Centers for Excellence in Birth Defects Research and Prevention

The Slone Epidemiology Center is participating in the Massachusetts Center for Birth Defects Research and Prevention, one of seven such centers currently funded by the National Center on Birth Defects and Developmental Disabilities (CDC). These centers conduct surveillance and research aimed at the prevention of birth defects. The Center’s work includes two national case-control studies to identify risk factors for birth defects. The first, conducted between 1997 and 2013, was called the National Birth Defects Prevention Study (NBDPS). It was followed in 2014 by the Birth Defects Study to Evaluate Pregnancy Exposures (BD-STEPS). Only well-defined major defects with unknown or uncertain etiology are included. Slone’s role involves overall planning and conduct of the Massachusetts Center, participation in the design and analysis of the national study, and conduct of birth defect research that is not part of the national study but contributes to the centers’ objectives.

Investigators:

Marlene Anderka, M.P.H., Principal Investigator
Massachusetts Department of Public Health

Allen A. Mitchell, M.D., Co-Investigator
Slone Epidemiology Center

Lewis Holmes, M.D., Co-Investigator
Massachusetts General Hospital

Study Staff:

Martha M. Werler, Sc.D., Epidemiologist
Carla van Bennekom, M.P.H., Epidemiologist
Stephen Kerr, M.P.H., Data Analyst

Source of Funding:

Centers for Disease Control and Prevention, through the Massachusetts Department of Public Health

Study Period:

