Abstract
BackgroundThere 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.MethodsPregnant women with gestational age <20 weeks were recruited from Maternal Health clinics or from monthly house visits (demographic surveillance), and followed prospectively until delivery.Results2167 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%]).ConclusionExposure 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.
Highlights
There is limited data available regarding safety profile of artemisinins in early pregnancy
The present study aims at assessing the maternal and birth outcomes in pregnant women who were inadvertently exposed to 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 using two Health Demographic Surveillance System (HDSS) platforms in Tanzania
Pregnancy outcome and anti-malarial exposure Among 1783 deliveries, there were 5 maternal deaths that occurred within 24 hours, three were due to postpartum haemorrhage and the remaining two each was secondary to eclampsia and disseminated intravascular coagulopathy (DIC), respectively
Summary
There is limited data available regarding safety profile of artemisinins in early pregnancy. They are, not recommended by WHO as a first-line treatment for malaria in first trimester due to associated embryo-foetal toxicity in animal studies. Safety concerns of artemisinins in first trimester are the associated risks of visceral and skeletal anomalies following animal studies in early stage of pregnancy [6,7]. Two previous small-scale studies assessing Zambian and Sudanese pregnant women exposed to artemisinin during first trimester could not find any association between drug exposure and maternal or birth adverse outcomes [8,9]. Evidence is still scarce to ensure safety of ACT during first trimester
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