Pregnancy Health Interview Study (Birth Defects Study)

PHISThis was a study of factors in pregnancy that may be related to the health of newborns focusing on the safety and risks of a wide range of environmental exposures (primarily medications) in pregnancy. The outcomes of primary interest included birth defects and complications of pregnancy such as prematurity and pregnancy-induced hypertension.

This multicenter case-control study was conducted in the areas surrounding Philadelphia, Nashville, and San Diego; the states of Massachusetts and Rhode Island, Southern New Hampshire; and portions of New York State. Infants with birth defects and a sample of healthy infants without birth defects 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. Over 51,000 women were interviewed, making this one of the largest studies of its kind.

Investigators:

Allen A. Mitchell, M.D., Principal Investigator
Martha M. Werler, Sc.D., Co-Investigator
Carol Louik, Sc.D., Co-Investigator
Carla van Bennekom, M.P.H., Co-Investigator

Coordinators:

Coordinators
From left to right

Christina Coleman, PA-C, Research Coordinator
Fiona Rice, M.P.H., Program Coordinator
Dawn Jacobs, R.N., M.P.H., Project Coordinator

Nurse Interviewers:

Interviewers


Clockwise from top left

Kathleen Sheehan, R.N.
Susan Littlefield, R.N.
Moira Quinn, R.N.
Laurie Cincotta, R.N.
Clare Coughlin, R.N.

Interpreters:

Interpreters


From left to right

Laine Fletcher, Interpreter
Monica Martinez-Dale, Interpreter
Ileana Gatica, Interpreter

Research Assistants:

Julia Venanzi, Senior Research Assistant
Gabrielle Fortier
Michelle Eglovitch

Study Staff:

Nastia Dynkin, Computer Programmer

Offsite Staff:

Mark Abcede
Rady Children’s Hospital, San Diego, CA

Shannon Stratton
Vanderbilt Medical Center

Darryl Partridge, M.S. Special Education
New York State Department of Health

Joan Shander
Slone Epidemiology Center, Philadelphia, PA

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

Current Data File:

51,448 subjects enrolled

Boston Area

Boston Medical Center Boston, MA
Children’s Hospital Boston, MA
Kent County Memorial Hospital Warwick, RI
MCBDRP* Boston, MA
Women & Infants’ Hospital Providence, RI
Southern New Hampshire Medical
Center
Nashua, NH
Massachusetts Department of Public Health Birth Defect Registry Boston, MA

*Massachusetts Center for Birth Defects Research and Prevention – Massachusetts  Department of Public Health

Philadelphia Area

Abington Memorial Hospital Abington , PA
Albert Einstein Medical Center Philadelphia , PA
Alfred I. duPont Institute Wilmington, DE
Bryn Mawr Hospital Bryn Mawr , PA
Children’s Hospital of Philadelphia Philadelphia , PA
Christiana Care Health Services Wilmington , DE
Lankenau Hospital Wynnewood , PA
Lancaster General Hospital Lancaster , PA
Temple University Hospital Philadelphia , PA
Thomas Jefferson University Hospital Philadelphia , PA

Southern California

Children’s Hospital and Health Center San Diego, CA
Kaiser Zion Medical Center San Diego, CA
Palomar Medical Center Escondido, CA
Pomerado Hospital Poway, CA
Scripps Mercy Hospital San Diego, CA
Scripps Memorial Hospital , Encinitas Encinitas, CA
Scripps Memorial Hospital, La Jolla La Jolla, CA
Scripps Memorial Hospital , Chula Vista Chula Vista, CA
Sharp Mary Birch Hospital San Diego, CA
Sharp Grossmont Hospital La Mesa, CA
Sharp Chula Vista Hospital Chula Vista, CA
Tri-City Medical Center Oceanside, CA
UCSD Medical Center San Diego, CA

