An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
Regeneron Pharmaceuticals
3,930 participants
Sep 30, 2019
OBSERVATIONAL
Conditions
Summary
The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.
Eligibility
Inclusion Criteria2
- Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP
- Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy
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Interventions
No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03936335