8/5/2023 0 Comments Misshapen ribsThe Shoklo Malaria Research Unit is part of the Mahidol Oxford University Research Unit, supported by the Wellcome Trust of Great Britain. Requests for access to data should be submitted through Requests will be reviewed by a Data Access Committee to ensure that use of data is within the terms of consent and ethics approval.įunding: Part of the work presented, the ASAP studies, was supported by the Malaria in Pregnancy (MiP) Consortium, which is funded through a grant from the Bill & Melinda Gates Foundation to the Liverpool School of Tropical Medicine, United Kingdom. The work is made available under the Creative Commons CC0 public domain dedication.ĭata Availability: The complete individual patient-level data data are available through the World Wide Antimalarial Resistance Network (WWARN). This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. Received: JAccepted: MaPublished: May 2, 2017 George's, University of London, UNITED KINGDOM PLoS Med 14(5):Īcademic Editor: Sanjeev Krishna, St. (2017) First-trimester artemisinin derivatives and quinine treatments and the risk of adverse pregnancy outcomes in Africa and Asia: A meta-analysis of observational studies. In this meta-analysis of prospective observational studies, we summarize all available safety data on the effect of artemisinin exposure in the first trimester and compare the risk of miscarriage, stillbirth, and major congenital anomaly for pregnancies treated with artemisinin, quinine, or no antimalarials in the first trimester.Ĭitation: Dellicour S, Sevene E, McGready R, Tinto H, Mosha D, Manyando C, et al.Animal embryotoxicity data and the paucity of safety data in human pregnancies have prevented artemisinin derivatives from being recommended for malaria treatment in the first trimester except in life-saving circumstances, yet in malaria endemic countries, many early pregnancies are advertently or inadvertently exposed to ACTs.Artemisinin combination therapies (ACTs), the most efficacious antimalarials available, are the recommended first-line treatment for Plasmodium falciparum malaria.Malaria infection is more frequent and severe in pregnant women compared to non-pregnant women, and the adverse consequences of malaria in pregnancy require prompt, safe, and effective treatment.Key limitations of the study include the inability to control for confounding by indication in the African studies, the paucity of data on potential confounders, the limited statistical power to detect differences in congenital anomalies, and the lack of assessment of cardiovascular defects in newborns. The prevalence of major congenital anomalies was similar for first-trimester artemisinin (1.5% ) and quinine exposures (1.2% ). The corresponding risks of miscarriage, stillbirth, and pregnancy loss in a sensitivity analysis restricted to artemisinin exposures during the embryo sensitive period (6–12 wk gestation) were as follows: aHR = 1.04 (95% CI 0.54–2.01), I 2 = 0%, p = 0.910 aHR = 0.73 (95% CI 0.26–2.06), p = 0.551 and aHR = 0.98 (95% CI 0.52–2.04), p = 0.603. There was no difference in the risk of miscarriage associated with the use of artemisinins anytime during the first trimester ( n = 37/671) compared with quinine ( n = 96/945 adjusted hazard ratio = 0.73, I 2 = 0%, p = 0.228), in the risk of stillbirth (artemisinins, n = 10/654 quinine, n = 11/615 aHR = 0.29, p = 0.053), or in the risk of miscarriage and stillbirth combined (pregnancy loss) (aHR = 0.58, p = 0.099). Individual participant data (IPD) meta-analysis was used to combine the African studies, and the results were then combined with those from Thailand using aggregated data meta-analysis with a random effects model. Cox proportional hazards models, accounting for time under observation and gestational age at enrollment, were used to calculate hazard ratios. Antimalarial exposures were ascertained by self-report or active detection and confirmed by prescriptions, clinic cards, and outpatient registers. Five studies involving 30,618 pregnancies were included four from sub-Saharan Africa ( n = 6,666 pregnancies, six sites) and one from Thailand ( n = 23,952). Electronic databases including Medline, Embase, and Malaria in Pregnancy Library were searched, and investigators contacted.
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