New York

New York State Department of Health Congenital Malformation Registry Troy, NY

Nashville

Vanderbilt University Medical Center Nashville, TN

2013 Spring 2010 Spring 2009 Fall 2006
English English English English
Spanish Spanish Spanish

  • Darling AM, Mitchell AA, Werler MM. Preconceptional iron intake and gestational diabetes mellitus. Int J Environ Res Public Health (in press). PMCID: PMC Journal – In Process.
  • Mitchell AA. Research challenges for drug-induced birth defects [commentary]. Clin Pharmacol Ther (in press).
  • Benedum CM, Yazdy MM, Parker SE, Mitchell AA, Werler MM. Association of clomiphene and assisted reproductive technologies on the risk for neural tube defects. Am J Epidemiol 2016. doi: 10.1093/aje/kwv322 (epub ahead of print).
  • Simeone RM, Feldkamp ML, Reefhuis J, Mitchell AA, Gilboa SM, Honein MA, Iskander J. CDC Grand Rounds: understanding the causes of major birth defects — steps to prevention. MMWR Morb Mortal Wkly Rep 2015;64(39):1104-7. doi: 10.15585/mmwr.mm6439a3.
  • Benedum CM, Yazdy MM, Mitchell AA, Werler MM. Impact of periconceptional use of nitrosatable drugs on the risk of neural tube defects. Am J Epidemiol 2015;182(8):675-84. doi: 10.1093/aje/kwv126.
  • Reefhuis J, Devine O, Friedman JM, Louik C, Honein MA, and the National Birth Defects Prevention Study. Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous reports. BMJ 2015;351:h3190. doi: 10.1136/bmj.h3190.
  • Mitchell AA, Louik C, Chambers C, Jones KL, Schatz M. Immunization surveillance systems for pregnant women [letter to the editor]. Pharmacoepidemiol Drug Saf 2015;24:669. doi: 10.1002/pds.3784.
  • Louik C, Kerr S, Kelley KE, Mitchell AA. Increasing use of ADHD medications in pregnancy [letter to the editor]. Pharmacoepidemiol Drug Saf 2015;24(2):218-20. doi: 10.1002/pds.3742. PMCID: PMC4313616.
  • van Gelder MM, Van Bennekom CM, Louik C, Werler MM, Roeleveld N, Mitchell AA. Maternal hypertensive disorders, antihypertensive medication use, and the risk of birth defects: a case-control study. Br J Obstet Gynaecol 2015;122:1002-9. doi: 10.1111/1471-0528.13138.
  • Ahrens KA, Louik C, Kerr S, Mitchell AA, Werler MM. Seasonal influenza vaccination during pregnancy and the risks of preterm delivery and small-for-gestational age birth. Paediatr Perinat Epidemiol 2014;28(6):498-509. doi: 10.1111/ppe.12152. PMCID: PMC4813306.
  • Yazdy MM, Mitchell AA, Werler MM. Maternal genitourinary infections and the risk of gastroschisis [editor’s choice]. Am J Epidemiol 2014;180(5):518-25. doi: 10.1093/aje/kwu157. PMCID: PMC4143079.
  • Louik C, Kerr S, Mitchell AA. First-trimester exposure to bupropion and risk of cardiac malformations. Pharmacoepidemiol Drug Saf 2014;23(10):1066-75. doi: 10.1002/pds.3661.
  • Parker SE, Yazdy MM, Mitchell AA, Demmer LA, Werler MM. A description of spina bifida cases and co-occurring malformations, 1976-2011. Am J Med Genet 2014;164(2):432-40. doi: 10.1002/ajmg.a.36324. PMCID: PMC4353584.
  • Chambers CD, Johnson D, Xu R, Luo Y, Louik C, Mitchell AA, Schatz M, Jones KL, and the OTIS Collaborative Research Group. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine 2013;31(44):5026-32. doi: 10.1016/j.vaccine.2013.08.097.
  • Louik C, Ahrens K, Kerr S, Pyo J, Chambers C, Jones KL, Schatz M, Mitchell AA. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: exposure prevalence, preterm delivery, and specific birth defects. Vaccine 2013;31(44):5033-40. doi: 10.1016/j.vaccine.2013.08.096.
  • Li Q, Mitchell AA, Werler MM, Yau WP, Hernández-Díaz S. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol Pract 2013;1(6):666-74.e1. doi: 10.1016/j.jaip.2013.07.008. PMCID: PMC4140658.
  • Yazdy MM, Mitchell AA, Tinker SC, Parker SE, Werler MM. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol 2013;122(4):838-44. doi: 10.1097/AOG.0b013e3182a6643c.
