RecruitingNCT03936335

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)


Sponsor

Regeneron Pharmaceuticals

Enrollment

3,930 participants

Start Date

Sep 30, 2019

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called dupilumab for people with adverse pregnancy outcomes and atopic dermatitis. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 49 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdupilumab

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

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NCT03936335


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