The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable. The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry. The design of this pregnancy registry follows current FDA guidance for designing and implementing pregnancy exposure registries.
Study Type
OBSERVATIONAL
Enrollment
1,329
Exposure to at least one dose of pitolisant at any time during pregnancy
Exposure to at least one dose of a comparator product at any time during pregnancy
Evidera (PPD)
Morrisville, North Carolina, United States
RECRUITINGMajor congenital malformation
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: Enrollment through the infant's first year of life
Minor congenital malformation
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Time frame: Enrollment through the infant's first year of life
Pre-eclampsia
High blood pressure and signs of liver or kidney damage occurring at \>20 gestational weeks.
Time frame: Enrollment through pregnancy outcome
Eclampsia
Seizures or coma in a pregnant woman with pre-eclampsia.
Time frame: Enrollment through pregnancy outcome
Spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks.
Time frame: Enrollment through pregnancy outcome
Stillbirth
As defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
Time frame: Enrollment through pregnancy outcome
Elective termination
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A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities.
Time frame: Enrollment through pregnancy outcome
Preterm birth
A live birth occurring at \<37 gestational weeks.
Time frame: Enrollment through the infant's first year of life
Small for gestational age
Weight, length, or head circumference at birth in \<10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Time frame: Enrollment through the infant's first year of life
Postnatal growth deficiency
Weight, length, or head circumference in \<10th percentile for sex and chronological age using standard growth charts
Time frame: Enrollment through the infant's first year of life
Infant development deficiency
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC).
Time frame: Enrollment through the infant's first year of life