Evidence map›Paper›PMID 26581434›Full record

ArticleMalaria journal2015

Risks of miscarriage and inadvertent exposure to artemisinin derivatives in the first trimester of pregnancy: a prospective cohort study in western Kenya.

Stephanie Dellicour, Meghna Desai, George Aol, Martina Oneko, Peter Ouma, Godfrey Bigogo, Deron C Burton, Robert F Breiman, Mary J Hamel, Laurence Slutsker and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Malaria journal, 2015. 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 14 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 5 pooled it
4.6field-weighted citation impact, top 5% 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

14 citing papers in PubMed, 5 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Review
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  8. Article
  9. Review
  10. Malaria during Pregnancy.Cold Spring Harbor perspectives in medicine · 2017
    Review
  11. Review
  12. Article
  13. Observational
  14. Article
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

18 authors at 6 institutions in 3 countries.

Stephanie DellicourLiverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK. Stephanie.Dellicour@lstmed.ac.uk.
Meghna DesaiCenters for Disease Control and Prevention, Atlanta, GA, USA. mud8@cdc.gov.
George AolKenya Medical Research Institute Centre for Global Health Research, Kisumu, Kenya. gaol@kemricdc.org.
Martina OnekoKenya Medical Research Institute Centre for Global Health Research, Kisumu, Kenya. moneko@kemricdc.org.
Peter OumaKenya Medical Research Institute Centre for Global Health Research, Kisumu, Kenya. pouma@kemricdc.org.
Godfrey BigogoKenya Medical Research Institute Centre for Global Health Research, Kisumu, Kenya. gbigogo@kemricdc.org.
Deron C BurtonCenters for Disease Control and Prevention, Atlanta, GA, USA. akq7@cdc.gov.
Robert F BreimanGlobal Health Institute, Emory University, Atlanta, GA, USA. rfbreiman@emory.edu.
Mary J HamelCenters for Disease Control and Prevention, Atlanta, GA, USA. mlh8@cdc.gov.
Laurence SlutskerCenters for Disease Control and Prevention, Atlanta, GA, USA. lms5@cdc.gov.
Daniel FeikinCenters for Disease Control and Prevention, Atlanta, GA, USA. drf0@cdc.gov.
Simon KariukiKenya Medical Research Institute Centre for Global Health Research, Kisumu, Kenya. skariuki@kemricdc.org.
Frank OdhiamboKenya Medical Research Institute Centre for Global Health Research, Kisumu, Kenya. fodhiambo@kemricdc.org.
Jayesh PanditBayer Healthcare, Nairobi, Kenya. jayesh_pandit@hotmail.com.
Kayla F LasersonCenters for Disease Control and Prevention, Atlanta, GA, USA. kel4@cdc.gov.
Greg CalipPharmacy Systems, Outcomes and Policy Department, University of Illinois at Chicago, Chicago, USA. gcalip@fredhutch.org.
Andy StergachisDepartments of Pharmacy and Global Health, Schools of Pharmacy and Public Health, University of Washington, Seattle, USA. stergach@uw.edu.
Feiko O ter KuileLiverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK. Feiko.TerKuile@lstmed.ac.uk.
Centers for Disease Control and Prevention · USKenya Medical Research Institute · KELiverpool School of Tropical Medicine · GBEmory University · USSeattle University · USUniversity of Illinois Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe artemisinin anti-malarials are widely deployed as artemisinin-based combination therapy (ACT). However, they are not recommended for uncomplicated malaria during the first trimester because safety data from humans are scarce.

methodsThis was a prospective cohort study of women of child-bearing age carried out in 2011-2013, evaluating the relationship between inadvertent ACT exposure during first trimester and miscarriage. Community-based surveillance was used to identify 1134 early pregnancies. Cox proportional hazard models with left truncation were used.

resultsThe risk of miscarriage among pregnancies exposed to ACT (confirmed + unconfirmed) in the first trimester, or during the embryo-sensitive period (≥6 to <13 weeks gestation) was higher than among pregnancies unexposed to anti-malarials in the first trimester: hazard ratio (HR) = 1.70, 95 % CI (1.08-2.68) and HR = 1.61 (0.96-2.70). For confirmed ACT-exposures (primary analysis) the corresponding values were: HR = 1.24 (0.56-2.74) and HR = 0.73 (0.19-2.82) relative to unexposed women, and HR = 0.99 (0.12-8.33) and HR = 0.32 (0.03-3.61) relative to quinine exposure, but the numbers of quinine exposures were very small.

conclusionACT exposure in early pregnancy was more common than quinine exposure. Confirmed inadvertent artemisinin exposure during the potential embryo-sensitive period was not associated with increased risk of miscarriage. Confirmatory studies are needed to rule out a smaller than three-fold increase in risk.

Indexed as

Pregnancy Trimester, FirstAbortion, SpontaneousAdolescentAdultAntimalarialsArtemisininsFemaleHumansKenyaMiddle AgedPregnancyProspective StudiesRisk AssessmentYoung AdultAntimalarialsartemisininArtemisinins

Identifiers

PMID26581434
PMCPMC4652370
OpenAlexW2174246153

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.