Research FAQs

What is the Pregnancy Outcome Study?

For some medications, chemicals and other exposures, there are not enough studies in human pregnancy to be able to say whether or not the agent can cause problems. One of our goals at CTIS is to do research to gather new information regarding the possible effects of particular exposures. Finding out whether particular exposures can cause problems will help prevent birth defects and developmental effects in the future.

Through the Pregnancy Outcome Study, we follow women and their children who have been exposed to certain medications, chemicals and other agents.

What are my rights if I participate in the Pregnancy Outcome Study?

Participation is voluntary. Information about your participation will be kept confidential. A CTIS research assistant will explain in detail your research rights and protections.

What will happen if I participate in the Pregnancy Outcome Study?

You will be asked to participate in the following:

• An initial intake interview over the phone
• We will ask you to keep track of additional exposures or complications that occur after the intake interview
• One to three more phone interviews during your pregnancy to update exposures and pregnancy events and to answer any additional questions you may have
• A pregnancy outcome phone interview
• Release of copies of medical records related to your pregnancy
• Every 6 months, a CTIS research assistant will send you a letter asking if there has been any change in contact information and if you have any concerns regarding your child’s development
• For some participants, we will ask you if you will agree to a pediatric exam of your child, conducted by one of the study’s pediatricians
• For some participants, we will ask if you would be willing to complete a set of questionnaires about your child’s development when he/she is between one and three years of age
• For some participants, we will ask if you will agree to a comprehensive neurobehavioral developmental assessment of your child conducted by a trained psychometrist

Will I be given any medication to take as part of this study?

No. We are only collecting information on medicine and other agents you are already exposed to.

What kind of questions might you ask me in the Pregnancy Outcome Study?

• Questions about your medical and pregnancy history, demographic data, any exposures during pregnancy, and any complications in your current pregnancy
• At the outcome interview we will ask questions about your delivery and pregnancy including length of gestation, type of delivery, any complications during delivery, birth size, breastfeeding practices and type of hospital stay. We will want to talk to you regardless of what happens with your pregnancy, including spontaneous miscarriage, elective termination, and delivery of a live born or stillborn infant.

How do I find out more about other research studies I can participate in?

Click on OTIS Studies to find out more information.