Monitoring pregnancy outcomes for women exposed to Stelara and Tremfya

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project aims to track pregnancies in women who have been treated with Stelara or Tremfya, either during pregnancy or within three months prior to their last menstrual period. The study will evaluate the potential effects of these medications on pregnancy outcomes, including the health and development of the child up to one year after birth. It seeks to identify both visible and subtle defects that may arise from medication exposure during pregnancy, ensuring comprehensive monitoring of fetal outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (LMP) for any number of days, at any time, at any dose, and at any time until completion of pregnancy.
* Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)

Exclusion Criteria:

* Women who have not have an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.

Where it's running

• University of California, San Diego
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Christina Chambers, PhD, MPH — University of California, San Diego
• Study coordinator: Diana Johnson, MS
• Email: d4johnson@ucsd.edu
• Phone: 877-311-8972

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.