First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age
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...
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2020-04-01
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Series: | Malaria Journal |
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Online Access: | http://link.springer.com/article/10.1186/s12936-020-03210-y |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Orvalho Augusto Andy Stergachis Stephanie Dellicour Halidou Tinto Anifa Valá Maria Ruperez Eusébio Macete Seydou Nakanabo-Diallo Adama Kazienga Innocent Valéa Umberto d’Alessandro Feiko O. ter Kuile Gregory S. Calip Peter Ouma Meghna Desai Esperança Sevene |
spellingShingle |
Orvalho Augusto Andy Stergachis Stephanie Dellicour Halidou Tinto Anifa Valá Maria Ruperez Eusébio Macete Seydou Nakanabo-Diallo Adama Kazienga Innocent Valéa Umberto d’Alessandro Feiko O. ter Kuile Gregory S. Calip Peter Ouma Meghna Desai Esperança Sevene First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age Malaria Journal Low birth weight Small for gestational age Prospective cohort Artemisinins Sub-Saharan Africa Pharmacovigilance |
author_facet |
Orvalho Augusto Andy Stergachis Stephanie Dellicour Halidou Tinto Anifa Valá Maria Ruperez Eusébio Macete Seydou Nakanabo-Diallo Adama Kazienga Innocent Valéa Umberto d’Alessandro Feiko O. ter Kuile Gregory S. Calip Peter Ouma Meghna Desai Esperança Sevene |
author_sort |
Orvalho Augusto |
title |
First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age |
title_short |
First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age |
title_full |
First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age |
title_fullStr |
First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age |
title_full_unstemmed |
First trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age |
title_sort |
first trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational age |
publisher |
BMC |
series |
Malaria Journal |
issn |
1475-2875 |
publishDate |
2020-04-01 |
description |
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. |
topic |
Low birth weight Small for gestational age Prospective cohort Artemisinins Sub-Saharan Africa Pharmacovigilance |
url |
http://link.springer.com/article/10.1186/s12936-020-03210-y |
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doaj-debc9c18a62146db8a7e9dedab4e13ba2020-11-25T02:06:33ZengBMCMalaria Journal1475-28752020-04-0119111510.1186/s12936-020-03210-yFirst trimester use of artemisinin-based combination therapy and the risk of low birth weight and small for gestational ageOrvalho Augusto0Andy Stergachis1Stephanie Dellicour2Halidou Tinto3Anifa Valá4Maria Ruperez5Eusébio Macete6Seydou Nakanabo-Diallo7Adama Kazienga8Innocent Valéa9Umberto d’Alessandro10Feiko O. ter Kuile11Gregory S. Calip12Peter Ouma13Meghna Desai14Esperança Sevene15Department of Global Health, School of Public Health, University of WashingtonDepartment of Global Health, School of Public Health, University of WashingtonDepartment of Clinical Medicine, Liverpool School of Tropical MedicineInstitut de Recherche en Sciences de la Santé/URCNCentro de Investigação em Saúde da ManhiçaCentro de Investigação em Saúde da ManhiçaCentro de Investigação em Saúde da ManhiçaInstitut de Recherche en Sciences de la Santé/URCNInstitut de Recherche en Sciences de la Santé/URCNInstitut de Recherche en Sciences de la Santé/URCNMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical MedicineDepartment of Clinical Medicine, Liverpool School of Tropical MedicineDepartment of Pharmacy Systems, Outcomes and Policy, University of Illinois at ChicagoKenya Medical Research Institute Centre for Global Health ResearchCenters for Disease Control and PreventionFaculty of Medicine, Eduardo Mondlane UniversityAbstract 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.http://link.springer.com/article/10.1186/s12936-020-03210-yLow birth weightSmall for gestational ageProspective cohortArtemisininsSub-Saharan AfricaPharmacovigilance |