This ongoing study of factors in pregnancy that may be related to the health of newborns focuses on the safety and risks of a wide range of environmental exposures (primarily medications) in pregnancy. The outcomes of primary interest include birth defects and complications of pregnancy such as prematurity and pregnancy-induced hypertension.
This multicenter case-control study is currently conducted in the metropolitan areas surrounding Boston, Philadelphia, and San Diego and in portions of New York State. Infants with birth defects and a sample of healthy infants without birth defects are identified through special arrangements with either state birth defect registries or through regular contact with approximately 35 participating institutions. Mothers of these infants are invited to take part in a telephone interview conducted by trained nurse-interviewers. The interview includes questions on medical history, previous pregnancies, nutrition, occupation, health behaviors, and smoking, as well as detailed questions on medication use and vaccines received in the period prior to conception through the entire pregnancy. To date, over 35,800 women have been interviewed, making this one of the largest studies of its kind.
In addition to the interview, participants are invited to provide cheek swab samples which are used to explore possible effects on pregnancy outcomes that might result from biologic differences. For example, genetic differences in the way medications are handled might affect risks of certain birth defects.
Associated Studies:
Investigators:
Allen A. Mitchell, M.D., Principal Investigator
Co-Investigators:
Martha M. Werler, Sc.D.
Carol Louik, Sc.D.
Study Staff:
Dawn Jacobs, R.N., M.P.H., Project Coordinator
Fiona Rice, M.P.H., Program Coordinator
Rita Krolak, R.N., Research Coordinator
Nastia Dynkin, Computer Programmer
Nurse Interviewers:
Clare Coughlin, R.N.
Moira Quinn, R.N.
Kathleen Sheehan, R.N.
Nancy Rodriguez, Interpreter
Carolina Tejedor Meyers, Interpreter
Research Assistants:
Joan Shander
Nicole Gonzalez
Sources of Funding:
National Institutes of Health ( NICHD, NHLBI, NIOSH, NIEHS)
MCH Research Grants Program
FDA Cooperative Agreement
Hoffman-LaRoche, other pharmaceutical manufacturers
Study Period:
1976 - Current
Current data file:
Approximately 32,700 subjects
Publications:
Link to Publications
Contact Information:
Dawn Jacobs, R.N., M.P.H., Project Coordinator (617) 734-6006
Participant Information:
(866) 896-1097 (toll free-bilingual English/Spanish line)
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