  • Lee D, Majumdar SR, Lipton HL, Soumerai SB, Vellozzi C, Chen RT, Glanz J, Marinac-Dabic D, Normand ST, Sedrakyan A, Mitchell AA, Dal Pan GJ, Blackburn S, Manzo C, Seidling HM, Bates DW, Robb MA, Sherman RE, Strom BL, Schinnar R, Hennessy S. Special applications of pharmacoepidemiology. In: Strom BL, Kimmel SE, Hennessy S, eds. Textbook of pharmacoepidemiology. 2nd ed. West Sussex, UK: Wiley-Blackwell, 2013:339-406.
  • Benedum CM, Yazdy MM, Mitchell AA, Werler MM. Risk of spina bifida and maternal cigarette, alcohol, and coffee use during the first month of pregnancy. Int J Environ Res Public Health 2013;10:3263-81. doi: 10.3390/ijerph10083263.
  • Thorpe PG, Gilboa SM, Hernández-Díaz S, Lind J, Cragan JD, Briggs G, Kweder S, Friedman JM, Mitchell AA, Honein MA, and the National Birth Defects Prevention Study. Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk. Pharmacoepidemiol Drug Saf 2013;22(9):1013-8. doi: 10.1002/pds.3495. PMCID: PMC3996804.
  • Yau WP, Mitchell AA, Lin KJ, Werler MM, Hernández-Díaz S. Use of decongestants during pregnancy and the risk of birth defects. Am J Epidemiol 2013;178(2):198-208. doi: 10.1093/aje/kws427. PMCID: PMC3816336.
  • Parker SE, Yazdy MM, Tinker SC, Mitchell AA, Werler MM. The impact of folic acid intake on the association among diabetes mellitus, obesity, and spina bifida. Am J Obstet Gynecol 2013;209(3):239.e1-8. doi: 10.1016/j.ajog.2013.05.047.
  • Margulis AV, Mitchell AA, Hernández-Díaz S. Reply to Journal Club Roundtable [letter to the editor]. Am J Obstet Gynecol 2013;209(1):72. doi: 10.1016/j.ajog.2013.02.017.
  • Hernández-Díaz S, Su YC, Mitchell AA, Kelley KE, Calafat AM, Hauser R. Medications as a potential source of exposure to phthalates among women of childbearing age. Reprod Toxicol 2013;37:1-5. doi: 10.1016/j.reprotox.2013.01.001. PMCID: PMC3729282.
  • Lin KJ, Mitchell AA, Yau WP, Louik C, Hernández-Díaz S. Safety of macrolides during pregnancy. Am J Obstet Gynecol 2013;208(3):221.e1-8. doi: 10.1016/j.ajog.2012.12.023. PMCID: PMC3581717.
  • Van Marter LJ, Hernández-Díaz S, Werler MM, Louik C, Mitchell AA. Nonsteroidal antiinflammatory drugs in late pregnancy and persistent pulmonary hypertension of the newborn. Pediatrics 2013;131:79-87. doi: 10.1542/peds.2012-0496. PMCID: PMC3529942.
  • Louik C, Chambers C, Jacobs D, Rice F, Johnson D, Mitchell AA. Influenza vaccine safety in pregnancy: can we identify exposures?. Pharmacoepidemiol Drug Saf 2013;22:33-9. doi: 10.1002/pds.3336.
  • Radin RG, Mitchell AA, Werler MM. Predictors of recall certainty of dates of analgesic medication use in pregnancy. Pharmacoepidemiol Drug Saf 2013;22:25-32. doi: 10.1002/pds.3300. PMCID: PMC3443548.
  • Kelley KE, Chaplin EL, Mitchell AA. “Phthalates”: Kelley et al. respond [letter to the editor]. Environ Health Perspect 2012;120(11):a416. doi: 10.1289/ehp.1205763R.
  • Ahrens K, Lash TL, Louik C, Mitchell AA, Werler MM. Correcting for exposure misclassification using survival analysis with a time-varying exposure. Ann Epidemiol 2012;22:799-806. doi: 10.1016/j.annepidem.2012.09.003. PMCID: PMC3489973.
  • Lin KJ, Mitchell AA, Yau WP, Louik C, Hernández-Díaz S. Maternal exposure to amoxicillin and the risk of oral clefts. Epidemiology 2012;23(5):699-705. doi: 10.1097/EDE.0b013e318258cb05. PMCID: PMC3729019.
  • Margulis AV, Mitchell AA, Gilboa SM, Werler MM, Mittleman MA, Glynn RJ, Hernández-Díaz S, and the National Birth Defects Prevention Study. Use of topiramate in pregnancy and risk of oral clefts. Am J Obstet Gynecol 2012;207(5):405.e1-7. doi: 10.1016/j.ajog.2012.07.008. PMCID: PMC3484193. 
  • Yazdy MM, Tinker SC, Mitchell AA, Demmer LA, Werler MM. Maternal tea consumption during early pregnancy and the risk of spina bifida. Birth Defects Res A Clin Mol Teratol 2012;94(10):756-61. doi: 10.1002/bdra.23025.
  • Mitchell AA. Studies of drug-induced birth defects. In: Strom BL, Kimmel SE, Hennessy S, eds. Pharmacoepidemiology. 5th ed. West Sussex, UK: Wiley-Blackwell, 2012:487-504.
