Past Studies

MotherToBaby research findings contribute significantly to the field of teratogenesis, which is the study of how birth defects develop. Our investigators present their research results yearly at numerous national scientific meetings and have a number of scientific publications in top peer reviewed journals. View our completed studies and publications below.

  • Asthma Medications
  • Hurricane Katrina Project
  • Isotretinoin Survey
  • Vaccines

OTIS Asthma Medications in Pregnancy Project

The purpose of the OTIS Asthma Medications in Pregnancy Project was to investigate the effects of asthma and the treatment of asthma during pregnancy. The study was coordinated at the University of California, San Diego and was open for enrollment between 1998 and 2003. During this time, approximately 1100 women enrolled into the study. Several papers and abstracts have been published from this data and additional information continues to be published (see our publications below). If you participated in this study and you have questions about your participation please contact the Study Manager toll-free: 1-877-311-8972.

Hurricane Katrina Project

The purpose of the Hurricane Katrina project was to address specific concerns for pregnant and breastfeeding women about the effects of certain exposures (such as infections, chemicals, medications, and stress) on their fetus or breastfed child. The Organization of Teratology Information Specialists (OTIS) and the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention (CDC) partnered to provide information for women and health professionals about the effects of exposures on pregnancy and breastfeeding following the hurricanes of 2005. This project expanded on OTIS’s existing telephone counseling and fact sheets, which were created to address specific potential concerns regarding exposures following the hurricanes. In addition, the OTIS national toll-free telephone number was modified to accommodate questions regarding hurricane-related exposures and several strategies were used to publicize this number as a resource for obtaining hurricane-related exposure information related to pregnancy and breastfeeding. A description of OTIS’s response after the hurricanes, the challenges encountered in implementing the response, and lessons learned that might be useful to improve the response to the unique needs of this special population following any disaster or public health emergency have been published (see our Publication list below).

Isotretinoin Survey

The iPLEDGE™ Risk-Management System is a pregnancy prevention program approved by the FDA in August 2005. Under this system, wholesalers, pharmacies, prescribers and patients all must agree to the requirements of the risk-management system in order to obtain isotretinoin. In the Isotretinoin Survey, OTIS explored the success of the iPLEDGE™ program by monitoring the calls its member services received from women who became pregnant while taking isotretinoin. The survey is now closed and the results of this study have now been published. For details of this and all published OTIS studies see our (see our Publication list below).

OTIS Vaccines in Pregnancy Pilot Project

The purpose of the OTIS Vaccines in Pregnancy Pilot Project was to work collaboratively with the Slone Epidemiology Center at Boston University to 1) demonstrate the feasibility of identifying exposures to vaccines in pregnancy, 2) determine the most effective and efficient method for identifying brand of vaccine administered during pregnancy, and 3) collect pregnancy outcome information on womens’ exposure to specific vaccines during pregnancy. This pilot project enrolled women between September 2006 through February 2008 and was coordinated at the University of California, San Diego. Preliminary results of this study were presented at the Teratology Society meeting in June 2008. Chambers CD, Johnson DL, Jones KL. Methods of Validating Exposure to Vaccines in Pregnancy: The OTIS Vaccines in Pregnancy Pilot Project. 2008. Birth Defects Research (Part A) 82: 341.

Publications From Our Research Team

ADD/ADHD Medications

Diav-Citrin O, Shechtman S, Arnon J, Wajnberg R, Borisch C, Beck E, Richardson JL, Bozzo P, Nulman I, Ornoy A. Methylphenidate in pregnancy: a multicenter, prospective, observational study. J Clin Psychiatry 2016 Sep;77(9):1176-1181. For more information, visit


Einarson A, Phillips E, Mawji F, D’Alimonte D, Schick B, Addis A, Mastroiacova P, Mazzone T, Matsui D, Koren G. 1998. A prospective controlled multicentre study of clarithromycin in pregnancy. Am. J. Perinatol. 15:523-525.

Loebstein R, Addis A, Ho E, Andreou R, Sage S, Donnenfeld AE, Schick B, Bonati M, Moretti M, Lalkin A, Pastuszak AL, Koren G. 1998. Pregnancy Outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study. Antimicrob. Agents Chemother. 42:1336-1339.

Asthma and Asthma Medications

Bakhireva LN, Schatz M, Jones KL, Chambers CD; Organization of Teratology Information Specialists Collaborative Research Group. Asthma control during pregnancy and the risk of preterm delivery or impaired fetal growth. Ann Allergy Asthma Immunol. 2008 Aug;101(2):137­43. doi: 10.1016/S1081­1206(10)60201­3.

