Autoimmune/Inflammatory Diseases in Pregnancy Study


Organization of Teratology Information Specialists (OTIS)
Michigan, Massachusetts, Mississippi, Minnesota, Montana, Nevada, Nebraska, Kansas, Kentucky, Louisiana, Maryland, Maine, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Alaska, Alabama, Arizona, Hawaii, Idaho, Florida, Georgia, Indiana, Iowa, Illinois, California, Arkansas, Delaware, District of Columbia, Colorado, Connecticut, Washington, Virginia, Vermont, Utah, Texas, Tennessee, South Dakota, Wyoming, Wisconsin, West Virginia

Study Objective:

The purpose of the MotherToBaby Autoimmune/Inflammatory Diseases in Pregnancy Study is to learn about effects to pregnancy outcome from autoimmune diseases, such as Crohn's disease and Ulcerative Colitis, as well as learn about the safety of medications used to treat these diseases during pregnancy.

Disease Information:

Crohn’s Disease, Ulcerative Colitis

Study Details:

Drug Comparison:

The MotherToBaby Autoimmune/Inflammatory Diseases in Pregnancy Study is being conducted by the Organization of Teratology Information Specialists (OTIS) and coordinated by the University of California, San Diego. OTIS is a non-profit organization and is dedicated to providing accurate, evidence-based information to patients and health care professionals about exposures during pregnancy and lactation. 

Our studies are observational, which means women who enroll will not be asked to take any medications or vaccines or change any part of their routine. Women who qualify for a study, will not only have the opportunity to interact with our expert staff who can provide additional support during their pregnancy, but they will also play a key role by helping us learn more about the safety of medications during pregnancy for their own benefit and the benefit of other pregnant women and their babies in the future.  

Eligible participants will be enrolled in one of three groups: 1) pregnant women with Crohn's Disease (CD) or Ulcerative Colitis (UC) who have been exposed to Cimzia or Entyvio during pregnancy, 2) pregnant women with CD or UC who have not been exposed to Cimzia or Entyvio during pregnancy, and 3) pregnant women without an autoimmune disease and without exposure to Cimzia or Entyvio.

Possible Risks and Side Effects:

This is an observational study, so there are no medication-associated risks.  

A participant may feel uncomfortable or anxious discussing sensitive issues about her pregnancy. 

Explanation of Participation:

Taking part in a study is easy and participants will not be asked to change anything about their normal routine, including taking prescribed medications. Enrollment involves several phone interviews during pregnancy and after birth, as well as the release of medical records for the pregnancy and the participant's child's pediatrician.

Observation Period:
Observation period is throughout pregnancy, and may be up to 5 years.

Participant Criteria:

Adult (18+)

Female

Patient Criteria:

Women may qualify if they are currently pregnant and have been diagnosed with an autoimmune/inflammatory disease with or without using medications or treatments. 

For More Information: http://www.MotherToBaby.org

Visit MotherToBaby.org   |  Call 1-877-311-8972  |   Email MotherToBaby@ucsd.edu 

The MotherToBaby is a service of the Organization of Teratology Information Specialists, which is a non-profit organization and is dedicated to providing accurate evidence-based, clinical information to patients and health care professionals about exposures during pregnancy and while breastfeeding. For more information about medication use or other environmental exposures in pregnancy and to learn more about participation in the study please call 877-311-8972 or email MotherToBaby@ucsd.edu. You may also visit our website at MotherToBaby.org 

Center Name:

Organization of Teratology Information Specialists (OTIS)

Site Location:

Michigan, Massachusetts, Mississippi, Minnesota, Montana, Nevada, Nebraska, Kansas, Kentucky, Louisiana, Maryland, Maine, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Alaska, Alabama, Arizona, Hawaii, Idaho, Florida, Georgia, Indiana, Iowa, Illinois, California, Arkansas, Delaware, District of Columbia, Colorado, Connecticut, Washington, Virginia, Vermont, Utah, Texas, Tennessee, South Dakota, Wyoming, Wisconsin, West Virginia

Principal Investigator:

(877) 311.8972
raandpregnancy@ucsd.edu

Site Coordinator(s):

MotherToBaby@ucsd.edu