This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Study Type
OBSERVATIONAL
Enrollment
785
Dosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
Dosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
No insomnia medication was administered.
IQVIA US Office
Durham, North Carolina, United States
RECRUITINGJodha Tishon
Toronto, Ontario, Canada
NOT_YET_RECRUITINGHôpital Gui de Chauliac
Montpellier, France
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.
Time frame: Start of pregnancy up to 1 year of infant age
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.
Time frame: 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).
Time frame: 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.
Time frame: Start of pregnancy up to 37 weeks gestation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charité - Universitätsmedizin Berlin
Berlin, Germany
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy
NOT_YET_RECRUITINGHospital Txagorritxu
Vitoria-Gasteiz, Spain
NOT_YET_RECRUITINGUniversity College London Hospitals
London, United Kingdom
NOT_YET_RECRUITINGPregnancy complications - number of participants with gestational diabetes
Characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 weeks gestation up to birth
Pregnancy outcomes - number of participants with pregnancy outcome of live birth
Birth of a surviving neonate.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Birth of infant up to 1 year of infant age