Evidence map›Paper›PMID 22554092›Full record

Trial reportMalaria journal2012

Artemether-lumefantrine to treat malaria in pregnancy is associated with reduced placental haemozoin deposition compared to quinine in a randomized controlled trial.

Atis Muehlenbachs, Carolyn Nabasumba, Rose McGready, Eleanor Turyakira, Benon Tumwebaze, Mehul Dhorda, Dan Nyehangane, Aisha Nalusaji, Franois Nosten, Philippe J Guerin and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00495508 (A Randomised, Open-label Non-inferiority Trial of Artemether-lumefantrine Versus Quinine for the Treatment of Uncomplicated Falciparum Malaria During Pregnancy, Mbarara, Uganda), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT00495508 phase4completednot on this map

A Randomised, Open-label Non-inferiority Trial of Artemether-lumefantrine Versus Quinine for the Treatment of Uncomplicated Falciparum Malaria During Pregnancy, Mbarara, Uganda (2006-2007)

TypeinterventionalSponsorEpicentreRan2006 to 2009Enrolled300ConditionsMalariaArmsQuinine, artemether / lumefantrine
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Review
  10. Observational
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Diagnosing malaria in pregnancy: an update.Expert review of anti-infective therapy · 2012
    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

11 authors at 5 institutions in 4 countries.

Atis MuehlenbachsDepartment of Pathology, University of Washington, Box 357470, 1959 NE Pacific Street, Seattle, WA, USA. amuehlen@u.washington.edu
Carolyn Nabasumba
Rose McGready
Eleanor Turyakira
Benon Tumwebaze
Mehul Dhorda
Dan Nyehangane
Aisha Nalusaji
Franois Nosten
Philippe J Guerin
Patrice Piola
Epicentre Uganda · UGMahidol Oxford Tropical Medicine Research Unit · THMahidol University · THSeattle University · USUniversity of Oxford · GB

Funding

Wellcome Trust 089275
6 · The paper itself

Abstract

backgroundData on efficacy of artemisinin-based combination therapy (ACT) to treat Plasmodium falciparum during pregnancy in sub-Saharan Africa is scarce. A recent open label, randomized controlled trial in Mbarara, Uganda demonstrated that artemether-lumefantrine (AL) is not inferior to quinine to treat uncomplicated malaria in pregnancy. Haemozoin can persist in the placenta following clearance of parasites, however there is no data whether ACT can influence the amount of haemozoin or the dynamics of haemozoin clearance.

methodsWomen attending antenatal clinics with weekly screening and positive blood smears by microscopy were eligible to participate in the trial and were followed to delivery. Placental haemozoin deposition and inflammation were assessed by histology. To determine whether AL was associated with increased haemozoin clearance, population haemozoin clearance curves were calculated based on the longitudinal data.

resultsOf 152 women enrolled in each arm, there were 97 and 98 placental biopsies obtained in the AL and quinine arms, respectively. AL was associated with decreased rates of moderate to high grade haemozoin deposition (13.3% versus 25.8%), which remained significant after correcting for gravidity, time of infection, re-infection, and parasitaemia. The amount of haemozoin proportionately decreased with the duration of time between treatment and delivery and this decline was greater in the AL arm. Haemozoin was not detected in one third of biopsies and the prevalence of inflammation was low, reflecting the efficacy of antenatal care with early detection and prompt treatment of malaria.

conclusionsPlacental haemozoin deposition was decreased in the AL arm demonstrating a relationship between pharmacological properties of drug to treat antenatal malaria and placental pathology at delivery. Histology may be considered an informative outcome for clinical trials to evaluate malaria control in pregnancy.

trial registrationREGISTRY: http://clinicaltrials.gov/ct2/show/NCT00495508.

Indexed as

AdultAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFemaleFluorenesHemeproteinsHistocytochemistryHumansInfant, NewbornMalaria, FalciparumPlacentaPregnancyPregnancy Complications, InfectiousAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenesHemeproteinshemozoinQuinine

Identifiers

PMID22554092
PMCPMC3487992
OpenAlexW2157847822

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.