The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance. Study start date is either start of data collection or first patient enrolled whatever occurs earlier. The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this surveillance program.
Study Type
OBSERVATIONAL
Enrollment
20
Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program
Wilmington, North Carolina, United States
RECRUITINGPrevalence rate of major congenital malformations (MCM) at birth
An abnormality of body structure or function that is present at birth; is of prenatal origin (i.e. birth defect); has significant medical, social or cosmetic consequences for the affected individual; and typically requires medical intervention.
Time frame: At birth
Prevalence rate of minor congenital malformations at birth
Time frame: At birth
Prevalence rate of molar or ectopic pregnancy
Molar pregnancy is defined as an abnormal pregnancy that happens when a sperm fertilizes an egg that does not contain any genetic material. Ectopic pregnancy is defined as a pregnancy that occurs outside of the uterine cavity, usually in one of the fallopian tubes.
Time frame: Throughout pregnancy, an average of 9 months
Prevalence rate of fetal loss
A fetal loss that occurs for any reason at any time during pregnancy. This includes spontaneous abortion (SAB), stillbirth, elective or therapeutic abortion, fetal loss (type not specified).
Time frame: Throughout pregnancy, an average of 9 months
Prevalence rate of live birth
The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.
Time frame: At birth
Prevalence rate of preterm birth
Time frame: At birth
Prevalence rate of small for gestational age (SGA)
Birth weight \<10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.
Time frame: At birth
Prevalence rate of neonatal death
Time frame: Within the first 28 days of life
Prevalence rate of infant death
Time frame: Throughout the first year of life
Prevalence rate of postnatal growth deficiency
Weight, length or head circumference in \<10th percentile for sex and age using standard growth charts.
Time frame: Throughout the first year of life
Prevalence rate of infant developmental delay
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC)
Time frame: Throughout the first year of life
Prevalence rate of infant hospitalization due to serious illness
Infant hospital visit due to a serious (i.e. results in significant disability, incapacity, or death; is life-threatening; requires inpatient or prolonged hospitalization; or is considered medically important)
Time frame: Throughout the first year of life
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