Ongoing Funding

• Apremilast Pregnancy Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project

   

  • Sponsor: Celgene
  • Date: 9/25/2014 – 9/24/2019
  • PI: Chambers

  The main goal of the study is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the possible teratogenic effect of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health through one year of age.

• California Birth Defects Monitoring Program

   

  • Sponsor: California Department of Health
  • Date: 4/01/2016 – 3/31/2019
  • PI: Chambers

  This contract is to manage the ongoing surveillance program for birth defects in representative California counties as conducted by the Maternal, Child and Adolescent Health Division of the California Department of Health.

• California Teratogen Information Service & Clinical Research Program (MotherToBaby California)

   

  • Sponsor: State of California: Department of Education
  • Date: Annual
  • PI: Jones

  Two major goals of this program are to provide telephone information to pregnant women and healthcare providers throughout the State of California regarding the teratogenicity of various agents and investigate the pregnancy outcomes of women with prenatal exposure to various agents.

• Certolizumab Pegol Pregnancy Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project

   

  • Sponsor: UCB Pharma, Inc.
  • Date: 2/13/2012- 2/12/2017
  • PI: Chambers

  The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Certolizumab Pegol Pregnancy Exposure Registry is to follow pregnant women with or without rheumatoid conditions or Crohn’s disease who have or have not been treated with certolizumab pegol during pregnancy to evaluate the possible effect of these diseases and/or this medication on the pregnancy outcome including child development and growth up to five years of age.

• Collaboration to Establish the Prevalence of FASD in San Diego, California

   

  • Sponsor: National Institutes of Health (NIH)/National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Date: 9/20/2010- 8/31/2017
  • PI: Chambers

  The goal of this study is to establish an accurate, population-based prevalence estimate of Fetal Alcohol Spectrum Disorders in San Diego by systematically evaluating a representative sample of children in the San Diego School System, children in foster care, and children who have developmental disabilities.

• Development of a Model Resource and Support Network for FASD-Affected Families in Tribal and Urban Native American Communities

   

  • Sponsor: NARCH VII: Native American Research Centers for Health
  • Date: 9/01/2013 – 8/31/2018
  • PI: Chambers

  This study develops a culturally tailored design for a model NOFAS program “from within” native community setting.

• Dysmorphology Core

   

  • Sponsor: National Institutes of Health (NIH)/National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Date: 9/30/2003- 5/31/2017
  • PI: Jones

  The major goal of this project is to evaluate children prenatally exposed to alcohol and unexposed comparison subjects. In order to train additional physicians this study will develop a training DVD to teach physicians an approach to diagnose FASD. This study will also develop a tele-communication system whereby physicians in remote areas with little or no expertise in diagnosis of FASD can consult with a remotely located expert on a physical examination of a child being evaluated for FASD.

• Early Identification of Affected Children and Risk Factors for FASD in Ukraine

   

  • Sponsor: National Institutes of Health (NIH)/National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Date: 9/30/2003 – 5/31/2017
  • PI: Chambers

  The main goal of this project is the identification of effective methods for prevention and early intervention for Fetal Alcohol Spectrum Disorders (FASD). In this longitudinal study in Ukraine, earlier identification and prevention of FASD is being evaluated in four areas: a) the contribution of pre and postnatal nutritional factors to risk for FASD, b) development of a preschool neurobehavioral testing battery appropriate for early identification of affected children, c) the utility of a novel and objective biomarker of exposure to alcohol, and d) exploration of genetic and epigenetic factors that may modify risk for FASD in mother/child pairs.

• Fetal Alcohol Syndrome Prevention, Identification, and Treatment: Trainings and Education for Healthcare Providers by the Western Practice and Implementation Center

   

  • Sponsor: Centers for Disease Control and Prevention (CDC)
  • Date: 9/20/2014 – 9/29/2018
  • PI: Jones

  The Western Practice and Implementation Center will develop, disseminate and evaluate discipline-specific trainings on fetal alcohol spectrum disorders for pediatricians and women’s health and perinatal nurses.

• Influence of Nutrition on Growth and Neurodevelopment in Children with FASD in Ukraine

   

  • Sponsor: National Institutes of Health (NIH)/National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Date: 9/10/2012- 6/30/2017
  • PI: Chambers

  Based on data from an ongoing intervention trial in Ukraine conducted in a sample of high-alcohol consuming pregnant women, this study will follow the approximately 300 children born to those women and comparison women who have been retained in the cohort study to evaluate the contribution or effect modification of child nutritional status on neurodevelopment and growth.

• Maternal and Child Federal Consolidated Program

   

  • Sponsor: Health Resources and Services Administration (HRSA)
  • Date: 9/01/2014 – 8/31/2017
  • PI: Jones

  The goal of this initiative is to improve maternal and fetal health outcomes by providing education, individualized counseling, improved access to resources, and advancing the knowledge base related to safety of exposures to medications and environmental agents before, during, and after pregnancy.

