Risks of miscarriage and inadvertent exposure to artemisinin derivatives in the first trimester of pregnancy: a prospective cohort study in western Kenya

Details

• Alternative Title:
  Malar J
• Personal Author:
  Dellicour, Stephanie ; Desai, Meghna ; Aol, George ; Oneko, Martina ; Ouma, Peter ; Bigogo, Godfrey ; Burton, Deron C. ; Breiman, Robert F. ; Hamel, Mary J. ; Slutsker, Laurence ; Feikin, Daniel ; Kariuki, Simon ; Odhiambo, Frank ; Pandit, Jayesh ; Laserson, Kayla F. ; Calip, Greg ; Stergachis, Andy ; ter Kuile, Feiko O.
  More +
• Description:
  Background ; The artemisinin anti-malarials are widely deployed as artemisinin-based combination therapy (ACT). However, they are not recommended for uncomplicated malaria during the first trimester because safety data from humans are scarce. ; Methods ; This was a prospective cohort study of women of child-bearing age carried out in 2011–2013, evaluating the relationship between inadvertent ACT exposure during first trimester and miscarriage. Community-based surveillance was used to identify 1134 early pregnancies. Cox proportional hazard models with left truncation were used. ; Results ; The risk of miscarriage among pregnancies exposed to ACT (confirmed + unconfirmed) in the first trimester, or during the embryo-sensitive period (≥6 to <13 weeks gestation) was higher than among pregnancies unexposed to anti-malarials in the first trimester: hazard ratio (HR) = 1.70, 95 % CI (1.08–2.68) and HR = 1.61 (0.96–2.70). For confirmed ACT-exposures (primary analysis) the corresponding values were: HR = 1.24 (0.56–2.74) and HR = 0.73 (0.19–2.82) relative to unexposed women, and HR = 0.99 (0.12–8.33) and HR = 0.32 (0.03–3.61) relative to quinine exposure, but the numbers of quinine exposures were very small. ; Conclusion ; ACT exposure in early pregnancy was more common than quinine exposure. Confirmed inadvertent artemisinin exposure during the potential embryo-sensitive period was not associated with increased risk of miscarriage. Confirmatory studies are needed to rule out a smaller than three-fold increase in risk. ; Electronic supplementary material ; The online version of this article (doi:10.1186/s12936-015-0950-6) contains supplementary material, which is available to authorized users.
• Subjects:
  • Research
  • Anti-malarials
  • Pharmacovigilance
  • Drug safety in pregnancy
  • Teratogenicity
  • Miscarriage
• Source:
  Malar J. 14.
• Pubmed ID:
  26581434
• Pubmed Central ID:
  PMC4652370
• Document Type:
  Journal Article
• Place as Subject:
  Kenya
• Volume:
  14
• Download URL:
  https://stacks.cdc.gov/view/cdc/35769/cdc_35769_DS1.pdf
• File Type:
  [PDF - 1.00 MB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:c45b14108a1138c02911335cea17684faf14a6ed633f07e938eabaac28320cab