Bakhireva LN, Schatz M, Jones KL, Tucker CM, Slymen DJ, Klonoff­Cohen HS, Gresham L, Johnson D, Chambers CD; OTIS Collaborative Research Group. Fetal sex and maternal asthma control in pregnancy. J Asthma. 2008 Jun;45(5):403­7. doi: 10.1080/02770900801971826.

Bakhireva LN, Jones KL, Schatz M, Klonoff-Cohen HS, Johnson D, Slymen DJ, Chambers CD; Organization of Teratology Information Specialists Collaborative Research Group. Safety of leukotriene receptor antagonists in pregnancy. J Allergy Clin Immunol. 2007 Mar;119(3):618­25.

Bakhireva LN, Jones KL, Schatz M, Johnson D, Chambers CD, and the Organization of Teratology Information Services Research Group. 2005. “Asthma Medication Use in Pregnancy and Fetal Growth.” J. Allergy Clin Immunol, 116:3, 503-9.

Autoimmune Diseases and Medications

Bharti B, Lee SJ, Lindsay SP, Wingard DL, Jones KL, Lemus H, Chambers CD. Disease Severity and Pregnancy Outcomes in Women with Rheumatoid Arthritis: Results from the Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project. J Rheumatol. 2015 Aug;42(8):1376­82. doi: 10.3899/jrheum.140583. Epub 2015 Apr 15.

Weber­Schoendorfer C, Chambers C, Wacker E, Beghin D, Bernard N; Network of French Pharmacovigilance Centers, Shechtman S, Johnson D, Cuppers­Maarschalkerweerd B, Pistelli A, Clementi M, Winterfeld U, Eleftheriou G, Pupco A, Kao K, Malm H, Elefant E, Koren G, Vial T, Ornoy A, Meister R, Schaefer C. Pregnancy outcome after methotrexate treatment for rheumatic disease prior to or during early pregnancy: a prospective multicenter cohort study. Arthritis Rheumatol. 2014 May;66(5):1101­10. doi: 10.1002/art.38368.

Chambers CD, Johnson DL, Robinson LK, Braddock SR, Xu R, Lopez-Jimenez J, Mirrasoul N, Salas E, Luo YJ, Jin S, Jones KL. Birth outcomes in women who have taken leflunomide during pregnancy. Arthritis Rheum. May 2010; 62(5): 1494-503.

Chambers CD, Johnson DL, Macaraeg GR, Jones KL. 2004 Pregnancy Outcome Following Early Gestational Exposure to Leflunomide: The Otis Rheumatoid Arthritis in Pregnancy Study (104). Pharmacoepidemiology and Drug Safety, 13: S1–S334.

Chambers CD, Johnson DL, Jones KL, The OTIS Collaborative Research Group. 2004. Pregnancy Outcome in Women Exposed to Anti-TNF-alpha Medications: The OTIS Rheumatoid Arthritis in Pregnancy Study. Arthritis and Rheumatism 50(9).

Blood Pressure Medications / Anti-Hypertensives

Feldkamp ML, Jones KL, Ornoy A, Pastuszak AL, Rosenwasser S, Schick B, Bar J, and Tiqva P. 1997.Postmarketing Surveillance for Angiotensin-Converting Enzyme Inhibitor Use During the First Trimester of Pregnancy-United States, Canada and Israel. 1987-1995. MMWR 46:11:240-242.

Gastroesophageal Reflux Disease (GERD) Medications

Bailey B, Addis A, Lee A,Sanghvi K, Mastroiacovo P, Mazzone T, Bonati M, Paolini C, Garbis H, Val T, DeSouza CF, Matsui D, Schechtman AS, Conover B, Lau M, Koren G. 1997. Cisapride use during human pregnancy: a prospective, controlled multicenter study. Dig. Dis. Sci. 42:1848-52.

Infections and Vaccines

Xu R, Luo Y, Glynn R, Johnson D, Jones KL, Chambers C. Time-­dependent propensity score for assessing the effect of vaccine exposure on pregnancy outcomes through pregnancy exposure cohort studies. Int J Environ Res Public Health. 2014 Mar 12;11(3):3074­85. doi: 10.3390/ijerph110303074.

Chambers CD, Johnson D, Xu R, Luo Y, Louik C, Mitchell AA, Schatz M, Jones KL; 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 Oct 17;31(44):5026­32. doi: 10.1016/j.vaccine.2013.08.097. Epub 2013 Sep 7.

