Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

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.

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.

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).

Regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy.

Characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy.

Any induced or voluntary fetal loss during pregnancy.

Loss of a fetus due to natural causes at less than 20 weeks of gestation.

Death of a fetus at or after 20 weeks of gestation.

Birth of a surviving neonate.

Live birth prior to 37 weeks gestation: early preterm (< 34 weeks), late preterm (34-36 weeks), and early term (37-38 weeks).

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.

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.

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).

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).

In-patient admissions for treatment of potentially life threatening illnesses among live-born infants within the first year of life.

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).

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).

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).

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).