1996 to present

  • Chambers C, Johnson D, Xu R, Luo Y, Louik C, Mitchell AA, Schatz M, Jones KL, and the OTIS Collaborative Research Group. Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine (in press).
  • Vuong AM, Shinde MU, Brender JD, Shipp EM, Huber JC Jr, Sharkey JR, McDonald TJ, Werler MM, Kelley KE, Griesenbeck JS, Langlois PH, Canfield MA, and the National Birth Defects Prevention Study Investigators. Prenatal exposure to nitrosatable drugs, dietary intake of nitrites, and preterm births. Am J Epidemiol 2016;183(7):634-42. doi: 10.1093/aje/kwv250.
  • Louik C, Werler MM, Anderka M, Mitchell AA. Application of data screening to drug exposure in large risk factor studies of birth defects. Birth Defects Res A Clin Mol Teratol 2015;103(8):713-7. doi: 10.1002/bdra.23407.
  • Yazdy MM, Werler MM, Feldkamp ML, Shaw GM, Mosley BS, Vieirae VM, and The National Birth Defects Prevention Study. Spatial analysis of gastroschisis in the National Birth Defects Prevention Study. Birth Defects Res A Clin Mol Teratol 2015;103(6):544-53. doi: 10.1002/bdra.23375. PMCID: PMC4478213.
  • Dodge LE, Kelley KE, Williams PL, Williams MA, Herńandez-D́iaz S, Missmer SA, Hauser R. Medications as a source of paraben exposure. Reprod Toxicol 2015;52:93-100. doi: 10.1016/j.reprotox.2015.02.002.
  • Yazdy MM, Mitchell AA, Louik C, Werler MM. The authors respond [letter to the editor]. Epidemiology 2015;26(3):e35-6. doi: 10.1097/EDE.0000000000000281. PMCID: PMC4388046.
  • Yazdy MM, Werler MM, Langlois PH, Anderka M, Vieira VM. Spatial analysis of gastroschisis in Massachusetts and Texas. Ann Epidemiol 2015;25(1):7-14. doi: 10.1016/j.annepidem.2014.10.001.
  • Vuong AM, Shinde MU, Brender JD, Shipp EM, Huber Jr JC, Zheng Q, McDonald TJ, Sharkey JR, Hoyt AT, Werler MM, Kelley KE, Langlois PH, Canfield MA, and the National Birth Defects Prevention Study. Nitrosatable drug exposure during pregnancy and preterm and small-for-gestational-age births. Paediatr Perinat Epidemiol 2015;29(1):60-71. doi: 10.1111/ppe.12169.
  • Werler MM, Yazdy MM, Kasser JR, Mahan ST, Meyer RE, Anderka M, Druschel CM, Mitchell AA. Maternal cigarette, alcohol, and coffee consumption in relation to risk of clubfoot. Paediatr Perinat Epidemiol 2015;29(1):3-10. doi: 10.1111/ppe.12163. PMCID: PMC Journal – In Process.
  • Parker SE, Starr JR, Collett BR, Speltz ML, Werler MM. Nausea and vomiting during pregnancy and neurodevelopmental outcomes in offspring. Paediatr Perinat Epidemiol 2014;28(6):527-35. doi: 10.1111/ppe.12151. PMCID: PMC4232991.
  • Yazdy MM, Mitchell AA, Louik C, Werler MM. Use of selective serotonin-reuptake inhibitors during pregnancy and the risk of clubfoot. Epidemiology 2014;25(6):859-65. doi: 10.1097/EDE.0000000000000157. PMCID: PMC4180776.
  • Werler MM, Yazdy MM, Kasser JR, Mahan ST, Meyer RE, Anderka M, Druschel CM, Mitchell AA. Medication use in pregnancy in relation to the risk of isolated clubfoot in offspring. Am J Epidemiol 2014;180(1):86-93. doi: 10.1093/aje/kwu096. PMCID: PMC4133556.
  • Van Bennekom CM, Mitchell AA. Comments on: Are Food and Drug Administration prescription drug safety plans working? A case study of isotretinoin [letter to the editor]. Pharmacoepidemiol Drug Saf 2014;23(4):439. doi: 10.1002/pds.3573.
  • Mahan ST, Yazdy MM, Kasser JR, Werler MM. Prenatal screening for clubfoot: what factors predict prenatal detection? Prenat Diagn 2014;34(4):389-93. doi: 10.1002/pd.4320. PMCID: PMC4028147.
  • Van Zutphen AR, Werler MM, Browne MM, Romitti PA, Bell EM, McNutt LA, Druschel CM, Mitchell AA, and the National Birth Defects Prevention Study. Maternal hypertension, medication use, and hypospadias in the National Birth Defects Prevention Study. Obstet Gynecol 2014;123(2):309-17. doi: 10.1097/AOG.0000000000000103.
  • Browne ML, Van Zutphen AR, Botto LD, Louik C, Richardson S, Druschel CM. Maternal butalbital use and selected defects in the National Birth Defects Prevention Study. Headache 2014;54(1):54-66. doi: 10.1111/head.12203.
  • Caspers KM, Romitti PA, Lin S, Olney RS, Holmes LB, Werler MM, and the National Birth Defects Prevention Study. Maternal periconceptional exposure to cigarette smoking and congenital limb deficiencies. Paediatr Perinat Epidemiol 2013;27(6):509-20. doi: 10.1111/ppe.12075.
