Acetaminophen, aspirin, ibuprofen, and amoxicillin are among the most commonly used medicines in pregnancy, but the safety of these medications with respect to birth defects is not established. Given the wide use of these drugs, even a small increase in the risk of birth defects may have considerable clinical and public health implications. This study uses the Pregnancy Health Interview Study/Birth Defects Study (PHIS/BDS) data to evaluate the association between these drugs and 1) specific malformations previously suggested to be associated with each of them, and 2) specific malformations that occur most commonly in the general population. In addition, we are evaluating other commonly used medications by systematically screening each of them in relation to the risk of specific malformations.

This study will take advantage of data already collected by the PHIS/BDS, a large ongoing multicenter case-control surveillance program of birth defects in the North America . The BDS identifies infants with a wide range of malformations, as well as non-malformed infants, at referral and birth hospitals. Within 6 months of delivery, study nurses interview mothers about demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking and alcohol consumption; and dietary intake.

Investigators:

Allen A. Mitchell, M.D., Principal Investigator
Sonia Hernández-Díaz, M.D., Dr.P.H., Co-Investigator
Martha M. Werler, Sc.D., Co-Investigator

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:

National Institute of Child Health and Human Development
(this study is nested within the Pregnancy Health Interview Study/Birth Defects Study)

Study Period:

2005 - Current

Contact Information:

Dawn Jacobs, RN, Project Coordinator (617) 734-6006

Participant Information:

(866) 896-1097 (toll free-bilingual English/Spanish line)