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 Oct 17;31(44):5033­40. doi: 10.1016/j.vaccine.2013.08.096. Epub 2013 Sep 7.

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 Jan;22(1):33-9. doi: 10.1002/pds.3336. Epub 2012 Aug 17.

Gorman JR, Brewer NT, Wang JB, Chambers CD. Theory-based predictors of influenza vaccination among pregnant women. Vaccine. 2012 Dec 17;31(1):213-8. doi: 10.1016/j.vaccine.2012.10.064. Epub 2012 Oct 30.

Xu R, Luo Y, Chambers C. Assessing the effect of vaccine on spontaneous abortion using time-dependent covariates Cox models. Pharmacoepidemiol Drug Saf. 2012 Aug;21(8):844-50. doi: 10.1002/pds.3301. Epub 2012 Jun 4.

Schatz M, Chambers CD, Jones KL, Louik C, Mitchell AA. Safety of influenza immunizations and treatment during pregnancy: the Vaccines and Medications in Pregnancy Surveillance System. Am J Obstet Gynecol. 2011 Jun;204(6 Suppl 1):S64-8. doi: 10.1016/j.ajog.2011.01.047. Epub 2011 Feb 18.

Pastuszak AL, Levy M, Schick B, Zuber C, Feldkamp ML, Gladstone J, Bar-Levy F, Jackson E, Donnenfeld A, Meschino W, Koren G. 1994. Outcome after maternal varicella infection in the first 20 weeks of pregnancy. N. Engl. J. Med. 330:901-905.


Robertson J, Polifka JE, Avner M, Chambers C, Delevan G, Koren G, Lavigne SV, Martinez LP, Miller RK, Carey JC. 2005. A survey of pregnant women using isotretinoin. Birth Defects Res A Clin Mol Teratol, 73(11):881-7.

Mental Health Medications

Karam F, Sheehy O, Huneau MC, Chambers C, Fraser WD, Johnson D, Kao K, Martin BZ, Riordan SH, Roth M, St-André M, Lavigne SV, Wolfe L, Bérard A. The ASQ and R-PDQ Telephone- Administered Validation Within the OTIS Antidepressant in Pregnancy Study. Psychol Assess. 2015 May 4. [Epub ahead of print]

Einarson A, Fatoye B, Sarkar M, Lavigne S, Brochu J, Chambers C, Mastroiacovo P, Addis A, Matsui D, Schuler L, Einarson T, Foren G. 2001. Pregnancy Outcome Following Gestational Exposure to Venlafaxine: A Multicenter Prospective Controlled Study. Am J Psychiatry 158:1728-1730.

Pastuszak AL, Schick-Boschetto B, Zuber C, Feldkamp ML, Pinelli M, Sihn S, Donnenfeld A, McCormack M, Leen-Mitchell M, Woodland C, Gardner A, Horn G, Koren G. 1993. Pregnancy Outcome following First-Trimester Exposure to Fluoxetine (Prozac). JAMA 269:2246-2248.

Jacobson SJ, Jones K, Johnson K, Ceolin L, Kaur P, Sahn D, Donnenfeld AE, Rieder M, Santelli R, Smythe J, et al. 1992. “Prospective Multicentre Study of Pregnancy Outcome after Lithium Exposure during First Trimester. Lancet339:530-33.

Migraine and Migraine Medications

Shuhaiber S, Pastuszak AL, Schick B, Matsui D, Spivey G, Brochu J, Koren G. 1998. Pregnancy outcome following first trimester exposure to sumatriptan. Neurology 51:581-3.

Natural Disasters

Quinn D, Lavigne SV, Chambers C, Wolfe L, Chipman H, Cragan JD, Rasmussen SA. 2008. Addressing Concerns of Pregnant and Lactating Women After the 2005 Hurricanes: the OTIS response. American Journal of Maternal/Child Nursing, 33(4):235-41.

Other Topics

Chambers CD, Braddock SR, Briggs GG, Einarson A, Johnson YR, Miller RK, Polifka JE, Robinson LK, Stepanuk K, Lyons Jones K. 2001 Postmarketing Surveillance for Human Teratogenicity: A Model Approach. Teratology 64:252-261.

Leen-Mitchell M, Martinez L, Gallegos S, Robertson J, Carey JC. 2000. Mini-Review: History of Organized Teratology Information Services in North America. Teratology 61:314-317.