Evidence map›Paper›PMID 32562650›Full record

Trial reportThe Lancet. Global health2020

Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis.

Michelle E Roh, Feiko O Ter Kuile, Francois Rerolle, M Maria Glymour, Stephen Shiboski, Roly Gosling, Julie Gutman, Abel Kakuru, Meghna Desai, Richard Kajubi and 4 more

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

Trial report in The Lancet. Global health, 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 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
7.0field-weighted citation impact, top 2% 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

48 citing papers in PubMed, 71 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 4 countries.

Michelle E RohDepartment of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA. Electronic address: michelle.roh@ucsf.edu.
Feiko O Ter KuileLiverpool School of Tropical Medicine, Liverpool, UK.
Francois RerolleDepartment of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.
M Maria GlymourDepartment of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.
Stephen ShiboskiDepartment of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.
Roly GoslingDepartment of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA; Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, CA, USA.
Julie GutmanMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.
Abel KakuruInfectious Diseases Research Collaboration, Kampala, Uganda.
Meghna DesaiMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA.
Richard KajubiInfectious Diseases Research Collaboration, Kampala, Uganda.
Anne L'IanzivaCenters for Disease Control and Prevention, Kisumu, Kenya.
Moses R KamyaSchool of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Grant DorseyDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, CA, USA.
R Matthew ChicoDepartment of Disease Control, Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, London, UK.
University of California, San Francisco · USInfectious Diseases Research Collaboration · UGCenters for Disease Control and Prevention · KECenters for Disease Control and Prevention · USDivision of Parasitic Diseases and Malaria · USLiverpool School of Tropical Medicine · GBLondon School of Hygiene & Tropical Medicine · GBMakerere University · UG

Funding

The immunologic consequences of prenatal exposure to malariaP01HD059454 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2008 to 2017
$22.6M
The impact of vector control interventions on adverse birth outcomes.F31HD096861 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ROH, MICHELLE · 2018 to 2020
$99k
Medical Research Council MC_PC_MR/P006914/1NICHD NIH HHS F31 HD096861NICHD NIH HHS P01 HD059454
6 · The paper itself

Abstract

backgroundTrials of intermittent preventive treatment (IPTp) of malaria in pregnant women that compared dihydroartemisinin-piperaquine with the standard of care, sulfadoxine-pyrimethamine, showed dihydroartemisinin-piperaquine was superior at preventing malaria infection, but not at improving birthweight. We aimed to assess whether sulfadoxine-pyrimethamine shows greater non-malarial benefits for birth outcomes than does dihydroartemisinin-piperaquine, and whether dihydroartemisinin-piperaquine shows greater antimalarial benefits for birth outcomes than does sulfadoxine-pyrimethamine.

methodsWe defined treatment as random assignment to sulfadoxine-pyrimethamine or dihydroartemisinin-piperaquine before pooling individual participant-level data from 1617 HIV-uninfected pregnant women in Kenya (one trial; n=806) and Uganda (two trials; n=811). We quantified the relative effect of treatment on birthweight (primary outcome) attributed to preventing placental malaria infection (mediator). We estimated antimalarial (indirect) and non-malarial (direct) effects of IPTp on birth outcomes using causal mediation analyses, accounting for confounders. We used two-stage individual participant data meta-analyses to calculate pooled-effect sizes.

findingsOverall, birthweight was higher among neonates of women randomly assigned to sulfadoxine-pyrimethamine compared with women assigned to dihydroartemisinin-piperaquine (mean difference 69 g, 95% CI 26 to 112), despite placental malaria infection being lower in the dihydroartemisinin-piperaquine group (relative risk [RR] 0·64, 95% CI 0·39 to 1·04). Mediation analyses showed sulfadoxine-pyrimethamine conferred a greater non-malarial effect than did dihydroartemisinin-piperaquine (mean difference 87 g, 95% CI 43 to 131), whereas dihydroartemisinin-piperaquine conferred a slightly larger antimalarial effect than did sulfadoxine-pyrimethamine (8 g, -9 to 26), although more frequent dosing increased the antimalarial effect (31 g, 3 to 60).

interpretationIPTp with sulfadoxine-pyrimethamine appears to have potent non-malarial effects on birthweight. Further research is needed to evaluate monthly dihydroartemisinin-piperaquine with sulfadoxine-pyrimethamine (or another compound with non-malarial effects) to achieve greater protection against malarial and non-malarial causes of low birthweight.

fundingEunice Kennedy Shriver National Institute of Child Health and Human Development, Bill & Melinda Gates Foundation, and Worldwide Antimalarial Resistance Network.

Indexed as

Birth WeightAdultAntimalarialsDrug CombinationsFemaleHumansInfant, NewbornKenyaMalariaPregnancyPregnancy Complications, ParasiticPyrimethamineSulfadoxineUgandaYoung AdultAntimalarialsDrug Combinationsfanasil, pyrimethamine drug combinationPyrimethamineSulfadoxine

Identifiers

PMID32562650
PMCPMC7303957
OpenAlexW3035820823

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.