Evidence map›Paper›PMID 32772921›Full record

Trial reportBMC medicine2020

Impact of intermittent preventive treatment of malaria in pregnancy with dihydroartemisinin-piperaquine versus sulfadoxine-pyrimethamine on the incidence of malaria in infancy: a randomized controlled trial.

Abel Kakuru, Prasanna Jagannathan, Richard Kajubi, Teddy Ochieng, Harriet Ochokoru, Miriam Nakalembe, Tamara D Clark, Theodore Ruel, Sarah G Staedke, Daniel Chandramohan and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02793622 (Prevention of Malaria in HIV-uninfected Pregnant Women and Infants), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 6% 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.

NCT02793622 phase3completednot on this map

Prevention of Malaria in HIV-uninfected Pregnant Women and Infants

TypeinterventionalSponsorUniversity of California, San FranciscoRan2016 to 2018Enrolled782ConditionsMalariaArmsMonthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy, Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Review
  11. Sex-Linked Differences in Malaria Risk Across the Lifespan.Current topics in microbiology and immunology · 2023
    Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Age-Related Changes in Malaria Clinical Phenotypes During Infancy Are Modified by Sickle Cell Trait.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  17. 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

13 authors at 6 institutions in 3 countries.

Abel KakuruLondon School of Hygiene and Tropical Medicine, London, UK. akakuru@idrc-uganda.org.ORCID 0000-0001-9941-1309
Prasanna JagannathanDepartment of Medicine, Stanford University, Stanford, USA.
Richard KajubiInfectious Diseases Research Collaboration, Kampala, Uganda.
Teddy OchiengInfectious Diseases Research Collaboration, Kampala, Uganda.
Harriet OchokoruInfectious Diseases Research Collaboration, Kampala, Uganda.
Miriam NakalembeDepartment of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Kampala, Uganda.
Tamara D ClarkDepartment of Medicine, University of California, San Francisco, USA.
Theodore RuelDepartment of Paediatrics, University of California, San Francisco, USA.
Sarah G StaedkeLondon School of Hygiene and Tropical Medicine, London, UK.
Daniel ChandramohanLondon School of Hygiene and Tropical Medicine, London, UK.
Diane V HavlirDepartment of Medicine, University of California, San Francisco, USA.
Moses R KamyaSchool of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Grant DorseyDepartment of Medicine, University of California, San Francisco, USA.
University of California, San Francisco · USInfectious Diseases Research Collaboration · UGLondon School of Hygiene & Tropical Medicine · GBMakerere University · UGStanford University · USUniversity of London · GB

Funding

The immunologic consequences of prenatal exposure to malariaP01HD059454 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2008 to 2017
$22.6M
Bill and Melinda Gates Foundation OPP1141549NICHD NIH HHS P01 HD059454
6 · The paper itself

Abstract

backgroundIntermittent preventive treatment of malaria during pregnancy (IPTp) with dihydroartemisinin-piperaquine (DP) significantly reduces the burden of malaria during pregnancy compared to sulfadoxine-pyrimethamine (SP), the current standard of care, but its impact on the incidence of malaria during infancy is unknown.

methodsWe conducted a double-blind randomized trial to compare the incidence of malaria during infancy among infants born to HIV-uninfected pregnant women who were randomized to monthly IPTp with either DP or SP. Infants were followed for all their medical care in a dedicated study clinic, and routine assessments were conducted every 4 weeks. At all visits, infants with fever and a positive thick blood smear were diagnosed and treated for malaria. The primary outcome was malaria incidence during the first 12 months of life. All analyses were done by modified intention to treat.

resultsOf the 782 women enrolled, 687 were followed through delivery from December 9, 2016, to December 5, 2017, resulting in 678 live births: 339 born to mothers randomized to SP and 339 born to those randomized to DP. Of these, 581 infants (85.7%) were followed up to 12 months of age. Overall, the incidence of malaria was lower among infants born to mothers randomized to DP compared to SP, but the difference was not statistically significant (1.71 vs 1.98 episodes per person-year, incidence rate ratio (IRR) 0.87, 95% confidence interval (CI) 0.73-1.03, p = 0.11). Stratifying by infant sex, IPTp with DP was associated with a lower incidence of malaria among male infants (IRR 0.75, 95% CI 0.58-0.98, p = 0.03) but not female infants (IRR 0.99, 95% CI 0.79-1.24, p = 0.93).

conclusionDespite the superiority of DP for IPTp, there was no evidence of a difference in malaria incidence during infancy in infants born to mothers who received DP compared to those born to mothers who received SP. Only male infants appeared to benefit from IPTp-DP suggesting that IPTp-DP may provide additional benefits beyond birth. Further research is needed to further explore the benefits of DP versus SP for IPTp on the health outcomes of infants.

trial registrationClinicalTrials.gov, NCT02793622 . Registered on June 8, 2016.

Indexed as

AdultAntimalarialsArtesunateDouble-Blind MethodDrug CombinationsFemaleHumansIncidenceInfantInfant, NewbornMalariaMalePregnancyPregnancy Complications, ParasiticPyrimethamineSulfadoxineAntimalarialsArtesunateDrug Combinationsfanasil, pyrimethamine drug combinationPyrimethamineSulfadoxineDihydroartemisinin-piperaquineInfantsIntermittent preventive treatmentMalariaPregnancySulfadoxine-pyrimethamine

Identifiers

PMID32772921
PMCPMC7416391
OpenAlexW3047789633

What OpenQuestion holds

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LicenceCC BY
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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.