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PIANO

PIANO: PREGNANCY IN INFLAMMATORY BOWEL DISEASE AND NEONATAL OUTCOMES

PI

Uma Mahadevan

Hypothesis

Women with IBD exposed to azathioprine/6-mp and anti-TNF therapies during pregnancy and conception have different pregnancy outcomes than women with IBD not exposed to these medications.  

Primary Objective

  • Determine whether the rates of congenital malformations, spontaneous abortion, preterm birth and small for gestational age (SGA) infants in a prospective national sample of women from the United States with IBD exposed to azathioprine/6MP or anti-TNF therapy are greater than those among IBD-affected women not exposed to these medications
  • Determine 4 year outcomes of infants born to mothers with IBD with respect to developmental delay, infections and other health related complications

 

Secondary Objectives

  • Determine the rate of neonatal complications up to one year from birth in a prospective national sample of children born to women from the United States with IBD
  • Determine whether the rate of any adverse pregnancy outcomes in a prospective national sample of women from the United States with IBD differ with respect to exposure to azathioprine/6MP or anti-TNF therapy
  • Determine factors that predict adverse pregnancy outcomes in a prospective national sample of women from the United States with IBD
  • Determine rates of disease activity during pregnancy and the post-partum in a prospective national sample of women from the United States with IBD
  • Determine whether adverse outcomes are more common when the expectant mother has active IBD than when the expectant mother has quiescent IBD

Determine the rate of neonatal complications (defined below) up to one year from birth in a prospective national sample of children born to women from the United States with IBD

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Interim Reports 2014