This is an international, longitudinal, observational study investigating pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy and for whom the outcome of pregnancy is not known at the time of enrolment. The maximal study duration per woman is 21 months, and infants will be followed for 52 weeks after birth.
The primary outcome measure is the occurrence of major congenital malformations.
Secondary outcome measures comprise pregnancy complications (e.g., pre-eclampsia, pre-term labor), pregnancy outcomes (e.g., elective termination, spontaneous abortion, fetal death or stillbirth, preterm birth, full-term live birth), and infant outcomes (e.g., minor congenital malformations, small for gestational age at birth, infant mortality, infant hospitalizations for serious illness, and postnatal growth and development).
204 pregnant women exposed to QUVIVIQ, 387 pregnant women exposed to other non-orexin receptor antagonist (non-ORA) medications, and 194 pregnant women with no exposure to any insomnia medications are targeted for enrollment. The sample size was estimated to ensure sufficient power to compare the prevalence of major congenital malformations, in the infants of women exposed to QUVIVIQ vs the infants of women exposed to other non-ORA medications for insomnia, in the primary analysis using a non-inferiority testing approach.
An Adjudication Committee (individuals with expertise in obstetrics, embryology, teratology, pharmacology, epidemiology, pediatrics, clinical genetics, and insomnia) will make recommendations on data collection and assist in the review of data and classification of specific pregnancy outcomes.
Participants will be required to sign a consent form allowing collection of data from their healthcare providers. Institutional Review Board and Independent Ethics Committee approval of the registry protocol and consent form will ensure the collection of data are scientifically and ethically sound.