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

Investigating Pregnancy Outcomes in Women with Atopic Dermatitis, also known as eczema

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 the effects of atopic dermatitis (AD) on pregnancy outcomes. This observational study will compare the incidence of adverse pregnancy outcomes, such as miscarriage or stillbirth, and the prevalence of adverse infant outcomes, like major congenital malformations or being small for gestational age, in women with AD who are treated with an investigational medication during pregnancy versus those who are not. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

Participants in this study will be observed for their medical records to gather data related to their pregnancy and infant outcomes. The study will not involve any changes to their treatment, as it is observational in nature.

  • Who can participate: Women with a diagnosis of atopic dermatitis and continuous medical and pharmacy benefit coverage for at least 6 months prior to and including the estimated last menstrual period (LMP) are eligible. A diagnosis code for AD must be present from up to 1 year before the estimated LMP through the end of the pregnancy.
  • Study details: Participants will have their medical records reviewed to collect data on pregnancy and infant outcomes. No changes to their current treatment will be made as this is an observational study.
Updated on 30 Jul 2025. Study ID: NCT03936335

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