@article{043d41b1c32548a0831a1ee2f687665b,
title = "Risks of miscarriage and inadvertent exposure to artemisinin derivatives in the first trimester of pregnancy: A prospective cohort study in western Kenya",
abstract = "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.",
keywords = "Anti-malarials, Drug safety in pregnancy, Miscarriage, Pharmacovigilance, Teratogenicity",
author = "Stephanie Dellicour and Meghna Desai and George Aol and Martina Oneko and Peter Ouma and Godfrey Bigogo and Burton, {Deron C.} and Breiman, {Robert F.} and Hamel, {Mary J.} and Laurence Slutsker and Daniel Feikin and Simon Kariuki and Frank Odhiambo and Jayesh Pandit and Laserson, {Kayla F.} and Greg Calip and Andy Stergachis and {Ter Kuile}, {Feiko O.}",
note = "Funding Information: The work presented in this paper was performed under the KEMRI and CDC Collaboration in western Kenya. We are very grateful to all participants for taking part in the study. We wish to thank the EMEP study team for their perseverance and hard work. We are grateful to the International Emerging Infection Program (IEIP) team for their help and collaboration. Furthermore we thank the Asembo District health and medical team and the Lwak Mission Hospital Board for their support. We also thank John Williamson and Jane Bruce for the statistical support and advice. KEMRI/CDC HDSS is a member of the INDEPTH Network. The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the US Centers for Disease Control and Prevention. This paper is published with the permission of KEMRI Director. This work was partly supported by the Malaria in Pregnancy (MiP) Consortium, which is funded through a grant from the Bill and Melinda Gates Foundation to the Liverpool School of Tropical Medicine, UK and partly by the US Centers for Disease Control and Prevention (CDC), Division of Parasitic Diseases and Malaria through a cooperative agreement with Kenya Medical Research Institute (KEMRI), Center for Global Health Research (CGHR), Kisumu, Kenya. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: {\textcopyright} 2015 Dellicour et al.",
year = "2015",
month = nov,
day = "18",
doi = "10.1186/s12936-015-0950-6",
language = "English (US)",
volume = "14",
journal = "Malaria journal",
issn = "1475-2875",
publisher = "BioMed Central",
number = "1",
}