Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
NCT Number: NCT06498128
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Insomnia
Interventions: DRUG: Daridorexant|DRUG: Non-orexin receptor antagonist medications for insomnia|OTHER: No insomnia medication
Sponsor: Idorsia Pharmaceuticals Ltd.
Collaborators: Iqvia Pty Ltd
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 785
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2033-03
Locations: IQVIA, Boston, Massachusetts, 02210, United States

Summary:
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

Primary Outcome Measures: Major congenital malformations classified according to MACDP, Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential major congenital malformations identified by the participant's or the infant's healthcare providers will be evaluated by a qualified, independent committee of at least 3 teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status., Start of pregnancy up to 1 year of infant age
Secondary Outcome Measures: Pregnancy complications - number of participants with pre-eclampsia, The presence of hypertension on 2 occasions at least 4 hours apart after 20 weeks gestation (in a woman with previously normal blood pressure) and proteinuria; or, in the absence of proteinuria, a new onset of hypertension accompanied by one of the following conditions: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual symptoms., 20 weeks gestation until delivery/birth/labor|Pregnancy complications - number of participants with pregnancy-induced hypertension, High blood pressure associated with pregnancy, as diagnosed by the treating healthcare provider, i.e., elevated (systolic between 120-129 mmHg and diastolic less than 80 mmHg); Stage 1 hypertension (systolic between 130-139 mmHg or diastolic between 80-89 mmHg); or Stage 2 hypertension (systolic at least 140 mmHg or diastolic at least 90 mmHg)., 20 weeks gestation until delivery/birth/labor|Pregnancy complications - number of participants with pre-term labor, Regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy., Start of pregnancy up to 37 weeks gestation|Pregnancy complications - number of participants with gestational diabetes, Characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy., Start of pregnancy until delivery/birth/labor|Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination, Any induced or voluntary fetal loss during pregnancy., Start of pregnancy until delivery/birth/labor|Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion, Loss of a fetus due to natural causes at less than 20 weeks of gestation., Start of pregnancy up to 20 weeks gestation|Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth, Death of a fetus at or after 20 weeks of gestation., 20 weeks gestation up to birth|Pregnancy outcomes - number of participants with pregnancy outcome of live birth, Birth of a surviving neonate., 37 weeks gestation up to 40 weeks gestation|Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth, Live birth prior to 37 weeks gestation: early preterm (\< 34 weeks), late preterm (34-36 weeks), and early term (37-38 weeks)., Less than 34 weeks gestation up to 37 weeks gestation|Infant outcomes - number of infants with outcome of minor congenital malformations classified according to MACDP, Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential minor congenital malformations will be evaluated by at least 3, qualified, independent teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status., Start of pregnancy up to 1 year of infant age|Infant outcomes - infants categorized according to size for gestational age, All live births will be classified using the World Health Organization definition of birth weight, i.e., small (below the 10th percentile), appropriate (between the 10th and 90th percentile), or large (above the 90th percentile) for gestational age., At birth of infant|Infant outcomes - number of infants with outcome of low birth weight, Birth weight of less than 2500 g; subclassified into very low birth weight (\< 1500 g) and moderately low birth weight (1500 g to 2499 g)., At birth of infant|Infant outcomes - number of infants with outcome of infant death, Death of a live-born infant within the first year of life; subclassified as neonatal deaths (≤ 28 days of life) and infant deaths (29 to 365 days of life)., Birth of infant up to 1 year of infant age|Infant outcomes - number of infants with outcome of hospitalization for serious illness, In-patient admissions for treatment of potentially life threatening illnesses among live-born infants within the first year of life., Birth of infant up to 1 year of infant age|Infant outcomes - postnatal growth and development - weight-for-length, World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-length percentiles (weight in kilograms, length in centimeters)., Birth of infant up to 1 year of infant age|Infant outcomes - postnatal growth and development - head circumference-for-age, World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific head circumference-for-age percentiles (head circumference in centimeters, age in months and years)., Birth of infant up to 1 year of infant age|Infant outcomes - postnatal growth and development - length-for-age, World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific length-for-age percentiles (length in centimeters, age in months and years)., Birth of infant up to 1 year of infant age|Infant outcomes - postnatal growth and development - weight-for-age, World Health Organization Growth Charts (suitable for use in the US and EEA from birth to 24 months) will be applied for this study, where infant growth measurements will be used to estimate gender-specific weight-for-age percentiles (weight in kilograms, age in months and years)., Birth of infant up to 1 year of infant age