  • Kelley KE, Hernández-Díaz S, Chaplin EL, Hauser R, Mitchell AA. Identification of phthalates in medications and dietary supplement formulations in the U.S. and Canada. Environ Health Perspect 2012;120(3):379-84. doi: 10.1289/ehp.1103998. PMCID: PMC3295354.
  • Collett BR, Cloonan YK, Speltz ML, Anderka M, Werler MM. Psychosocial functioning in children with and without orofacial clefts and their parents. Cleft Palate Craniofac J 2012;49(4):397-405. doi: 10.1597/10-007.
  • Mitchell AA. Fetal risk from ACE inhibitors in the first trimester–evidence is reassuring, but risks remain from the hypertension itself [editorial]. BMJ 2011;343:d6667. doi: 10.1136/bmj.d6667.
  • Yau WP, Lin KJ, Werler MM, Louik C, Mitchell AA, Hernández-Díaz S. Drug certainty-response in interview-based studies. Pharmacoepidemiol Drug Saf 2011;20:1210-6. doi: 10.1002/pds.2234. PMCID: PMC3222943.
  • Gilboa S, Broussard C, Devine O, Duwe K, Flak A, Boulet S, Moore C, Werler MM, Honein M. Influencing clinical practice regarding the use of antiepileptic medications during pregnancy: modeling the potential impact on the prevalences of spina bifida and cleft palate in the United States. Am J Med Genet C Semin Med Genet 2011;157:234-46. doi: 10.1002/ajmg.c.30306.
  • Werler MM, Louik C, Mitchell AA. Case-control studies for identifying novel teratogens. Am J Med Genet C Semin Med Genet 2011;157:201-8. doi: 10.1002/ajmg.c.30307. PMCID: PMC3483035.
  • Ahrens K, Yazdy M, Mitchell AA, Werler MM. Folic acid intake and spina bifida in the era of dietary folic acid fortification. Epidemiology 2011;22(5):731-7. doi: 10.1097/EDE.0b013e3182227887.
  • Mitchell AA. Adverse drug reactions in utero: perspectives on teratogens and strategies for the future [editorial]. Clin Pharmacol Ther 2011;89:781-3. doi: 10.1038/clpt.2011.52.
  • Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernández-Díaz S, and the National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011;205:51.e1-8. doi: 10.1016/j.ajog.2011.02.029. PMCID: PMC3793635.
  • Yazdy MM, Mitchell AA, Liu S, Werler MM. Maternal dietary glycaemic intake during pregnancy and the risk of birth defects. Paediatr Perinat Epidemiol 2011;25:340-6. doi:10.1111/j.1365-3016.2011.01198.x. PMCID: PMC3474333.
  • Werler MM. Birth defects. In: Buck-Louis GM, Platt RW, eds. Reproductive and perinatal epidemiology. New York: Oxford University Press, 2011:186-203.
  • Schatz M, Chambers CD, Jones KL, Louik C, Mitchell AA. The safety of influenza immunizations and treatment during pregnancy: the Vaccines and Medications in Pregnancy Surveillance System. Am J Obstet Gynecol 2011;204(6 Suppl. 1):S64-8. doi: 10.1016/j.ajog.2011.01.047.
  • Dufton L, Speltz ML, Kelly JP, Leroux B, Collett BR, Werler MM. Psychosocial outcomes in children with hemifacial microsomia. J Pediatr Psychol 2011;36(7):794-805. doi: 10.1093/jpepsy/jsq112. PMCID: PMC3146752.
  • Collett BR, Speltz ML, Cloonan YK, Leroux BG, Kelly JP, Werler MM. Neurodevelopmental outcomes in children with hemifacial microsomia. Arch Pediatr Adolesc Med 2011;165(2):134-40. PMCID: PMC3142696.
  • Toh S, Mitchell AA, Anderka M, de Jong-van den Berg LTW, Hernández-Díaz S, and the National Birth Defects Prevention Study. Antibiotics and oral contraceptive failure: a case-crossover study. Contraception 2010;83(5):418-25. doi: 10.1016/j.contraception.2010.08.020.
  • Hernandez RK, Mitchell AA, Werler MM. Decongestant use during pregnancy and its association with preterm delivery. Birth Defects Res A Clin Mol Teratol 2010;88:715-21.
  • Louik C, Schatz M, Hernández-Díaz S, Werler MM, Mitchell AA. Asthma in pregnancy and its pharmacologic treatment. Ann Allergy Asthma Immunol 2010;105:110-7. PMCID: PMC2953247.
  • Mitchell AA. Proton-pump inhibitors and birth defects–some reassurance, but more needed [editorial]. N Engl J Med 2010;363(22):2161-3.
