title: Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects.
abstract: BACKGROUND
  Nausea and vomiting of pregnancy (NVP) occurs in up to 80% of pregnant women, but its association with birth outcomes is not clear. Several medications are used for the treatment of NVP; however, data are limited on their possible associations with birth defects.
  
  
  METHODS
  Using data from the National Birth Defects Prevention Study (NBDPS)-a multi-site, population-based, case-control study-we examined whether NVP or its treatment was associated with the most common noncardiac defects in the NBDPS (nonsyndromic cleft lip with or without cleft palate [CL/P], cleft palate alone [CP], neural tube defects, and hypospadias) compared with randomly selected nonmalformed live births.
  
  
  RESULTS
  Among the 4524 cases and 5859 controls included in this study, 67.1% reported first-trimester NVP, and 15.4% of them reported using at least one agent for NVP. Nausea and vomiting of pregnancy was not associated with CP or neural tube defects, but modest risk reductions were observed for CL/P (adjusted odds ratio [aOR] = 0.87; 95% confidence interval [CI], 0.77-0.98) and hypospadias (aOR = 0.84; 95% CI, 0.72-0.98). Regarding treatments for NVP in the first trimester, the following adjusted associations were observed with an increased risk: proton pump inhibitors and hypospadias (aOR = 4.36; 95% CI, 1.21-15.81), steroids and hypospadias (aOR = 2.87; 95% CI, 1.03-7.97), and ondansetron and CP (aOR = 2.37; 95% CI, 1.18-4.76), whereas antacids were associated with a reduced risk for CL/P (aOR = 0.58; 95% CI, 0.38-0.89).
  
  
  CONCLUSIONS
  NVP was not observed to be associated with an increased risk of birth defects; however, possible risks related to three treatments (i.e., proton pump inhibitors, steroids and ondansetron), which could be chance findings, warrant further investigation.
authors.affiliation: Center for Birth Defects Research and Prevention, Massachusetts Department of Public Health, Boston, Massachusetts 02108, USA. marlene.anderka@state.ma.us
authors.forename: Marlene
authors.initials: M
authors.lastname: Anderka
authors.forename: Allen A
authors.initials: AA
authors.lastname: Mitchell
authors.forename: Carol
authors.initials: C
authors.lastname: Louik
authors.forename: Martha M
authors.initials: MM
authors.lastname: Werler
authors.forename: Sonia
authors.initials: S
authors.lastname: Hernández-Diaz
authors.forename: Sonja A
authors.initials: SA
authors.lastname: Rasmussen
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology; D000328:Adult; D016022:Case-Control Studies; D002971:Cleft Lip / Q000139:chemically induced / Q000453:epidemiology; D002972:Cleft Palate / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D006801:Humans; D007021:Hypospadias / Q000139:chemically induced / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009325:Nausea / Q000188:drug therapy*; D009436:Neural Tube Defects / Q000139:chemically induced / Q000453:epidemiology; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011261:Pregnancy Trimester, First; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D013256:Steroids / Q000008:administration & dosage / Q000009:adverse effects; D014839:Vomiting / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors; D013256:Steroids; D017294:Ondansetron
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