Evidence map›Paper›PMID 38343768›Full record

ArticleGates open research2023

Protocol and statistical analysis plan for a randomized controlled trial of the effect of intravenous iron on anemia in Malawian pregnant women in their third trimester (REVAMP - TT).

Rebecca Harding, Ernest Moya, Ricardo Ataíde, Zinenani Truwah, Glory Mzembe, Gomezgani Mhango, Ayşe V Demir, William Stones, Louise Randall, Marc Seal and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Gates open research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. 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

16 authors at 8 institutions in 6 countries.

Rebecca HardingPopulation Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.ORCID 0000-0003-4267-716X
Ernest MoyaTraining and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.
Ricardo AtaídePopulation Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.ORCID 0000-0002-1014-0432
Zinenani TruwahTraining and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.ORCID 0000-0001-5952-7155
Glory MzembeTraining and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.ORCID 0000-0002-7277-9987
Gomezgani MhangoTraining and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.
Ayşe V DemirMeander Medical Center, Laboratory for Clinical Chemistry, Maatweg 3, Amersfoort, 3813 TZ, The Netherlands.
William StonesCentre for Reproductive Health, Kamuzu University of Health Sciences, Private Bag 360, Chichiri, Blantyre, BT3, Malawi.ORCID 0000-0003-0699-2381
Louise RandallPopulation Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.
Marc SealDevelopmental Imaging, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.
Katherine JohnsonMelbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Victoria, 3010, Australia.ORCID 0000-0002-2029-163X
Stefan BodeMelbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Victoria, 3010, Australia.ORCID 0000-0002-0258-7795
Martin N MwangiTraining and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.ORCID 0000-0002-8358-4448
Sant-Rayn PasrichaPopulation Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.
Sabine BraatPopulation Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.ORCID 0000-0003-1997-3999
Kamija S PhiriTraining and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.
University of Malawi · MWThe University of Melbourne · AUWalter and Eliza Hall Institute of Medical Research · AUMuseum of Malawi · MWMeander Medisch Centrum · NLMicron (United States) · USMurdoch Children's Research Institute · AUThe Royal Melbourne Hospital · AU

Funding

Gates Foundation INV-004505
6 · The paper itself

Abstract

Background: Anemia affects 40% of pregnant women globally, leading to maternal mortality, premature birth, low birth weight, and poor baby development. Iron deficiency causes over 40% of anemia cases in Africa. Oral iron supplementation is insufficient for Low-and-Middle-Income-Countries (LMICs) to meet current WHO targets. We hypothesized that a single intravenous dose of Ferric Carboxymaltose (FCM) may be more effective than oral iron treatment for anemia recovery, particularly in these settings where women present late for antenatal care. Methods: This is a two-arm parallel open-label individual-randomized controlled trial in third trimester, in malaria Rapid Diagnostic Test-negative pregnant women with moderate or severe anemia - capillary hemoglobin <10 g/dL - who are randomized to receive either parenteral iron - with FCM - or standard-of-care oral iron for the remainder of pregnancy. This is the sister trial to the second-trimester Discussion: This study will determine whether FCM, delivered within primary health centers, is effective, safe and feasible for treating moderate to severe anemia in third-trimester pregnant Malawian women. This intervention could have long-term benefits for maternal and child health, resulting in improved survival and child development.

Indexed as

AnemiaAnemia, Iron-DeficiencyFerric CompoundsChildFemaleHemoglobinsHumansInfant, NewbornIronMalawiMaltosePregnancyPregnancy Trimester, ThirdPregnant PeopleRandomized Controlled Trials as Topicferric carboxymaltoseFerric CompoundsHemoglobinsIronMaltoseAnemiaBirth weightIronIron-deficiencyPregnancyRCT

Identifiers

PMID38343768
PMCPMC10858019
OpenAlexW4389879180

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.