  • Louik C, Gardiner P, Kelley K, Mitchell AA. Use of herbal treatments in pregnancy. Am J Obstet Gynecol 2010;202(5):439.e1-10. PMCID: PMC2867842.
  • Burris HH, Mitchell AA, Werler MM. Periconceptional multivitamin use and its association with infant birth weight disparities. Ann Epidemiol 2010;20:233-40. doi: 10.1016/j.annepidem.2009.12.003.
  • Werler MM. Hypothesis: could Epstein-Barr virus play a role in the development of gastroschisis? Birth Defects Res A Clin Mol Teratol 2010;88(2):71-5. doi: 10.1002/bdra.20640.
  • Yazdy MM, Liu S, Mitchell AA, Werler MM. Maternal dietary glycemic intake and the risk of neural tube defects. Am J Epidemiol 2010;171(4):407-14. doi: 10.1093/aje/kwp395. PMCID: PMC2842193.
  • Hobbs CA, Shaw GM, Werler MM, Mosley B. Folate status and birth defect risk: epidemiological perspective. In: Bailey LB, ed. Folate in health and disease. 2nd ed. Boca Raton, FL: CRC Press, 2009:133-54.
  • Toh S, Mitchell AA, Louik C, Werler MM Chambers CD, Hernández-Díaz S. Antidepressant use during pregnancy and the risk of preterm delivery and fetal growth restriction. J Clin Psychopharmacol 2009;29(6):555-60. doi: 10.1097/JCP.0b013e3181bf344c. PMCID: PMC3206605.
  • Cloonan YK, Kifle Y, Davis S, Speltz ML, Werler MM, Starr JR. Sleep outcomes in children with hemifacial microsomia and controls: a follow-up study. Pediatrics 2009;124(2):e313-21. doi: 10.1542/peds.2008-3488. PMCID: PMC2739665.
  • Li L, Werler MM. Fruit and vegetable intake and risk of upper respiratory tract infection in pregnant women. Public Health Nutr 2009;13(2):276-82. doi: 10.1017/S1368980009990590. PMCID: PMC2808435.
  • Werler MM, Starr JR, Cloonan YK, Speltz ML. Hemifacial microsomia: from gestation to childhood. J Craniofac Surg 2009;20(Suppl. 1):664-9. PMCID: PMC2791372.
  • Toh S, Mitchell AA, Louik C, Werler MM, Chambers CD, Hernández-Díaz S. Selective serotonin reuptake inhibitor use and risk of gestational hypertension. Am J Psychiatry 2009;166:320-8. doi: 10.1176/appi.ajp.2008.08060817. PMCID: PMC2735348.
  • Mitchell AA. Prescription medication sharing [letter to the editor]. Am J Public Health 2008;98(11):1926-7. doi: 10.2105/AJPH.2008.144261.
  • Petersen EE, Mitchell AA, Carey JC, Werler MM, Louik C, Rasmussen SA, and the National Birth Defects Prevention Study. Maternal exposure to statins and risk for birth defects: a case-series approach [research letter]. Am J Med Genet A 2008;146A(20):2701-5. doi: 10.1002/ajmg.a.32493.
  • Nelson JW, Werler MM. Socioeconomic status as a modifier of the relationship between antibiotic use during pregnancy and birthweight. Birth 2008;35(3):196-203. doi: 10.1111/j.1523-536X.2008.00240.x.
  • Toh S, Mitchell AA, Werler MM, Hernández-Díaz S. Toh et al. respond to “Compromise or compromising?” [commentary]. Am J Epidemiol 2008;167(6):644-5. doi: 10.1093/aje/kwm369.
  • Toh S, Mitchell AA, Werler MM, Hernández-Díaz S. Sensitivity and specificity of computerized algorithms to classify gestational periods in the absence of information on date of conception. Am J Epidemiol 2008;167(6):633-40. doi: 10.1093/aje/kwm367.
  • Hernández-Díaz S, Van Marter LJ, Werler MM, Louik C, Mitchell AA. Risk factors for persistent pulmonary hypertension of the newborn. Pediatrics 2007;120(2);272-82.
  • Louik C, Lin AE, Werler MM, Hernández-Díaz S, Mitchell AA. First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. N Engl J Med 2007;356:2675-83.
  • Leeder JS, Mitchell AA. Application of pharmacogenomic strategies to the study of drug-induced birth defects. Clin Pharmacol Ther 2007;81(4):595-9. 
  • Werler MM. Maternal smoking and undescended testes: reaching a tipping point [commentary]. Epidemiology 2007;18:197-8.
  • Badovinac RL, Werler MM, Williams PL, Kelsey KT, Hayes C. Folic acid-containing supplement consumption during pregnancy and risk for oral clefts: a meta-analysis. Birth Defects Res A Clin Mol Teratol 2007;79:8-15.
