OTIS Autoimmune Diseases in Pregnancy Project
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
Conditions:
🦠 Crohn's Disease 🦠 Rheumatoid Arthritis 🦠 Ankylosing Spondylitis 🦠 Psoriatic Arthritis 🦠 Psoriasis
🗓️ Study Start (Actual) March 2012
🗓️ Primary Completion (Estimated) September 2023
✅ Study Completion (Estimated) October 2026
👥 Enrollment (Estimated) 925
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Diego, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Currently pregnant
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 June 2012
  • First Submitted that Met QC Criteria 20 February 2013
  • First Posted 22 February 2013

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 May 2023
  • Last Update Posted 24 May 2023
  • Last Verified May 2023