Evidence map›Paper›PMID 32268901›Full record

ArticleMalaria journal2020

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

Orvalho Augusto, Andy Stergachis, Stephanie Dellicour, Halidou Tinto, Anifa Valá, Maria Ruperez, Eusébio Macete, Seydou Nakanabo-Diallo, Adama Kazienga, Innocent Valéa and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Malaria journal, 2020. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
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

16 authors at 8 institutions in 7 countries.

Orvalho AugustoDepartment of Global Health, School of Public Health, University of Washington, Seattle, USA. orvaquim@gmail.com.
Andy StergachisDepartment of Global Health, School of Public Health, University of Washington, Seattle, USA.
Stephanie DellicourDepartment of Clinical Medicine, Liverpool School of Tropical Medicine, Liverpool, UK.
Halidou TintoInstitut de Recherche en Sciences de la Santé/URCN, Nanoro, Burkina Faso.
Anifa ValáCentro de Investigação em Saúde da Manhiça, Manhiça, Mozambique.
Maria RuperezCentro de Investigação em Saúde da Manhiça, Manhiça, Mozambique.
Eusébio MaceteCentro de Investigação em Saúde da Manhiça, Manhiça, Mozambique.
Seydou Nakanabo-DialloInstitut de Recherche en Sciences de la Santé/URCN, Nanoro, Burkina Faso.
Adama KaziengaInstitut de Recherche en Sciences de la Santé/URCN, Nanoro, Burkina Faso.
Innocent ValéaInstitut de Recherche en Sciences de la Santé/URCN, Nanoro, Burkina Faso.
Umberto d'AlessandroMedical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.
Feiko O Ter KuileDepartment of Clinical Medicine, Liverpool School of Tropical Medicine, Liverpool, UK.
Gregory S CalipDepartment of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago, Chicago, IL, USA.
Peter OumaKenya Medical Research Institute Centre for Global Health Research, Kisumu, Kenya.
Meghna DesaiCenters for Disease Control and Prevention, Atlanta, GA, USA.
Esperança SeveneFaculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique. esevene68@gmail.com.
Institut de Recherche en Sciences de la Santé · BFManhiça Health Research Centre · MZLiverpool School of Tropical Medicine · GBUniversity of Washington · USCenters for Disease Control and Prevention · USKenya Medical Research Institute · KEMRC Unit the Gambia · GMUniversity of Illinois Chicago · US

Funding

Medical Research Council MC_UP_A900_1119
6 · The paper itself

Abstract

backgroundWhile 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.

methodsData 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).

resultsOverall, 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.

conclusionACT 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.

Indexed as

Infant, Low Birth WeightInfant, Small for Gestational AgeAdultAntimalarialsArtemether, Lumefantrine Drug CombinationBurkina FasoFemaleHumansKenyaMalariaMozambiquePregnancyPregnancy Trimester, FirstPrevalenceQuinineRetrospective StudiesAntimalarialsArtemether, Lumefantrine Drug CombinationQuinineArtemisininsLow birth weightPharmacovigilanceProspective cohortSmall for gestational ageSub-Saharan Africa

Identifiers

PMID32268901
PMCPMC7140480
OpenAlexW3016105140

What OpenQuestion holds

Textmetadata
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.