This is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal complications and adverse effects in the developing fetus, neonate, and infant. * Outcomes in exposed infants, including growth and development, will be assessed through at least the first year of life. * Data will be collected for approximately 10 years.
Study Design Time Perspective: Retrospective and Prospective
Study Type
OBSERVATIONAL
Enrollment
100
intravenous infusion
exposed via pregnancy and lactation
Investigational site worldwide
Bridgewater, New Jersey, United States
RECRUITINGMaternal complications
Prevalence of pregnancy/labor/delivery/postpartum maternal complications
Time frame: through study completion, an average of 10 years
Pregnancy outcome
Prevalence of live births, spontaneous abortions (\<20 weeks of gestation), elective terminations, ectopic pregnancies, early fetal deaths (20 to 27 weeks of gestation), late fetal deaths (≥28 weeks of gestation), stillbirths and maternal deaths
Time frame: through study completion, an average of 10 years
Infant outcome
Number of occurrences of major congenital anomalies, neonatal deaths, development delays (growth, motor, neurologic, behavioral) through first year of life. Major congenital anomalies defined using the US Centers for Disease Control and Prevention (CDC) and growth and development assessments using CDC's Developmental Milestones 2021.
Time frame: through study completion, an average of 10 years
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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