Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT (NCT05938478)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Diego (UCSD) — La Jolla, California
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of California San Diego (UCSD) — La Jolla, California
📞 Contact the Study Coordinator
Phone: (877) 311-8972
Email: mothertobaby@health.ucsd.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atopic Dermatitis
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- ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis — Phoenix, Arizona
- A Study of Barzolvolimab in Patients With Atopic Dermatitis — Birmingham, Alabama
- Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis — Chicago, Illinois
- A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis — Birmingham, Alabama
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Explore by condition: All Atopic Dermatitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.