  • Hernández-Díaz S, Schisterman EF, Hernán MA. Hernández-Díaz et al. respond to “The perils of birth weight” [commentary]. Am J Epidemiol 2006;164:1124-5.
  • Hernández-Díaz S, Schisterman EF, Hernán MA. The birth weight “paradox” uncovered? Am J Epidemiol 2006;164:1115-20.
  • Meijer WM, Werler MM, Louik C, Hernández-Díaz S, de Jong-van den Berg LTW, Mitchell AA. Can folic acid protect against congenital heart defects in Down syndrome? Birth Defects Res A Clin Mol Teratol 2006;76(10):714-7.
  • Werler MM. Teratogen update: pseudoephedrine. Birth Defects Res A Clin Mol Teratol 2006;76(6):445-52. 
  • Louik C, Hernández-Díaz S, Werler MM, Mitchell AA. Nausea and vomiting in pregnancy: maternal characteristics and risk factors. Paediatr Perinat Epidemiol 2006;20:270-8.
  • Chambers CD, Hernández-Díaz S, Van Marter LJ, Werler MM, Louik C, Jones KL, Mitchell AA. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 2006;354(6):579-87.
  • Mitchell AA. Prone to sleep, prone to pyloric stenosis? [commentary]. Epidemiology 2006;17:136-7. 
  • Werler MM, Mitchell AA, Hernández-Díaz S, Honein MA, and the National Birth Defects Prevention Study. Use of over-the-counter medications during pregnancy. Am J Obstet Gynecol 2005;193:771-7.
  • Hernández-Díaz S, Wu XF, Hayes C, Werler MW, Ashok TDS, Badovinac R, Kelsey KT, Mitchell AA. Methylenetetrahydrofolate reductase polymorphisms and the risk of gestational hypertension. Epidemiology 2005;16(5):628-34.
  • Mitchell AA. Studies of drug-induced birth defects. In: Strom BL, ed. Pharmacoepidemiology. 4th ed. New York: Wiley, 2005:501-15.
  • Louik C, Mitchell AA. Post-marketing surveillance using pharmacy-based cohorts: results of a pilot study. Pharmacoepidemiol Drug Saf 2005;14:289-95.
  • de Jong-van den Berg LTW, Hernández-Díaz S, Werler MM, Louik C, Mitchell AA. Trends and predictors of folic acid awareness and periconceptional use in pregnant women. Am J Obstet Gynecol 2005;192:121-8.
  • Werler MM, Sheehan JE, Mitchell AA. Gulf war veterans and hemifacial microsomia. Birth Defects Res A Clin Mol Teratol 2005;73:50-2.
  • Chan KA, Hernández-Díaz S. Pharmacoepidemiology and rheumatic disorders. Rheum Dis Clin North Am 2004;30(4):835-50.
  • Meyer K, Williams P, Hernández-Díaz S, Cnattingius S. Smoking and the risk of oral clefts: exploring the impact of study designs. Epidemiology 2004;15(6):671-8.
  • Werler MM, Sheehan JE, Hayes C, Padwa BL, Mitchell AA, Mulliken JB. Demographic and reproductive factors associated with hemifacial microsomia. Cleft Palate Craniofac J 2004;41:494-500.
  • Werler MM, Sheehan JE, Hayes C, Mitchell AA, Mulliken JB. Vasoactive exposures, vascular events, and hemifacial microsomia. Birth Defects Res A Clin Mol Teratol 2004;70(6):389-95.
  • Mitchell AA. Systematic identification of drugs that cause birth defects–a new opportunity [editorial]. N Engl J Med 2003;349:2556-9.
  • Hernández-Díaz S, de Abajo FJ. Psychomotor development in children and antenatal psychotropic and anti-epileptic drugs [commentary]. Eur J Epidemiol 2003;18(8):743-4.
  • Hernández-Díaz S, Hernán MA, Meyer K, Werler MM, Mitchell AA. Case-crossover and case-time-control designs in birth defects epidemiology. Am J Epidemiol 2003;158:385-91.
  • Meyer KA, Werler MM, Hayes C, Mitchell AA. Low maternal alcohol consumption during pregnancy and oral clefts in offspring: the Slone Birth Defects Study. Birth Defects Res A Clin Mol Teratol 2003;67:509-14. 
  • Werler MM, Sheehan JE, Mitchell AA. Association of vasoconstrictive exposures with risks of gastroschisis and small intestinal atresia. Epidemiology 2003;14:349-54.
  • Louik C, Mitchell AA. Prenatal prescription of macrolide antibiotics and infantile hypertrophic pyloric stenosis [letter to the editor]. Obstet Gynecol 2003;101(4):816.
