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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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