Abstract
BackgroundThe 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.MethodsThis 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.ResultsThe 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.ConclusionACT 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 materialThe online version of this article (doi:10.1186/s12936-015-0950-6) contains supplementary material, which is available to authorized users.
Highlights
The artemisinin anti-malarials are widely deployed as artemisinin-based combination therapy (ACT)
As women may not be aware of their pregnancy or do not declare an early pregnancy, and because clinic staff do not often assess for pregnancy in women of child-bearing age (WOCBA), the risk of exposure to drugs not recommended in pregnancy, including to potential teratogens, is possible during this period [18]
Overview of study design This was a prospective cohort study conducted among WOCBA (15–49 years of age) residing in a highly malarious area in western Kenya with a population under continuous health and demographic surveillance system (HDSS) monitoring as part of the collaboration between the Kenya Medical Research Institute (KEMRI) and Centers for Disease Control and Prevention (CDC) [21]
Summary
The artemisinin anti-malarials are widely deployed as artemisinin-based combination therapy (ACT) They are not recommended for uncomplicated malaria during the first trimester because safety data from humans are scarce. Artemisinin-based combination therapy (ACT) antimalarials have been adopted as first‐line treatment for falciparum malaria in almost all endemic countries, providing life‐saving benefits to children, adults and pregnant women globally [1]. Their safety is uncertain when used in early pregnancy. There are limited data available to assess whether ACT is embryo-toxic or teratogenic in humans; fewer than 700 exposures in the first trimester have been well documented [9,10,11,12,13,14,15]. As ACT is increasingly available, a growing number of women will be inadvertently exposed to an artemisinin compound in early pregnancy, including during the period when foetal organs and tissues are formed
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