Terminated/Withdrawn
Sponsor ID
20080046
Nplate® Pregnancy Exposure RegistryNPER
Study Details
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.
Protocol Summary
Primary Outcome Measures
Major birth defects
Timeframe: 12 months
Secondary Outcome Measures
Minor birth defects
Timeframe: 12 months
Minor birth defects
Timeframe: 12 months
Spontaneous and elective abortions, stillbirths
Timeframe: 9 months
Low birth weight
Timeframe: 12 months
IUGR
Timeframe: 12 months
All adverse events
Timeframe: 21 months
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.