  • Mahan ST, Yazdy MM, Kasser JR, Werler MM. Is it worthwhile to routinely ultrasound screen children with idiopathic clubfoot for hip dysplasia? J Pediatr Orthop 2013;33(8):847-51. doi: 10.1097/BPO.0000000000000100. PMCID: PMC4574100.
  • 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.
  • Ahrens KA, Anderka MT, Feldkamp ML, Canfield MA, Mitchell AA, Werler MM, and the National Birth Defects Prevention Study. Antiherpetic medication use and the risk of gastroschisis: findings from the National Birth Defects Prevention Study, 1997-2007. Paediatr Perinat Epidemiol 2013;27(4):340-5. doi: 10.1111/ppe.12064. PMCID: PMC3690801.
  • Brender JD, Weyer PJ, Romitti PA, Mohanty BP, Shinde MU, Vuong AM, Sharkey JR, Dwivedi D, Horel SA, Kantamneni J, Huber Jr JC, Zheng Q, Werler MM, Kelley KE, Griesenbeck JS, Zhan FB, Langlois PH, Suarez L, Canfield MA, and the National Birth Defects Prevention Study. Prenatal nitrate intake from drinking water and selected birth defects in offspring of participants in the National Birth Defects Prevention Study. Environ Health Perspect 2013;121(9):1083-9. doi: 10.1289/ehp.1206249.
  • Shinde MU, Vuong AM, Brender JD, Werler MM, Kelley KE, Huber JC, Sharkey JR, Zheng Q, Suarez L, Langlois PH, Canfield MA, Romitti PA, Malik S, and the National Birth Defects Prevention Study. Prenatal exposure to nitrosatable drugs, vitamin C, and risk of selected birth defects. Birth Defects Res A Clin Mol Teratol 2013;97(8):515-31. doi: 10.1002/bdra.23137.
  • Werler MM, Yazdy MM, Mitchell AA, Meyer RE, Druschel CM, Anderka M, Kasser JR, Mahan ST. Descriptive epidemiology of idiopathic clubfoot. Am J Med Genet A 2013;161(7):1569-78. doi: 10.1002/ajmg.a.35955. PMCID: PMC3689855.
  • Tinker SC, Gibbs C, Devine O, Crider K, Werler MM, Anderka M, Reefhuis J, and the National Birth Defects Prevention Study. Impact of time to maternal interview on interview responses in the National Birth Defects Prevention Study. Am J Epidemiol 2013;177(11):1225-35. doi: 10.1093/aje/kws352.
  • Lind JN, Tinker SC, Broussard CS, Reefhuis J, Carmichael SL, Honein MA, Olney RS, Parker SE, Werler MM, and the National Birth Defects Prevention Study. Maternal medication and herbal use and risk for hypospadias: data from the National Birth Defects Prevention Study, 1997-2007. Pharmacoepidemiol Drug Saf 2013;22(7):783-93. doi: 10.1002/pds.3448.
  • Van Bennekom CM, Mitchell AA, Moore CA, Werler MM, and the National Birth Defects Prevention Study. Vasoactive exposures during pregnancy and risk of microtia. Birth Defects Res A Clin Mol Teratol 2013;97(1):53-9. doi: 10.1002/bdra.23101.
  • Cloonan YK, Collett B, Speltz ML, Anderka A, Werler MM. Psychosocial outcomes in children with and without non-syndromic craniosynostosis: findings from two studies. Cleft Palate Craniofac J 2013;50(4):406-13. doi: 10.1597/11-074.
  • Parker SE, Werler MM, Shaw GM, Anderka M, Yazdy MM, and the National Birth Defects Prevention Study. Dietary glycemic index and the risk of birth defects. Am J Epidemiol 2012;176(12):1110–20. doi: 10.1093/aje/kws201.
  • Getz KD, Anderka MT, Werler MM, Case AP. Short interpregnancy interval and gastroschisis risk in the National Birth Defects Prevention Study. Birth Defects Res A Clin Mol Teratol 2012;94:714-20. doi: 10.1002/bdra.23061.
  • Brender JD, Werler MM, Shinde MU, Vuong AM, Kelley KE, Huber Jr JC, Sharkey JR, Griesenbeck JS, Romitti PA, Malik S, Suarez L, Langlois PH, Canfield MA, and the National Birth Defects Prevention Study. Nitrosatable drug exposure during the first trimester of pregnancy and selected congenital malformations. Birth Defects Res A Clin Mol Teratol 2012;94:701-13. doi: 10.1002/bdra.23060.
  • 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.
  • Barger MK, Nannini A, Weiss J, Declercq ER, Stubblefield P, Werler MM, Ringer S. Severe maternal and perinatal outcomes from uterine rupture among women at term with a trial of labor. J Perinatol 2012;32(11):837-43. doi: 10.1038/jp.2012.2.
  • Hernandez RK, Werler MM, Romitti P, Sun L, Anderka M, and the National Birth Defects Prevention Study. Nonsteroidal antiinflammatory drug use among women and the risk of birth defects. Am J Obstet Gynecol 2012;206(3):228.e1-8. doi: 10.1016/j.ajog.2011.11.019.