  • Waller DK, Tita ATN, Werler MM, Mitchell AA. Association between pre-pregnancy maternal body mass index and the risk of having an infant with a congenital diaphragmatic hernia. Birth Defects Res A Clin Mol Teratol 2003;67:73-6.
  • Werler MM, Louik C, Mitchell AA. Epidemiologic analysis of maternal factors and amniotic band defects. Birth Defects Res A Clin Mol Teratol 2003;67:68-72.
  • Hernández-Díaz S, Werler MM, Louik C, Mitchell AA. Risk of gestational hypertension in relation to folic acid supplementation during pregnancy. Am J Epidemiol 2002;156:806-12.
  • Werler MM. Exposure assessment in studies of oral clefts. In: Wyszynski DF, ed. Cleft lip and palate: from origin to treatment. New York: Oxford University Press, 2002:108-16.
  • Hernández-Díaz S. Iatrogenic legacy from diethylstilbestrol exposure [commentary]. Lancet 2002;359:1081-2.
  • Mitchell AA. Infertility treatment–more risks and challenges [editorial]. N Engl J Med 2002;346:769-70.
  • Louik C, Werler MM, Mitchell AA. Erythromycin use during pregnancy in relation to pyloric stenosis. Am J Obstet Gynecol 2002;186:288-90.
  • Werler MM, Sheehan JE, Mitchell AA. Maternal medication use and risks of gastroschisis and small intestinal atresia. Am J Epidemiol 2002;155:26-31.
  • Hernán MA, Hernández-Díaz S, Werler MM, Mitchell AA. Causal knowledge as a prerequisite for confounding evaluation: an application to birth defects epidemiology. Am J Epidemiol 2002;155:176-84.
  • Werler MM. Additional insights into the etiology of cardiac anomalies [editorial]. Epidemiology 2001;12:482-4.
  • Kaufman DW, Rosenberg L, Mitchell AA. Signal generation and clarification: use of case-control data. Pharmacoepidemiol Drug Saf 2001;10:197-203.
  • Hernández-Díaz S, Werler MM, Walker AM, Mitchell AA. Neural tube defects in relation to use of folic acid antagonists during pregnancy. Am J Epidemiol 2001;153:961-8. 
  • Hernández-Díaz S, Werler MM, Walker AM, Mitchell AA. Folic acid antagonists during pregnancy and the risk of birth defects. N Engl J Med 2000;343:1608-14.
  • Mitchell AA. Special considerations in studies of drug-induced birth defects. In: Strom BL, ed. Pharmacoepidemiology. 3rd ed. Chichester, UK: John Wiley and Sons, 2000:749-63.
  • Louik C, Frumkin H, Ellenbecker MJ, Goldman RH, Werler MM, Mitchell AA. Use of a job-exposure matrix to assess occupational exposures in relation to birth defects. J Occup Environ Med 2000;42:693-703.
  • Werler MM, Mitchell AA. Folic acid and neural tube defect risk [letter to the editor]. N Engl J Med 2000;342:1135-6.
  • Werler MM, Louik C, Mitchell AA. Achieving a public health recommendation for preventing neural tube defects with folic acid. Am J Public Health 1999;89:1637-40.
  • Lieff S, Olshan AF, Werler M, Strauss RP, Smith J, Mitchell A. Maternal cigarette smoking during pregnancy and risk of oral clefts in newborns. Am J Epidemiol 1999;150:683-94.
  • Werler MM, Hayes C, Louik C, Shapiro S, Mitchell AA. Multivitamin supplementation and risk of birth defects. Am J Epidemiol 1999;150:675-82.
  • Lieff S, Olshan AF, Werler M, Savitz DA, Mitchell AA. Selection bias and the use of controls with malformations in case-control studies of birth defects. Epidemiology 1999;10:238-41.
  • Mitchell AA. Intracytoplasmic sperm injection: offering hope for a term pregnancy and a healthy child? [editorial]. BMJ 1997;315:1245-6.
  • Werler MM. Teratogen update: smoking and reproductive outcomes. Teratology 1997;55:382-8.
  • Werler MM, Cragan JD, Wasserman CR, Shaw GM, Erickson JD, Mitchell AA. Multivitamin supplementation and multiple births. Am J Med Genet 1997;71:93-6.
  • Hayes C, Werler MM, Willett WC, Mitchell AA. Case-control study of periconceptional folic acid supplementation and oral clefts. Am J Epidemiol 1996;143:1229-34.
  • Werler MM, Louik C, Shapiro SS, Mitchell AA. Prepregnant weight in relation to risk of neural tube defects. J Am Med Assoc 1996;275:1089-92.
