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NCT03936335Completed

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)

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
12343 (actual)
First submitted
30 Apr 2019
Start date
30 Sept 2019
Primary completion date
13 Apr 2026
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT03936335

What you commit to

  • Study type: Observational
  • Participants enrolled: 12343
  • From 30 Sept 2019 to the primary completion date, 13 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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
    • Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Age in the registry: 18 years to 49 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.