When a pregnant women initiates contact with CTIS, and after she has been provided information on the agent in question, she is asked if she would be willing to enroll in the pregnancy outcome study. If she agrees to participate, the following happens:

• She is orally consented and advised of her research rights and protections under HIPAA by the CTIS counselor. She is also mailed a written consent form and HIPAA addendum to be signed and returned to CTIS.
• A semi-structured telephone intake interview takes place where questions about pregnancy history, demographic data, medical and genetic background, exposures during pregnancy, and complications of the current pregnancy are asked.
• She is asked to maintain a pregnancy diary on a form that is mailed to her upon enrollment so she can document additional exposures or complications that occur after the intake interview.
• A CTIS staff member contacts her by telephone on one three additional occasions before the completion of the pregnancy to update exposures and pregnancy events and to answer any additional questions.
• She is mailed and asked to complete a standard depression questionnaire, the CES-D Scale.
• After delivery, a semi-structured telephone outcome interview is performed which includes questions on length of gestation, type of delivery, birth complication, birth size, breastfeeding practices and type of hospital stay. (The outcome interview is conducted for each woman whether she spontaneously aborts, electively terminates the pregnancy, or delivers a live born or stillborn infant).
• She is mailed a set of forms authorizing release of medical records from the birth hospital, obstetrician, pediatrician, and any other specialty physician or diagnostic facility involved in the pregnancy or the infant’s health care following birth.
• All live-born infants are physically examined for evidence of any major or minor malformations. This examination involves a careful standardized external physical evaluation of the child including measurements of the baby’s weight, length, head circumference, length of the ears, distance between the eyes, size of the eye openings and length of the upper lip.
• Every 6 months, a CTIS staff member will send her a letter asking if there has been any change in contact information and/or if she has any concerns regarding her child’s development.
• We will continue to keep in touch with her until the child is old enough to participate in the developmental assessments offered at different stages.