Evidence map›Paper›PMID 24884890›Full record

Observational studyMalaria journal2014

Safety of artemether-lumefantrine exposure in first trimester of pregnancy: an observational cohort.

Dominic Mosha, Festo Mazuguni, Sigilbert Mrema, Esperanca Sevene, Salim Abdulla, Blaise Genton

Registry-linked trialOpen access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Malaria journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05757167 (Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
6.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05757167 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity

TypeinterventionalSponsorDuke UniversityRan2023 to 2026Enrolled2,174ConditionsMalaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, PregnancyArmsMalaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 3 countries.

Dominic MoshaIfakara Health Institute, Rufiji HDSS, P,O Box 40, Rufiji, Tanzania. dfmosha@hotmail.com.
Festo Mazuguni
Sigilbert Mrema
Esperanca Sevene
Salim Abdulla
Blaise Genton
Ifakara Health Institute · TZEduardo Mondlane University · MZUniversity of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Pregnancy OutcomePregnancy Trimester, FirstAdolescentAdultAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsCohort StudiesDrug CombinationsEthanolaminesFemaleFluorenesHumansInfant, NewbornMalariaMiddle AgedAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenesQuinine

Identifiers

PMID24884890
PMCPMC4040412
OpenAlexW2161216154

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.