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

Study on Pregnancy Outcomes in Women with Skin Condition

Recruiting
18 years - 49 years
Female
Phase N/A
3930 participants needed
1 Location

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Adverse Pregnancy Outcomes, Atopic Dermatitis
  • Age: 18 years - 49 years
  • Gender: Female

Key Inclusion Criteria:

  • 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

This study investigates atopic dermatitis in women. It looks at the effects of the condition on pregnancy and infant outcomes.

The study evaluates the occurrence of pregnancy and infant outcomes in women with atopic dermatitis, focusing on those treated with an investigational medication during pregnancy compared to those who are not.

  • Who can participate: Women with atopic dermatitis and continuous medical and pharmacy benefit coverage for at least 6 months before and during pregnancy are eligible. A diagnosis code for atopic dermatitis is required from up to 1 year before pregnancy through the end of pregnancy.
  • Study details: Participants will be observed to assess outcomes during and after pregnancy, comparing those treated with an investigational medication to those who are not.
Updated on 30 Jul 2025. Study ID: NCT03936335

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