  • Anderka M, Mitchell AA, Louik C, Werler MM, Hernández-Díaz S, Rasmussen SA, and the National Birth Defects Prevention Study. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol 2012;94(1):22-30. doi: 10.1002/bdra.22865. PMCID: PMC3299087.
  • Burris HH, Werler MM. U.S. provider reported folic acid or multivitamin ordering for non-pregnant women of childbearing age: NAMCS and NHAMCS, 2005-2006. Matern Child Health J 2011;15(3):352-9. doi: 10.1007/s10995-010-0587-6.
  • Brender JD, Werler MM, Kelley KE, Vuong AM, Shinde MU, Zheng Q, Huber JC, Sharkey JR, Griesenbeck JS, Romitti PA, Langlois PH, Suarez L, Canfield MA, and the National Birth Defects Prevention Study. Nitrosatable drug exposure during early pregnancy and neural tube defects in offspring. Am J Epidemiol 2011;174(11):1286-95. doi: 10.1093/aje/kwr254.
  • Werler MM, Ahrens KA, Bosco JLF, Mitchell AA, Anderka MT, Gilboa SM, Holmes LB, and the National Birth Defects Prevention Study. Use of antiepileptic medications in pregnancy in relation to risks of birth defects. Ann Epidemiol 2011;21:842-50. doi: 10.1016/j.annepidem.2011.08.002.
  • Barger MK, Weiss J, Nannini A, Werler MM, Heeren T, Stubblefield PG. Risk factors for uterine rupture among women who attempt a vaginal birth after a previous Cesarean: a case-control study. J Reprod Med 2011;56(7-8):313-20.
  • 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.
  • Brender JD, Kelley KE, Werler MM, Langlois PH, Suarez L, Canfield MA, and the National Birth Defects Prevention Study. Prevalence and patterns of nitrosatable drug use among U.S. women during early pregnancy. Birth Defects Res A Clin Mol Teratol 2011;91:258-64.
  • 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.
  • Carter TC, Olney RS, Mitchell AA, Romitti PA, Bell EM, Druschel CM, and the National Birth Defects Prevention Study. Maternal self-reported genital tract infections during pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol 2011;91:108-16.
  • van Gelder MM, Reefhuis J, Caton AR, Werler MM, Druschel CM, Roeleveld N, and the National Birth Defects Prevention Study. Characteristics of pregnant illicit drug users and associations between cannabis use and perinatal outcome in a population-based study. Drug Alcohol Depend 2010;109:243-7. doi: 10.1016/j.drugalcdep.2010.01.007.
  • 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.
  • Broussard CS, Louik C, Honein MA, Mitchell AA. Herbal use before and during pregnancy. Am J Obstet Gynecol 2010;202:443.e1-6. doi: 10.1016/j.ajog.2009.10.865.
  • Waller DK, Gallaway MS, Shayne M, Taylor LG, Ramadhani TA, Canfield MA, Scheuerle A, Hernández-Díaz S, Louik C, Correa A, and the National Birth Defects Prevention Study. Use of oral contraceptives in pregnancy and major structural birth defects in offspring. Epidemiology 2010;21(2):232-9. doi: 10.1097/EDE.0b013e3181c9fbb3.
  • van Gelder M, Reefhuis J, Caton A, Werler MM, Druschel C, Roeleveld N, and the National Birth Defects Prevention Study. Maternal periconceptional illicit drug use and the risk of congenital malformations. Epidemiology 2009;20(1):60-6. doi: 10.1097/EDE.0b013e31818e5930.
  • Carmichael SL, Ma C, Werler MM, Olney RS, Shaw GM, and the National Birth Defects Prevention Study. Maternal corticosteroid use and hypospadias. J Pediatr 2009;155(1):39-44.e1. doi: 10.1016/j.jpeds.2009.01.039. PMCID: PMC2764545.
  • Anderka MT, Lin AE, Abuelo DN, Mitchell AA, Rasmussen SA. Reviewing the evidence for mycophenolate mofetil as a new teratogen: case report and review of the literature. Am J Med Genet A 2009;149A(6):1241-8. doi: 10.1002/ajmg.a.32685.
  • Werler MM, Bosco JLF, Shapira SK, and the National Birth Defects Prevention Study. Maternal vasoactive exposures, amniotic bands, and terminal transverse limb defects. Birth Defects Res A Clin Mol Teratol 2009;85:52-7. doi: 10.1002/bdra.20524. PMCID: PMC2741326.
  • Werler MM, Mitchell AA, Moore CA, Honein MA, and the National Birth Defects Prevention Study. Is there epidemiologic evidence to support vascular disruption as a pathogenesis of gastroschisis?. Am J Med Genet 2009;149A(7):1399-406. doi: 10.1002/ajmg.a.32897. PMCID: PMC2739090.
