Stelara Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis, Infectious Disease, Women's Studies |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | July 2020 |
| Contact: | Diana Johnson, MS |
| Email: | d4johnson@ucsd.edu |
| Phone: | 877-311-8972 |
Stelara® Pregnancy Exposure Registry 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 one year 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.
unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic
effect of these medications and to follow live born infants for one year 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.
The purpose of the Stelara Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy
Project is to follow pregnant women or women who have delivered a baby, who have been
treated with Stelara within 3 months of their last menstrual period (LMP) or during
pregnancy to evaluate the possible effect of this medication on the pregnancy outcome
including child development and growth up to one year of age.
Project is to follow pregnant women or women who have delivered a baby, who have been
treated with Stelara within 3 months of their last menstrual period (LMP) or during
pregnancy to evaluate the possible effect of this medication on the pregnancy outcome
including child development and growth up to one year of age.
Inclusion Criteria:
- Documentation of an exposure to Stelara (ustekinumab) 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)
Exclusion Criteria:
- Women who have not have an exposure to Stelara (ustekinumab) during pregnancy.
We found this trial at
1
site
9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Christina Chambers, PhD, MPH
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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