Study on How Nusinersen Spinraza Affects Pregnant People With Spinal Muscular Atrophy and Their Babies

What this Trial Is About

This research aims to better understand the effects of nusinersen Spinraza4, a drug prescribed for spinal muscular atrophy SMA, on pregnant individuals with SMA and their babies. As treatment options allow people with SMA to reach pregnancy age, this observational study collects health information without changing medical care. The study compares pregnancy and birth outcomes among those exposed to nusinersen before or during pregnancy and those without SMA who havent received nusinersen. Participants include pregnant people with SMA from three SMA registries across different countries. The study observes those exposed to nusinersen within 14 months before the last menstrual period before conception, 14.5 months before conception, or anytime during pregnancy. Data is collected through registries, following participants until 3 months after delivery and their babies up to 2 years after birth. Participants provide health information each trimester, with doctors also contacted during pregnancy and after birth. Baby health is tracked at various ages up to two years. The study measures pregnancy losses, live births, birth defects, infant growth, and maternal and infant deaths up to 10 years. The overall study lasts at least 10 years from the first participants enrollment.

A Study to Learn How Nusinersen (Spinraza) Affects Participants With Spinal Muscular Atrophy (SMA) Who Took it Before or During Pregnancy And About The Health of Their Babies