Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

MCMs include abnormalities in structural development that are medically or cosmetically significant are present at birth, and persist in postnatal life unless or until repaired as evaluated by independent advisors used throughout the registry.

Elective or therapeutic pregnancy termination is any induced or voluntary fetal loss during pregnancy. It will be subclassified as elective or therapeutic pregnancy terminations as whether it was due to a fatal anomaly or not.

Spontaneous abortion is defined as any loss of a fetus due to natural causes before 22 weeks of gestation.

Fetal death or stillbirth refers to the death of a fetus prior to complete expulsion or extraction from its mother at or after 22 weeks of gestation. Death is indicated by the fact that, after such separation, the fetus does not show any evidence of life (e.g., heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles). Fetal death occurring at or after 22 weeks but before 28 weeks of gestation is considered an early fetal loss. Fetal death occurring at or after 28 weeks is considered a late fetal loss.

A live birth refers to a complete expulsion or extraction from its mother of a surviving neonate breathing, or showing any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord has been cut or the placenta is attached. Any live birth before 37 weeks of gestation will be considered premature birth. Any live birth at or after 37 weeks but before 42 weeks of gestation will be considered full-term birth. Any live birth at or after 42 weeks of gestation will be considered post-term birth.

Maternal death is death of a pregnant woman during pregnancy, labor, or delivery. Registry will also report maternal deaths that occur up to 12 weeks postdelivery.

Neonatal death is death occurring in a neonate prior to 28 days of life.

Perinatal death is death occurring at or after 28 days of life and prior to 12 weeks of life.

Infant death is death occurring between 12 and 52 weeks of life, inclusive.

Infant growth measurements will be used to estimate gender-specific weight-for-length, head circumference-for-age, length-for-age, and weight-for-age percentiles. Developmental milestones (i.e., social/emotional, language/communication, neurocognitive, movement/physical development) will be used to determine results of infant status (i.e., below, above, or at age-appropriate achievement).

Pregnancy complications may include incidences of pre-eclampsia, eclampsia, pregnancy-induced hypertension, preterm labor, gestational diabetes and placenta previa.