• Postmarketing Surveillance of Afluria Safety in Pregnancy

   

  • Sponsor: American Academy of Asthma, Allergy, and Immunology (AAAAI); Vaccines and Medications in Pregnancy Surveillance System (VAMPSS)
  • Date: 8/01/2013- 7/31/2017
  • PI: Chambers

  The main goal of this project is to evaluate the maternal and fetal risks associated with the use of the afluria influenza vaccine during pregnancy.

• Prospective Follow-Up of Pregnancy Exposure to Adalimumab

   

  • Sponsor: AbbVie (Abbott) Laboratories
  • Date: 12/01/2003- 7/12/2017
  • PI: Jones

  This study investigates pregnancy outcomes of women with rheumatic diseases and Crohn’s Disease and prenatal exposure to adalimumab compared to unexposed disease-matched and non-diseased control groups.

• The Mepolizumab Pregnancy Exposure Study: A VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy

   

  • Sponsor: GlaxoSmithKline LLC.
  • Date: 9/14/2016 – 7/31/2022
  • PI: Chambers

  The main goal of this project is to evaluate the maternal and fetal risks associated with the use of Mepolizumab during pregnancy.

• The Teriflunomide Pregnancy Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project

   

  • Sponsor: Genzyme (Sanofi-Aventis)
  • Date: 10/25/2011- 12/31/2019
  • PI: Chambers

  The main goal of this project is to evaluate the fetal risk associated with the use of a new multiple sclerosis drug during pregnancy.

• Tofacitinib Pregnancy Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project

   

  • Sponsor: Pfizer
  • Date: 6/17/2013 – 6/16/2018
  • PI: Chambers

  The main goal of this study is to follow pregnant women with or without rheumatoid arthritis who have or have not been treated with tofacitinib during pregnancy to evaluate the possible effect of the disease and/or this medication on pregnancy outcome including child development and growth up to one year of age.

• Ustekinumab Pregnancy Exposure Registry: An OTIS Autoimmune Diseases Pregnancy Project

   

  • Sponsor: Janssen Biotech, Inc
  • Date: 6/01/2013 – 12/31/2020
  • PI: Chambers

  The specific aim of this study is to monitor planned and unplanned pregnancies exposed to ustekinumab, to evaluate whether there are any teratogenic effects of this medication in pregnancy outcomes, and to evaluate potential effects of prenatal ustekinumab exposure on infant health status through one year of age.

• Vedolizumab Pregnancy Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project

   

  • Sponsor: Takeda Development Center Americas, Inc.
  • Date: 11/05/2015 – 11/04/2020
  • PI: Chambers

  The purpose of the OTIS Entyvio Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies in UC or CD female patients exposed to vedolizumab and to evaluate any possible association between this medication and pregnancy outcome, including the health of the mother, fetus, and infant.

Recently Completed

• Prospective Follow-Up Study of Pregnancy Exposure to Leflunomide: An OTIS Autoimmune Diseases in Pregnancy Project

   

  • Sponsor: Apotex, Inc, Barr Laboratories, Inc., TEVA pharmaceuticals, USA, Kali Laboratories, Sandoz Pharmaceuticals
  • Date: 7/18/2005- 7/31/2016
  • PI: Chambers

  The major goal of this project is evaluate the fetal risk associated with the use of the generic product leflunomide, a medication used for the treatment of rheumatoid arthritis, during the first trimester of pregnancy.

• Pregnancy Outcomes and Asthma Medications in Pregnancy: A Demonstration Project

   

  • Sponsor: Agency for Healthcare Research and Quality (AHRQ)
  • Date: 2/25/2010 – 9/27/2015
  • PI: Chambers

  In collaboration with the American Academy of Asthma, Allergy, and Immunology (AAAAI), and in conjunction with a complementary project conducted by the Slone Epidemiology Center’s Birth Defects Study (BDS), this cohort study will generate and test hypotheses related to the comparative risk (or safety) for birth defects and other adverse outcomes of pregnancy associated with asthma medications.

• H1N1 and Influenza Vaccines and Antiviral Medications in Pregnancy

   

  • Sponsor: Vaccines and Medications in Pregnancy Surveillance System (VAMPSS)
  • Date: 2/2010 – 9/2015
  • PI: Chambers

  The goals of this study are to monitor and evaluate fetal and maternal risk with respect to H1N1 vaccine, seasonal influenza vaccine, and antiviral medications used to prevent or treat influenza.

• Autoimmune Diseases in Pregnancy Project: The Tocilizumab Pregnancy Registry

   

  • Sponsor: Hoffman La Roche Genentech
  • Date: 11/01/2010- 10/31/2016
  • PI: Chambers

  The main goal for this project is to evaluate the fetal risk associated with the use of Actemra when used to treat rheumatoid arthritis in pregnancy.