Summary

Eligibility
for females (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Christina Chambers (ucsd)
Headshot of Christina Chambers
Christina Chambers

Description

Summary

Details

This Organization of Teratology Information Specialists (OTIS) Pregnancy Registry, is a United States (US) based registry designed to monitor pregnancy and infant outcomes among women in the US and Canada. This study is a prospective, observational cohort study of pregnancy and infant outcomes in pregnant people with exposure to tralokinumab for atopic dermatitis compared to people who have atopic dermatitis who have not used tralokinumab during pregnancy.

Researchers will compare pregnancy outcomes of those who were exposed to tralokinumab during pregnancy to pregnancy outcomes in people who did not use tralokinumab anytime in pregnancy, or 16 weeks prior to pregnancy, but who may or may not have used another medication to treat their atopic dermatitis during pregnancy. Information about infant health will be collected through one year of age.

Keywords

Atopic Dermatitis, Eczema, AD, Tralokinumab, Adbry, Adtralza, Pregnancy, Infant, Dermatitis

Eligibility

Location

  • University of California San Diego (UCSD) accepting new patients
    La Jolla California 92093 United States

Lead Scientist at University of California Health

  • Christina Chambers (ucsd)
    Dr. Chambers is a professor of pediatrics at University of California, San Diego and Vice Chair of Clinical Research for the Department of Pediatrics at UCSD and Rady Children's Hospital. She is a perinatal epidemiologist, whose research is focused on environmental exposures and pregnancy and child health outcomes, including birth defects.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05938478
Study Type
Observational [Patient Registry]
Participants
Expecting 900 study participants
Last Updated