DSpace Repository
Safety of artemether-lumefantrine exposure in first trimester of pregnancy: an observational cohort
JavaScript is disabled for your browser. Some features of this site may not work without it.
| dc.contributor.author | Mosha, Dominic | |
| dc.contributor.author | Mazuguni, Festo | |
| dc.contributor.author | Mrema, Sigilbert | |
| dc.contributor.author | Sevene, Esperanca | |
| dc.contributor.author | Abdulla, Salim | |
| dc.contributor.author | Genton, Blaise | |
| dc.date.accessioned | 2024-04-16T12:41:21Z | |
| dc.date.available | 2024-04-16T12:41:21Z | |
| dc.date.issued | 2014 | |
| dc.identifier.uri | http://www.repositorio.uem.mz/handle258/911 | |
| dc.description.abstract | Background: There is limited data available regarding safety profile of artemisinins in early pregnancy. They are, therefore, not recommended by WHO as a first-line treatment for malaria in first trimester due to associated embryo-foetal toxicity in animal studies. The study assessed birth outcome among pregnant women inadvertently exposed to artemether-lumefantrine (AL) during first trimester in comparison to those of women exposed to other anti-malarial drugs or no drug at all during the same period of pregnancy. Methods: Pregnant women with gestational age <20 weeks were recruited from Maternal Health clinics or from monthly house visits (demographic surveillance), and followed prospectively until delivery. Results: 2167 pregnant women were recruited and 1783 (82.3%) completed the study until delivery. 319 (17.9%) used anti-malarials in first trimester, of whom 172 (53.9%) used (AL), 78 (24.4%) quinine, 66 (20.7%) sulphadoxine-pyrimethamine (SP) and 11 (3.4%) amodiaquine. Quinine exposure in first trimester was associated with an increased risk of miscarriage/stillbirth (OR 2.5; 1.3–5.1) and premature birth (OR 2.6; 1.3–5.3) as opposed to AL with (OR 1.4; 0.8–2.5) for miscarriage/stillbirth and (OR 0.9; 0.5–1.8) for preterm birth. Congenital anomalies were identified in 4 exposure groups namely AL only (1/164[0.6%]), quinine only (1/70[1.4%]), SP (2/66[3.0%]), and non-anti-malarial exposure group (19/1464[1.3%]). Conclusion: Exposure to AL in first trimester was more common than to any other anti-malarial drugs. Quinine exposure was associated with adverse pregnancy outcomes which was not the case following other anti-malarial intake. Since AL and quinine were used according to their availability rather than to disease severity, it is likely that the effect observed was related to the drug and not to the disease itself. Even with this caveat, a change of policy from quinine to AL for the treatment of uncomplicated malaria during the whole pregnancy period could be already envisaged. | en_US |
| dc.description.sponsorship | Existem dados limitados disponíveis sobre o perfil de segurança das artemisininas no início da gravidez. Eles são, portanto, não é recomendado pela OMS como tratamento de primeira linha para a malária no primeiro trimestre devido a toxicidade embriofetal em estudos com animais. O estudo avaliou o resultado do nascimento entre mulheres grávidas inadvertidamente expostas ao arteméter-lumefantrina (AL) durante o primeiro trimestre em comparação com as mulheres expostas a outros medicamentos antimaláricos ou nenhum medicamento durante o mesmo período da gravidez. Métodos: Gestantes com idade gestacional <20 semanas foram recrutadas em clínicas de Saúde Materna ou em visitas domiciliares mensais (vigilância demográfica) e acompanhadas prospectivamente até o parto. Resultados: Foram recrutadas 2.167 gestantes e 1.783 (82,3%) completaram o estudo até o parto. 