This study aims to determine whether it is possible and practical to study the safety of vaccines given in pregnancy.

Within the ongoing Pregnancy Health Interview Study (PHIS) / Birth Defects Study (BDS), investigators will determine what methods might most effectively be used to collect data on vaccine exposure in pregnancy as part of this ongoing surveillance program of birth defects in the United States. The study interviews mothers within 6 months after delivery about demographic, reproductive, medical, occupational, behavioral factors, medications, and diet.

The investigators plan to study approximately 450 mothers of infants with birth defects and 450 mothers of non-malformed infants. Based on various approaches designed to collect information on vaccine exposure in pregnancy, the study hopes to provide reliable estimates of how often specific vaccines are used in pregnancy. If successful, this effort promises an efficient and important approach to studying the safety of vaccines that are given to pregnant women.

Investigators:

Allen A. Mitchell, M.D., Principal Investigator
Carol Louik, Sc.D., Co-Investigator
Martha M. Werler, Sc.D., Co-Investigator

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.
Kathleen Sheehan, R.N.
Nancy Rodriguez, Interpreter
Carolina Tejedor Meyers, Interpreter

Research Assistants:

Joan Shander
Katherine Supnet
Paula Wilder

Source of funding:

Sanofi Pasteur, Inc
(this study is nested within the Pregnancy Health Interview Study/Birth Defects Study)

Study Period:

2006 - Current

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)