Evidence map›Paper›PMID 36047598›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2023

Testing equivalence of two doses of intravenous iron to treat iron deficiency in pregnancy: A randomised controlled trial.

Bernd Froessler, Klaus Oliver Schubert, Peter Palm, Richard Church, Natalie Aboustate, Thu-Lan Kelly, Gus A Dekker, Nicolette A Hodyl

Open access · greenAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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

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

  1. Pooled it
  2. Trial
  3. 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

8 authors at 3 institutions in 1 country.

Bernd FroesslerDepartment of Anaesthesia, Northern Adelaide Local Health Network, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.ORCID 0000-0003-3755-8609
Klaus Oliver SchubertDiscipline of Psychiatry, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
Peter PalmDepartment of Anaesthesia, Northern Adelaide Local Health Network, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.
Richard ChurchDepartment of Anaesthesia, Northern Adelaide Local Health Network, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.
Natalie AboustateRobinson Research Institute, North Adelaide, South Australia, Australia.
Thu-Lan KellyQuality Use of Medicines Pharmacy Research Centre, University of South Australia, Clinical and Health Sciences, Adelaide, South Australia, Australia.
Gus A DekkerDepartment of Obstetrics and Gynaecology, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.
Nicolette A HodylAdelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
Lyell McEwin Hospital · AUUniversity of South Australia · AUHunter Medical Research Institute · AU

Funding

National Blood Authority 117University of Adelaide
6 · The paper itself

Abstract

objectiveTo test the equivalence of two doses of intravenous iron (ferric carboxymaltose) in pregnancy.

designParallel, two-arm equivalence randomised controlled trial with an equivalence margin of 5%.

settingSingle centre in Australia. POPULATION: 278 pregnant women with iron deficiency.

methodsParticipants received either 500 mg (n = 152) or 1000 mg (n = 126) of intravenous ferric carboxymaltose in the second or third trimester.

main outcome measuresThe proportion of participants requiring additional intravenous iron (500 mg) to achieve and maintain ferritin >30 microg/L (diagnostic threshold for iron deficiency) at 4 weeks post-infusion, and at 6 weeks, and 3-, 6- and 12-months postpartum. Secondary endpoints included repeat infusion rate, iron status, birth and safety outcomes.

resultsThe two doses were not equivalent within a 5% margin at any time point. At 4 weeks post infusion, 26/73 (36%) participants required a repeat infusion in the 500-mg group compared with 5/67 (8%) in the 1000-mg group: difference in proportions, 0.283 (95% confidence interval [CI] 0.177-0.389). Overall, participants in the 500-mg arm received twice the repeat infusion rate (0.81 [SD = 0.824] versus 0.40 [SD = 0.69], rate ratio 2.05, 95% CI 1.45-2.91).

conclusionsAdministration of 1000 mg ferric carboxymaltose in pregnancy maintains iron stores and reduces the need for repeat infusions. A 500- mg dose requires ongoing monitoring to ensure adequate iron stores are reached and sustained.

Indexed as

Anemia, Iron-DeficiencyIron DeficienciesAdministration, IntravenousFemaleFerric CompoundsHumansIronMaltosePregnancyferric carboxymaltoseFerric CompoundsIronMaltoseantenatal carehaematology: anaemiamedical disorders in pregnancyobstetric haemorrhagerandomised controlled trialsrisk management

Identifiers

PMID36047598
PMCPMC10087028
OpenAlexW4294085254

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.