Research
“Everyone was very kind and made it very easy to participate.” – Anonymous

OTIS Autoimmune Diseases in Pregnancy Project

VOLUNTEER

You can help other pregnant women - please volunteer today!

Research into the effects of medications in pregnancy needs volunteers like you! If you are pregnant, you may be able to help. Please call or email to learn more about these research studies.

Are you pregnant?
Do you have an autoimmune disease?

Call: 877-311-8972
or contact us via email

(Please include your phone number and the best time to contact you.)

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You may be eligible for the OTIS Autoimmune Diseases in Pregnancy Project

If you are pregnant and have

Autoimmune diseases affect many women who are in their reproductive years. Many of the medications used to treat autoimmune diseases have not been well studied for use in pregnancy.

About the research study...

The OTIS Autoimmune Disease in Pregnancy Project is a North American effort to evaluate safety of medications used for the treatment of autoimmune diseases in pregnancy.
 
If you have an autoimmune disease and are pregnant you may qualify for this research study. Eligible participants receive ollow-up phone calls during pregnancy, and your child will receive a pediatric exam, performed by one of our participating physicians at no cost to you. Watch the video below and learn how beneficial a specialized exam can be for your child. To sign up for a study click here.
 

 

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Learn More About Medications Used to Treat AI Diseases and Pregnancy

Please download these files for more information:

Chambers CD, Johnson DL, Robinson LK, Braddock SR, Xu R, Lopez-Jimenez J, Mirrasoul N, Salas E, Luo YJ, Jin S, Jones KL. Birth outcomes in women who have taken leflunomide during pregnancy.  Abstract: Birth outcomes in pregnant women taking leflunomide. Arthritis Rheu. 2010 May;62(5):1494-503. [ PDF Download, 36KB]

Poster presentation: Pregnancy Outcomes in Women Exposed to Adalimumab: An Update on the Autoimmune Diseases in Pregnancy Project. Presented at the American College of Rheumatology in Chicago, IL November 2011. Johnson DL, Luo Y, Jones KL, Chambers CD.  Arthritis & Rheumatism. 2011 Oct; 63(10) S730-1874.  

Poster presentation: Pregnancy Outcome in Women Exposed to Etanercept: The OTIS Autoimmune Diseases in Pregnancy Project. Presented at the American College of Rheumatology (ACR) in San Francisco, CA October 2008. [PDF Download, 52KB]

This publication reviews the pregnancy safety information for RA Medications and discusses this and other research studies:

Chambers CD, Tutuncu ZN, Johnson D and Jones KL. 2006. Review: Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data. Arthritis Research & Therapy 8:225. [PDF Download, 82 KB]

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Current Study Participants: Download Forms Here

Change of Address Form (English) [DOC Download, 32 KB]

Change of Address Form (Spanish) [DOC Download, 32 KB]

Physician Info Form (English) [DOC Download, 68 KB]

Physician Info Form (Spanish) [DOC Download, 36 KB]

Diary (English) [DOC Download, 56 KB]

Diary (Spanish) [DOC Download, 56 KB]

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Healthcare Professionals:

Please use this form to refer your patients to our study:

Referral Form [web form]

Referral Form [Fax_referral_form_AI.doc, 366KB]

Referral Form [Fax_referral_form_AI.pdf, 210KB]

Brochure request form

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Research Study Sponsors:

Abbott Laboratories
Amgen
Apotex
Barr
Bristol-Myers Squibb
Genentech
Par Pharmaceutical
Roche
Sandoz
Sanofi-aventis
Teva

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All information collected will remain strictly confidential. Identity of the women and their children will not be used in any report or publication and all files are kept in a locked cabinet.

The coordinating center for the research study is located at the University of California, San Diego Medical Center in the Department of Pediatrics. The medical director is Dr. Kenneth Lyons Jones, a pediatrician and specialist in birth defects.

*OTIS is a national organization committed to research and the education of pregnant women and health care professionals about exposures during pregnancy.

 


Paroxetine (Paxil®)

While not every study agrees, Paxil use in the first trimester may cause a 1% increase in heart defects. See our FACTSHEET

Stress

It is unlikely that stress alone is able to cause physical birth defects. See our FACTSHEET.