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First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age.

Augusto, Orvalho, Stergachis, Andy, Dellicour, Stephanie, Tinto, Halidou, Valá, Anifa, Ruperez, Maria, Macete, Eusébio, Nakanabo-Diallo, Seydou, Kazienga, Adama, Valéa, Innocent, d'Alessandro, Umberto, terKuile, Feiko ORCID: https://orcid.org/0000-0003-3663-5617, Calip, Gregory S, Ouma, Peter, Desai, Meghna and Sevene, Esperança (2020) 'First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age.'. Malaria Journal, Vol 19, Issue 1, p. 144.

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Abstract

BACKGROUND
While there is increasing evidence on the safety of artemisinin-based combination therapy (ACT) for the case management of malaria in early pregnancy, little is known about the association between exposure to ACT during the first trimester and the effect on fetal growth.
METHODS
Data were analysed from prospective studies of pregnant women enrolled in Mozambique, Burkina Faso and Kenya designed to determine the association between anti-malarial drug exposure in the first trimester and pregnancy outcomes, including low birth weight (LBW) and small for gestational age (SGA). Exposure to anti-malarial drugs was ascertained retrospectively by record linkage using a combination of data collected from antenatal and adult outpatient clinic registries, prescription records and self-reported medication usage by the women. Site-level data synthesis (fixed effects and random effects) was conducted as well as individual-level analysis (fixed effects by site).
RESULTS
Overall, 1915 newborns were included with 92 and 26 exposed to ACT (artemether-lumefantrine) and quinine, respectively. In Burkina Faso, Mozambique and Kenya at recruitment, the mean age (standard deviation) was 27.1 (6.6), 24.2 (6.2) and 25.7 (6.5) years, and the mean gestational age was 24.0 (6.2), 21.2 (5.7) and 17.9 (10.2) weeks, respectively. The LBW prevalence among newborns born to women exposed to ACT and quinine (QNN) during the first trimester was 10/92 (10.9%) and 7/26 (26.9%), respectively, compared to 9.5% (171/1797) among women unexposed to any anti-malarials during pregnancy. Compared to those unexposed to anti-malarials, ACT and QNN exposed women had the pooled LBW prevalence ratio (PR) of 1.13 (95% confidence interval (CI) 0.62-2.05, p-value 0.700) and 2.03 (95% CI 1.09-3.78, p-value 0.027), respectively. Compared to those unexposed to anti-malarials ACT and QNN-exposed women had the pooled SGA PR of 0.85 (95% CI 0.50-1.44, p-value 0.543) and 1.41 (95% CI 0.71-2.77, p-value 0.322), respectively. Whereas compared to ACT-exposed, the QNN-exposed had a PR of 2.14 (95% CI 0.78-5.89, p-value 0.142) for LBW and 8.60 (95% CI 1.29-57.6, p-value 0.027) for SGA. The level of between sites heterogeneity was moderate to high.
CONCLUSION
ACT exposure during the first trimester was not associated with an increased occurrence of LBW or SGA. However, the data suggest a higher prevalence of LBW and SGA for children born to QNN-exposed pregnancies. The findings support the use of ACT (artemether-lumefantrine) for the treatment of uncomplicated malaria during the first trimester of pregnancy.

Item Type: Article
Subjects: QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 256 Antimalarials
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria
WS Pediatrics > By Age Groups > WS 410 Premature infants. Diseases of premature infants
WS Pediatrics > By Age Groups > WS 420 Newborn infants. Neonatology
WS Pediatrics > By Age Groups > WS 421 Diseases of newborn infants
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1186/s12936-020-03210-y
Depositing User: Tracy Seddon
Date Deposited: 29 Apr 2020 15:15
Last Modified: 29 Apr 2020 15:15
URI: https://archive.lstmed.ac.uk/id/eprint/14335

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