This multicenter case-control study was conducted in the areas surrounding Nashville, Philadelphia and San Diego; the states of Massachusetts and Rhode Island, Southern New Hampshire; and portions of New York State. Infants with problems and a sample of healthy infants without birth problems were identified through special arrangements with either state birth defect registries or through regular contact with approximately 28 participating institutions. Mothers of these infants were invited to take part in a telephone interview conducted by trained nurse-interviewers. The interview included 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. In total, 51,448 women were interviewed, making this one of the largest studies of its kind.

Sources of Funding:

• National Institutes of Health (NICHD, NHLBI, NIOSH, NIEHS)
• MCH Research Grants Program
• Glaxo-Smith Kline, Sanofi Pasteur, Novartis Vaccine and Diagnostics, other manufacturers
• FDA Cooperative Agreement
• Biomedical Advanced Research and Development Authority (BARDA)
• Agency for Healthcare Research and Quality (AHRQ)

Study Period:

1976 to 2015

Completed Data File:

51,448 subjects

Associated Studies:

• Genetic and Non-genetic Risk for Hirschsprung’s Disease
• Phthalates in Medications and Risk of Male Genital Defects
• Risk Factors for Folic Acid-resistant Spina Bifida
• Teratogenicity of Drugs Most Commonly Used in Pregnancy
• Vaccines And Medications in Pregnancy Surveillance System (VAMPSS)

– H1N1 and Seasonal Influenza Vaccines and Antiviral Medications in Pregnancy
– Asthma Medications in Pregnancy — A Demonstration Project
– Menveo Meningococcal Vaccine in Pregnancy