The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.
Study Type
OBSERVATIONAL
Enrollment
10
Clinical Trial Site
Iowa City, Iowa, United States
RECRUITINGClinical Trial Site
Nantes, France
RECRUITINGClinical Trial Site
Münster, Germany
Prevalence of Major Congenital Malformations
Major congenital malformations will be classified according to the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classification systems.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Prevalence of Minor Congenital Malformations
Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Prevalence of Pregnancy Outcomes
Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes
Other adverse fetal/neonatal/infant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death.
Time frame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
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Clinical Trial Site
Pavia, Italy
RECRUITINGClinical Trial Site
Groningen, Netherlands
RECRUITINGClinical Trial Site
Lisbon, Portugal
RECRUITINGClinical Trial Site
Madrid, Spain
RECRUITING