  • Werler MM, Mitchell AA. More on folic acid and neural tube defects [letter to the editor]. Am J Public Health 1995;85:269.
  • Mitchell AA, Werler MM, Shapiro S. Response to the commentary “Should we consider a subject’s knowledge of the etiologic hypothesis in the analysis of case-control studies?” [commentary]. Am J Epidemiol 1995;141:297-8.
  • Mitchell AA. Special considerations in studies of drug-induced birth defects. In: Strom BL, ed. Pharmacoepidemiology. 2nd ed. Chichester, UK: John Wiley and Sons, 1994:595-608.
  • Werler MM, Louik C, Shapiro S, Mitchell AA. Ovulation induction and risk of neural tube defects. Lancet 1994;344:445-6.
  • Werler MM, Mitchell AA. Case-control study of vitamin supplementation and neural tube defects: consideration of potential confounding by lifestyle factors. Ann N Y Acad Sci 1993;678:276-83.
  • Werler MM, Shapiro S, Mitchell AA. Periconceptional folic acid exposure and risk of occurrent neural tube defects. J Am Med Assoc 1993;269:1257-61.
  • Mitchell AA, Werler MM, Shapiro S. Analyses and reanalyses of epidemiologic data: learning lessons and maintaining perspective [commentary]. Teratology 1992;46:209-11.
  • Werler MM, Mitchell AA, Shapiro S. First trimester maternal medication use in relation to gastroschisis. Teratology 1992;45:361-7.
  • Werler MM, Mitchell AA, Shapiro S. Demographic, reproductive, medical, and environmental factors in relation to gastroschisis. Teratology 1992;45:353-60.
  • Mitchell AA. Oral retinoids: what should the prescriber know about their teratogenic hazards among women of child-bearing potential? Drug Saf 1992;7:79-85.
  • Werler MM, Lammer EJ, Rosenberg L, Mitchell AA. Maternal alcohol use in relation to selected birth defects. Am J Epidemiol 1991;134:691-8. 
  • Mitchell AA. Teratogens and the dermatologist: new knowledge, responsibilities, and opportunities [editorial]. Arch Dermatol 1991;127:399-401.
  • Werler MM, Lammer EJ, Rosenberg L, Mitchell AA. Maternal vitamin A supplementation in relation to selected birth defects. Teratology 1990;42:497-503.
  • Werler MM, Lammer EJ, Rosenberg L, Mitchell AA. Maternal cigarette smoking during pregnancy in relation to oral clefts. Am J Epidemiol 1990;132:926-32.
  • Werler MM, Mitchell AA, Shapiro S. The relation of aspirin use during the first trimester of pregnancy to congenital cardiac defects. N Engl J Med 1989;321:1639-42.
  • Mitchell AA. Slone Epidemiology Unit Birth Defects Study. Genetic Resour 1988;4:31-2.
  • Louik C, Mitchell A, Werler M, Hanson J, Shapiro S. Maternal exposure to spermicides in relation to certain birth defects. N Engl J Med 1987;317:474-8.
  • Mitchell AA, Cottler LB, Shapiro S. Effect of questionnaire design on recall of drug exposure in pregnancy. Am J Epidemiol 1986;123:670-6.
  • Mitchell AA, Schwingl PJ, Rosenberg L, Louik C, Shapiro S. Birth defects in relation to Bendectin use in pregnancy: pyloric stenosis. Am J Obstet Gynecol 1983;147:737-42.
  • Rosenberg L, Mitchell AA, Parsells J, Pashayan H, Louik C, Shapiro S. Lack of relation of oral clefts to diazepam use during pregnancy. N Engl J Med 1983;309:1282-5.
  • Shapiro S, Slone D, Heinonen OP, Kaufman DW, Rosenberg L, Mitchell AA, Helmrich SP. Birth defects and vaginal spermicides. J Am Med Assoc 1982;247:2381-4.
  • Rosenberg L, Mitchell AA, Shapiro S, Slone D. Selected birth defects in relation to caffeine-containing beverages. J Am Med Assoc 1982;247:1429-32.
  • Mitchell AA, Rosenberg L, Shapiro S, Slone D. Birth defects related to Bendectin use in pregnancy: oral clefts and cardiac defects. J Am Med Assoc 1981;245:2311-4.
  • Slone D, Shapiro S, Mitchell AA. Strategies for studying the effects of the antenatal chemical environment on the fetus. In: Schwarz RH, Yaffe SJ, eds. Drug and chemical risks to the fetus and newborn. New York: Alan R. Liss, Inc., 1980.

Carla Van Bennekom, M.P.H.
(617) 206-6198

cvanben@bu.edu