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Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT — PROTECT  

Atopic Dermatitis Clinical Trial

Official title:
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

Clinical Trial Summary

The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy. The main question the study aims to answer is whether pregnant people who have been exposed to tralokinumab during pregnancy experience any differences in pregnancy and infant outcomes compared to women with atopic dermatitis who have not been exposed to tralokinumab during pregnancy. Participants are not required to take tralokinumab during the study. Participants will be asked to: - Complete 1-3 phone interviews during pregnancy and 1-2 phone interviews after delivery - Release medical records for pregnancy and for their child - Complete an online survey about their baby's development at 4 months and 12 months of age - May be asked to have a study doctor examine their child All information is collected remotely, and no visits to the study site are required.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05938478
Study type Observational [Patient Registry]
Source University of California, San Diego
Contact Diana Johnson, MS
Phone 877-311-8972
Email mothertobaby@health.ucsd.edu
Status Recruiting
Phase
Start date December 8, 2022
Completion date September 30, 2035
View Details
See also
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