checking response to vaccines (Haemophilus influenza, tetanus toxoid) when their child is 7 months or older.  This is part of the standard of care to ensure that your infant had an appropriate response to vaccines.  If you choose to take part in this part of the study, a blood sample will be taken from your child by placing a needle in his/her vein.  Approximately 2 mL or ½ of a teaspoon of blood will be obtained.  You can choose not to give your infant’s blood sample for this test and still take part in this study. 
  • Subjects taking part in this study have the option of checking their infant’s blood at month 12 to determine if development of T and B cells is affected by the drug which they are taking.  The development of T and B cells is very important for keeping your child healthy and preventing infections. If you choose to participate in this part of the study, a blood collection kit will be sent to you prior to the blood draw.  This blood draw can be done at a local commercial lab or pediatrician’s office.  The blood sample will be taken from your child by placing a needle in their vein.  Approximately 2 mL or ½ of a teaspoon of blood will be obtained.  You can choose not to give your infant’s blood sample for this test and still take part in this study.
    • Both of these tests try to measure whether exposure to IBD drugs during pregnancy had a more long term impact on your child’s immune system.  So far results have been reassuring, but the more data we have the better we can determine this.
  • Subjects taking part in this study have the option of submitting their infant’s meconium and stool sample at birth, months 3, 6, and 9, and annually between ages 1-15 for analysis.  A stool collection kit will be sent to you if you choose to take part in this optional study.  The kit will include instructions for obtaining your infant’s first bowel movement of the day as well as instructions for packaging and shipping.  All postage will be prepaid.

Donate

If you would like to donate to the PIANO study, please click the "MAKE A GIFT" button below.  Any amount of contribution will be greatly appreciated and will help further our understanding of pregnancy and IBD.

MAKE A GIFT

Download Files
PIANO Consent Form