title: Pregnancy outcome following in utero exposure to hydroxychloroquine: a prospective comparative observational study.
abstract: OBJECTIVE
  To evaluate pregnancy safety of hydroxychloroquine (HCQ) for rheumatologic diseases.
  
  
  METHODS
  Prospective comparative observational study done at the Israeli teratology information service between 1998 and 2006.
  
  
  RESULTS
  114 HCQ-exposed pregnancies (98.2% in the first trimester, T1) were followed-up and compared with 455 pregnancies of women counseled for non-teratogenic exposure. The difference in the rate of congenital anomalies was not statistically significant [7/97 (7.2%) vs. 15/440 (3.4%), p=0.094]. The analysis was repeated among those exposed in T1 excluding genetic or cytogenetic anomalies or congenital infections [5/95 (5.3%) vs. 14/440 (3.2%), p=0.355]. There were no cases of neonatal lupus erythematosus. The gestational age at delivery was earlier, rate of preterm delivery higher, and birth weight lower, in the HCQ group.
  
  
  CONCLUSIONS
  The present study suggests that HCQ treatment in pregnancy is not a major human teratogen. The earlier gestational age and lower birth weight might be associated with maternal disease.
authors.affiliation: The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel. orna.diav-citrin@moh.health.gov.il
authors.forename: Orna
authors.initials: O
authors.lastname: Diav-Citrin
authors.forename: Shani
authors.initials: S
authors.lastname: Blyakhman
authors.forename: Svetlana
authors.initials: S
authors.lastname: Shechtman
authors.forename: Asher
authors.initials: A
authors.lastname: Ornoy
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001724:Birth Weight; D003424:Crohn Disease / Q000188:drug therapy; D005260:Female; D005865:Gestational Age; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D007231:Infant, Newborn; D007557:Israel / Q000453:epidemiology; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008297:Male; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D011446:Prospective Studies
chemical_list: D018501:Antirheumatic Agents; D006886:Hydroxychloroquine