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RECRUITING
NCT03936335

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

OBSERVATIONAL

Enrollment

3930

Start Date

2019-09-30

Completion Date

2027-01-21

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DRUG

dupilumab

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)

Regeneron Research Site

Boston, Massachusetts, United States