An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
NCT03936335 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3930
Last updated 2025-08-03
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.
Conditions
- Adverse Pregnancy Outcomes
- Atopic Dermatitis
Interventions
- DRUG
-
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.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-30
- Primary Completion
- 2027-01-21
- Completion
- 2027-01-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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