A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy (NCT05503927) | Clinical Trial Compass
By InvitationNot Applicable
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
United States1,139 participantsStarted 2023-01-02
Plain-language summary
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.
Who can participate
Age range15 Years – 45 Years
SexFEMALE
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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 2027).
* Aged 15-45 and female on the date of the last menstrual period (LMP).
* Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of LMP through 42 days after the pregnancy end date.
* Among the pregnancies that meet the inclusion criteria, three main cohorts of interest and two sub cohorts will be identified (one Wegovy-exposed cohort and two comparison cohorts):
* Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from estimated conception date (LMP +14) - 35 days to 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 estimated conception date-1 day to end of pregnancy.
* Phentermine or bupropion/naltrexone exposure from estimated conception date- 5 days to end of pregnancy.
* Cohort with Overweight/Obesity-
* 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…
What they're measuring
1
Number of Infants with Major Congenital Malformation (MCM)