Trial Outcomes & Findings for Nplate® Pregnancy Exposure Registry (NCT NCT02090088)

The registry was initiated in May 2009. The first participant enrolled in June 2010 and the last participant enrolled in December 2013. Eligible participants were currently pregnant women residing in the United States who had any exposure to Nplate at any time during pregnancy.

The Nplate® Pregnancy Exposure Registry (NPER) was to continue the follow-up of enrollees until April 2016; however, the NPER was terminated on 24 January 2014 because of the low number of participants enrolled.

Nplate® Pregnancy Exposure Registry

An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (eg, a cleft lip), require surgery, or are life-limiting).

An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A minor structural defect is defined as a defect which occurs in less than 4% of the population but which has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes).

Only those infants who have received medical evaluation and who have three or more minor defects will be considered "affected" for purposes of the evaluation of a pattern of minor defects.

Number of each of spontaneous abortions, elective abortions, and stillbirths among mothers who received Nplate® therapy at any time during the pregnancy.

Number of children with preterm birth (\<37 weeks gestation) or low birth weight (\<2,500 grams) among children born to mothers who have received Nplate® therapy at any time during the pregnancy.

Number of children born with intrauterine growth restriction (weight, length or head circumference less than tenth percentile for sex and gestational age) among mothers who have received Nplate® therapy at any time during the pregnancy.

In the first year of life, the incidence of all serious adverse events, as well as of nevi (birthmarks) and angiomata (benign tumors with blood vessels or lymph vessels), among infants whose mothers received Nplate® therapy at any time during the pregnancy.