Obesity, Overweight, Pregnancy
Conditions
Brief summary
This is an observational 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.
Interventions
OTHERNo Intervention
This is a non-interventional study, therefore no intervention is used.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Inclusion criteria
* Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2034). * Date of conception between 04 June 2021 and 06 May 2033 (that is last menstrual period (LMP) 43 weeks prior to the latest pregnancy end date). * Aged 15-50 and female on the date of the LMP. * Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of conception through 42 days after the pregnancy end date. * Among the pregnancies that meet the inclusion criteria, four main cohorts and two sub cohorts of interest will be identified (two Wegovy-exposed cohorts and two comparison cohorts): * Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated date of conception to end of pregnancy. Two mutually exclusive cohorts will be identified based on first Wegovy exposure during pregnancy. 1. Wegovy injection-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy. 2. Wegovy tablet-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy. * Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone exposure, defined as the following: * Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from one day prior to estimated conception date to end of pregnancy. * Phentermine or bupropion/naltrexone exposure from five days prior to estimated conception date to end of pregnancy. * Cohort with Overweight/Obesity and at least one weight related comorbid condition- * Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg/m\^2) on a medical claim during the six month pre-pregnancy period. * Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg/m\^2 or less than 30 kg/m\^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period. * No exposure to Wegovy or other AOM during the defined exposure window in pregnancy. * Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at less than 14 WGA.
Exclusion criteria
* Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (that is, 35 days prior to estimated conception date through pregnancy end date). * Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date). * Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants with Major Congenital Malformation (MCM) | Birth up to 1 year of age | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants Experiencing Small for Gestational Age (SGA) Birth | Birth up to 1 year of age | 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. |
| Number of infants with Developmental Delay | Birth up to 1 year of age | 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. |
| Number of Infants With Postnatal Growth Deficiency | Birth up to 1 year of age | 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. |
| Number of Pregnant Participants Experiencing Stillbirth | up to 37 weeks of gestational age | Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (\>=20) WGA. |
| Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB) | up to 37 weeks of gestational age | 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. |
| Number of Pregnant Participants With Preterm Delivery | Up to 37 weeks of gestational age | Preterm birth is defined as a live birth occurring at \<37 WGA. |
| Number of Pregnant Participants With Pre-eclampsia/eclampsia | Up to 37 weeks of gestational age | Pre-eclampsia/eclampsia is defined as new onset of hypertension with proteinuria occurring at \>=20WGA through the six weeks following pregnancy end. |
Countries
United States
Contacts
STUDY_DIRECTOR(dept. 2834)
Novo Nordisk A/S
Outcome results
None listed