Evidence map›Paper›PMID 30922317›Full record

Trial reportMalaria journal2019

Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study.

Michael Nambozi, Halidou Tinto, Victor Mwapasa, Harry Tagbor, Jean-Bertin Bukasa Kabuya, Sebastian Hachizovu, Maminata Traoré, Innocent Valea, Marc Christian Tahita, Gifty Ampofo and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00852423 (Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 4% 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.

NCT00852423 phase3completednot on this map

Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria

TypeinterventionalSponsorInstitute of Tropical Medicine, BelgiumRan2010 to 2015Enrolled3,428ConditionsMalaria in PregnancyArmsDihydroartemisinin-piperaquine, Artesunate-mefloquine, Artesunate-amodiaquine, Artemether-lumefantrine
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Placental Malaria.Current tropical medicine reports · 2020
    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

17 authors at 8 institutions in 7 countries.

Michael NamboziTropical Diseases Research Centre, Ndola, Zambia.
Halidou TintoInstitut de Recherche en Sciences de la Santé-Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro, Burkina Faso.
Victor MwapasaCollege of Medicine, Blantyre, Malawi.
Harry TagborUniversity of Health and Allied Science, Ho, Ghana.
Jean-Bertin Bukasa KabuyaTropical Diseases Research Centre, Ndola, Zambia.
Sebastian HachizovuTropical Diseases Research Centre, Ndola, Zambia.
Maminata TraoréInstitut de Recherche en Sciences de la Santé-Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro, Burkina Faso.
Innocent ValeaInstitut de Recherche en Sciences de la Santé-Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro, Burkina Faso.
Marc Christian TahitaInstitut de Recherche en Sciences de la Santé-Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro, Burkina Faso.
Gifty AmpofoUniversity of Health and Allied Science, Ho, Ghana.
Jozefien BuyzeDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Raffaella RavinettoDepartment of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Diana ArangoDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Kamala ThriemerDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Modest MulengaTropical Diseases Research Centre, Ndola, Zambia.
Jean-Pierre van GeertruydenGlobal Health Institute, University of Antwerp, Antwerp, Belgium.
Umberto D'AlessandroMedical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Gambia. udalessandro@mrc.gm.ORCID http://orcid.org/0000-0001-6341-5009
Institut de Recherche en Sciences de la Santé · BFTropical Diseases Research Centre · ZMInstituut voor Tropische Geneeskunde · BEUniversity of Health and Allied Sciences · GHBlantyre Institute for Community Ophthalmology · MWMenzies School of Health Research · AUMRC Unit the Gambia · GMUniversity of Antwerp · BE

Funding

European and Developing Countries Clinical Trials Partnership IP.2007.31080.001
6 · The paper itself

Abstract

backgroundThe World Health Organization (WHO) recommendation of treating uncomplicated malaria during the second and third trimester of pregnancy with an artemisinin-based combination therapy (ACT) has already been implemented by all sub-Saharan African countries. However, there is limited knowledge on the effect of ACT on pregnancy outcomes, and on newborn and infant's health.

methodsPregnant women with malaria in four countries (Burkina Faso, Ghana, Malawi and Zambia) were treated with either artemether-lumefantrine (AL), amodiaquine-artesunate (ASAQ), mefloquine-artesunate (MQAS), or dihydroartemisinin-piperaquine (DHA-PQ); 3127 live new-borns (822 in the AL, 775 in the ASAQ, 765 in the MQAS and 765 in the DHAPQ arms) were followed-up until their first birthday.

resultsPrevalence of placental malaria and low birth weight were 28.0% (738/2646) and 16.0% (480/2999), respectively, with no significant differences between treatment arms. No differences in congenital malformations (p = 0.35), perinatal mortality (p = 0.77), neonatal mortality (p = 0.21), and infant mortality (p = 0.96) were found.

conclusionsOutcome of pregnancy and infant survival were similar between treatment arms indicating that any of the four artemisinin-based combinations could be safely used during the second and third trimester of pregnancy without any adverse effect on the baby. Nevertheless, smaller safety differences between artemisinin-based combinations cannot be excluded; country-wide post-marketing surveillance would be very helpful to confirm such findings. Trial registration ClinicalTrials.gov, NCT00852423, Registered on 27 February 2009, https://clinicaltrials.gov/ct2/show/NCT00852423.

Indexed as

AntimalarialsArtemisininsMalariaPregnancy Complications, InfectiousAdolescentAdultAfrica South of the SaharaCohort StudiesDrug Therapy, CombinationFemaleFollow-Up StudiesHumansInfantInfant MortalityInfant, NewbornPregnancyAntimalarialsartemisininArtemisinins

Identifiers

PMID30922317
PMCPMC6437904
OpenAlexW2941340773

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.