期刊
MALARIA JOURNAL
卷 14, 期 -, 页码 -出版社
BMC
DOI: 10.1186/s12936-015-0950-6
关键词
Anti-malarials; Pharmacovigilance; Drug safety in pregnancy; Teratogenicity; Miscarriage
资金
- Lwak Mission Hospital Board
- Malaria in Pregnancy (MiP) Consortium - Bill and Melinda Gates Foundation
- US Centers for Disease Control and Prevention (CDC), Division of Parasitic Diseases and Malaria
- Kenya Medical Research Institute (KEMRI), Center for Global Health Research (CGHR), Kisumu, Kenya
- Asembo District health and medical team
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.
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