Nplate® Pregnancy Exposure Registry — NPER  

Low Birth Weight Clinical Trial

Official title: Nplate® Pregnancy Exposure Registry (NPER)

Status Terminated

Clinical Trial Summary

US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate® therapy at any time during the pregnancy.

Clinical Trial Description

The purpose of the NPER is to monitor pregnancies exposed to Nplate® and to detect and record serious adverse events in infants up to one year after birth. The lack of adequate human fetal safety data for Nplate® makes the NPER an important component of the pharmacovigilance program on the safety of this drug. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Birth Defect
• Birth Weight
• Congenital Abnormalities
• Low Birth Weight
• Spontaneous Abortions

• NCT number: NCT02090088
• Study type: Observational [Patient Registry]
• Source: Amgen
• Status: Terminated
• Phase: N/A
• Start date: May 2009
• Completion date: January 2014