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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1273-4411 | Other Identifier | World Health Organization (WHO) |
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This is an observational, retrospective, cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Exposed to Wegovy | Pregnant participants exposed to Wegovy during the first trimester (T1) (that is, estimated conception date - 35 days through <14 weeks gestational age [WGA]) and their linked infants will be observed in this retrospective observational study. |
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| Participants Exposed to Anti-obesity Medication (AOM) | Pregnant participants exposed to other Anti-obesity Medication (AOM) (phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone) during the first trimester (start of exposure identification window based on five times the half-life of each AOM through <14 WGA) and their linked infants will be observed in this retrospective observational study. |
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| Overweight/Obese Participants | Pregnant participants with obesity or overweight and 1 or more comorbid condition without exposure to Wegovy or other AOM during pregnancy will be observed in this retrospective observational study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study, therefore no intervention is used. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants with Major Congenital Malformation (MCM) | Number of infants with MCM is defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. | Birth up to 1 year of age |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants Experiencing Small for Gestational Age (SGA) Birth | Number of infants experiencing small for gestational age is defined as weight at birth in less than (<) 10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants. | Birth up to 1 year of age |
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Inclusion Criteria:
Exclusion Criteria:
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This is a study of prenatal exposure to Wegovy in pregnant women.
Pregnant participants exposed to Wegovy, other AOM and pregnant participants with obesity and overweight were observed retrospectively.
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| Name | Affiliation | Role |
|---|---|---|
| (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBM Watson Health™ Truven Marketscan | Ann Arbor | Michigan | 48108 | United States | ||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Number of infants with Developmental Delay |
Infant development delay will be defined as infants with evidence of one or more of the following outcomes in the first year of life: delayed milestone in childhood, other lack of normal physiological development, special screening for developmental disabilities. |
| Birth up to 1 year of age |
| Number of Infants With Postnatal Growth Deficiency | Number of infants with adverse postnatal growth will be defined as infants with evidence of the following outcomes in the first year of life: abnormal weight gain (insufficient or excessive weight gain), short stature, failure to thrive. | Birth up to 1 year of age |
| Number of Pregnant Participants Experiencing Stillbirth | Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (>=20) WGA. | up to 37 weeks of gestational age |
| Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB) | Number of pregnant participants experiencing SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at <20 WGA. | up to 37 weeks of gestational age |
| Number of Pregnant Participants With Preterm Delivery | Preterm birth is defined as a live birth occurring at <37 WGA. | Up to 37 weeks of gestational age |
| Number of Pregnant Participants With Pre-eclampsia/eclampsia | Pre-eclampsia/eclampsia is defined as new onset of hypertension with proteinuria occurring at >=20WGA through the six weeks following pregnancy end. | Up to 37 weeks of gestational age |
| Princeton |
| New Jersey |
| 08540 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |