Evidence map›Paper›PMID 36107229›Full record

Trial reportArchives of gynecology and obstetrics2023

Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial.

Rebecka Hansen, Veronika Markova Sommer, Anja Pinborg, Lone Krebs, Lars Lykke Thomsen, Torben Moos, Charlotte Holm

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Archives of gynecology and obstetrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
3.8field-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.

NCT03188445 phase4completednot on this map

Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial

TypeinterventionalSponsorPharmacosmos A/SRan2017 to 2020Enrolled201ConditionsIron Deficiency Anemia of PregnancyArmsIron Isomaltoside 1000, ferrous fumarate with ascorbic acid
NCT06366698 phase3unknown statusnot on this map

Randomized Control Trial: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy

TypeinterventionalSponsorArrowhead Regional Medical CenterRan2023 to 2025Enrolled900ConditionsIron Deficiency Anemia of PregnancyArmsVenofer 200 MG Per 10 ML Injection, Ferrous sulfate
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

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  16. Identifying and treating iron deficiency anemia in pregnancy.Hematology. American Society of Hematology. Education Program · 2023
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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

7 authors at 4 institutions in 1 country.

Rebecka HansenDepartment of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
Veronika Markova SommerDepartment of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
Anja PinborgFertility Department, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Lone KrebsDepartment of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
Lars Lykke ThomsenDepartment of Clinical and Non-Clinical Research, Pharmacosmos A/S, Holbæk, Denmark.
Torben MoosNeurobiology and Drug Delivery, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
Charlotte HolmDepartment of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark. charlotteholm@dadlnet.dk.ORCID 0000-0003-2278-2384
University of Copenhagen · DKHvidovre Hospital · DKAalborg University · DKPharmacosmos (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron (ferrous fumarate) in women 14-21 weeks pregnant with persistent iron deficiency (ferritin < 30 µg/L).

methodsIn a single-centre, open-label, randomised controlled trial at a Danish hospital, women with persistent iron deficiency after routine oral iron treatment were allocated to receive 1000 mg IV iron (single-dose) or 100 mg elemental oral iron daily. Outcomes were assessed during an 18-week follow-up period. The primary endpoint was the proportion of non-anaemic (haemoglobin [Hb] ≥ 11 g/dL) women throughout follow-up. Other outcomes included changes in haematological parameters, patient-reported fatigue, and quality of life (QoL). Safety was assessed by recording adverse events.

resultsFrom July 2017 to February 2020, 100 women were randomised to IV iron and 101 to oral iron. Throughout follow-up, 91% of women were non-anaemic in the IV iron group compared with 73% in the oral iron group (18% difference [95% confidence interval 0.10-0.25]; p < 0.001). The mean Hb increase was significantly greater with IV iron versus oral iron at Weeks 6 (0.4 versus - 0.2 g/dL; p < 0.001), 12 (0.5 versus 0.1 g/dL; p < 0.001), and 18 (0.8 versus 0.5 g/dL; p = 0.01). Improvements in fatigue and QoL were greater with IV iron versus oral iron at Weeks 3 and 6. The incidence of treatment-related adverse events was comparable between treatment groups.

conclusionIV iron was superior in preventing anaemia compared with oral iron in pregnant women with persistent iron deficiency; biochemical superiority was accompanied by improved fatigue and QoL. CLINICAL

trial registrationEuropean Clinical Trials Database: EudraCT no.: 2017-000776-29 (3 May 2017); ClinicalTrials.gov: NCT03188445 (13 June 2017). The trial protocol has been published: https://dx.doi.org/10.1186%2Fs13063-020-04637-z .

Indexed as

Anemia, Iron-DeficiencyFerric CompoundsTrace ElementsAdministration, IntravenousAdministration, OralAdultDenmarkDisaccharidesFemaleFerrous CompoundsHumansPregnancyPregnancy Trimester, SecondTreatment OutcomeDisaccharidesFerric Compoundsferric derisomaltoseFerrous Compoundsferrous fumarateTrace ElementsAnaemiaIntravenous ironIron deficiencyPregnancy

Identifiers

PMID36107229
PMCPMC10435604
OpenAlexW4295897834

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.