  • Hernández-Díaz S, Mitchell AA, Kelley KE, Calafat AM, Hauser R. Medications as a potential source of exposure to phthalates in the U.S. population. Environ Health Perspect 2009;117(2):185-9. doi: 10.1289/ehp.11766. PMCID: PMC2649218.
  • Caton AR, Bell EM, Druschel CM, Werler MM, Lin AE, Browne ML, McNutt LA, Romitti PA, Mitchell AA, Olney RS, Correa A, and the National Birth Defects Prevention Study. Antihypertensive medication use during pregnancy and the risk of cardiovascular malformations. Hypertension 2009;54(1):63-70. doi: 10.1161/HYPERTENSIONAHA.109.129098.
  • Gilboa SM, Strickland MJ, Olshan AF, Werler MM, Correa A, and the National Birth Defects Prevention Study. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 2009;85(2):137-50. doi: 10.1002/bdra.20513.
  • Mosley BS, Cleves MA, Siega-Riz AM, Shaw GM, Canfield MA, Waller DK, Werler MM, Hobbs CA, and the National Birth Defects Prevention Study. Neural tube defects and maternal folate intake among pregnancies conceived after folic acid fortification in the United States. Am J Epidemiol 2009;169(1):9-17. doi: 10.1093/aje/kwn331.
  • 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.
  • Bitsko RH, Reefhuis J, Louik C, Werler MM, Feldkamp ML, Waller DK, Frias J, Honein MA, and the National Birth Defects Prevention Study. Periconceptional use of weight loss products including Ephedra and the association with birth defects. Birth Defects Res A Clin Mol Teratol 2008;82(8):553-62.
  • Carter TC, Druschel CM, Romitti PA, Bell EM, Werler MM, Mitchell AA, and the National Birth Defects Prevention Study. Antifungal drugs and the risk of selected birth defects. Am J Obstet Gynecol 2008;198:191.e1-7. doi: 10.1016/j.ajog.2007.08.044.
  • Caton AR, Bell EM, Druschel CM, Werler MM, Mitchell AA, Browne ML, McNutt LA, Romitti PA, Olney RS, Correa A, and the National Birth Defects Prevention Study. Maternal hypertension, antihypertensive medication use, and the risk of severe hypospadias. Birth Defects Res A Clin Mol Teratol 2008;82(1):34-40.
  • Carmichael SL, Shaw GM, Ma C, Werler MM, Rasmussen SA, Lammer EJ, and the National Birth Defects Prevention Study. Maternal corticosteroid use and orofacial clefts. Am J Obstet Gynecol 2007;197(6):585.e1-7. doi: 10.1016/j.ajog.2007.05.046.
  • Shaw GM, Carmichael SL, Laurent C, Louik C, Finnell RH, Lammer EJ, and the National Birth Defects Prevention Study. Nutrient intakes in women and risks of anophthalmia and microphthalmia in their offspring. Birth Defects Res A Clin Mol Teratol 2007;79(10):708-13. doi: 10.1002/bdra.20398.
  • Browne M, Bell EM, Druschel CM, Gensburg LJ, Mitchell AA, Lin AE, Romitti PA, Correa A, and the National Birth Defects Prevention Study. Maternal caffeine consumption and risk of cardiovascular malformations. Birth Defects Res A Clin Mol Teratol 2007;79(7):533-43.
  • Cooper WO, Hernández-Díaz S, Arbogast PG, Dudley JA, Dyer S, Gideon PS, Hall K, Ray WA. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med 2006;354(23):2443-51.
  • Siega-Riz AM, Olshan AF, Werler MM, Moore C and the National Birth Defects Prevention Study. Fat intake and the risk of gastroschisis. Birth Defects Res A Clin Mol Teratol 2006;76(4):241-5.
  • 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.
  • Anderson JL, Waller DK, Canfield MA, Shaw GM, Watkins ML, Werler MM. Maternal obesity, gestational diabetes, and central nervous system birth defects. Epidemiology 2005;16(1):87-92.
  • Werler MM, McCloskey C, Edmonds LD, Olney R, Honein MA, Reefhuis J, and the National Birth Defects Prevention Study. Evaluation of an association between loratadine and hypospadias–United States, 1997-2001. MMWR 2004;53(10):219-21.
  • Cleves MA, Savell VH, Raj S, Zhao W, Correa A, Werler MM, Hobbs CA, and the National Birth Defects Prevention Study. Maternal use of acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDS), and muscular ventricular septal defects. Birth Defects Res A Clin Mol Teratol 2004;70:107-13.
  • Werler MM, Bower C, Payne J, Serna P. Findings on potential teratogens from a case-control study in Western Australia. Aust N Z J Obstet Gynaecol 2003;43(6):443-7.