319 (17,9%) usaram antimaláricos no primeiro trimestre, dos quais 172 (53,9%) usaram (AL), 78 (24,4%) quinino, 66 (20,7%) sulfadoxina-pirimetamina (SP) e 11 (3,4%) amodiaquina. A exposição ao quinino no primeiro trimestre foi associada com um risco aumentado de aborto espontâneo/natimorto (OR 2,5; 1,3–5,1) e parto prematuro (OR 2,6; 1,3–5,3) em oposição para AL com (OR 1,4; 0,8–2,5) para aborto espontâneo/natimorto e (OR 0,9; 0,5–1,8) para parto prematuro. Anomalias congênitas foram identificados em 4 grupos de exposição, nomeadamente AL apenas (1/164 [0,6%]), apenas quinino (1/70 [1,4%]), SP (2/66 [3,0%]) e grupo de exposição não antimalárica (19/1464[1,3%]). Conclusão: A exposição ao AL no primeiro trimestre foi mais comum do que a qualquer outro medicamento antimalárico. Quinina exposição foi associada a resultados adversos na gravidez, o que não aconteceu após outros medicamentos antimaláricos. ingestão. Como o AL e o quinino foram utilizados de acordo com a sua disponibilidade e não de acordo com a gravidade da doença, é provável que que o efeito observado estava relacionado ao medicamento e não à doença em si. Mesmo com esta ressalva, uma mudança de política do quinino ao AL para o tratamento da malária não complicada durante todo o período da gravidez poderia já estar previsto. | en_US |
| dc.language.iso | eng | en_US |
| dc.publisher | BioMed Central | en_US |
| dc.rights | openAcess | en_US |
| dc.subject | Pregnancy | en_US |
| dc.subject | Safety | en_US |
| dc.subject | Artemether-lumefantrine | en_US |
| dc.subject | Exposure | en_US |
| dc.title | Safety of artemether-lumefantrine exposure in first trimester of pregnancy: an observational cohort | en_US |
| dc.type | article | en_US |
| dc.description.resumo | Background: There is limited data available regarding safety profile of artemisinins in early pregnancy. They are, therefore, not recommended by WHO as a first-line treatment for malaria in first trimester due to associated embryo-foetal toxicity in animal studies. The study assessed birth outcome among pregnant women inadvertently exposed to artemether-lumefantrine (AL) during first trimester in comparison to those of women exposed to other anti-malarial drugs or no drug at all during the same period of pregnancy. Methods: Pregnant women with gestational age <20 weeks were recruited from Maternal Health clinics or from monthly house visits (demographic surveillance), and followed prospectively until delivery. Results: 2167 pregnant women were recruited and 1783 (82.3%) completed the study until delivery. 319 (17.9%) used anti-malarials in first trimester, of whom 172 (53.9%) used (AL), 78 (24.4%) quinine, 66 (20.7%) sulphadoxine-pyrimethamine (SP) and 11 (3.4%) amodiaquine. Quinine exposure in first trimester was associated with an increased risk of miscarriage/stillbirth (OR 2.5; 1.3–5.1) and premature birth (OR 2.6; 1.3–5.3) as opposed to AL with (OR 1.4; 0.8–2.5) for miscarriage/stillbirth and (OR 0.9; 0.5–1.8) for preterm birth. Congenital anomalies were identified in 4 exposure groups namely AL only (1/164[0.6%]), quinine only (1/70[1.4%]), SP (2/66[3.0%]), and non-anti-malarial exposure group (19/1464[1.3%]). Conclusion: Exposure to AL in first trimester was more common than to any other anti-malarial drugs. Quinine exposure was associated with adverse pregnancy outcomes which was not the case following other anti-malarial intake. Since AL and quinine were used according to their availability rather than to disease severity, it is likely that the effect observed was related to the drug and not to the disease itself. Even with this caveat, a change of policy from quinine to AL for the treatment of uncomplicated malaria during the whole pregnancy period could be already envisaged. Keywords: Pregnancy, Safety, Artemether-lumefantrine, Exposure | en_US |
| dc.journal | Malaria Journal | en_US |
