Evidence map›Paper›PMID 36368479›Full record

ArticleContemporary clinical trials2022

Protocol for a multicenter, double-blinded placebo-controlled randomized controlled trial comparing intravenous ferric derisomaltose to oral ferrous sulfate for the treatment of iron deficiency anemia in pregnancy: The IVIDA2 trial.

Adam K Lewkowitz, Molly J Stout, Ebony B Carter, Crystal F Ware, Tracy L Jackson, Viren D'Sa, Sean Deoni, Anthony O Odibo, Riley Gopalakrishnan, Jingxia Liu and 3 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Identifying and treating iron deficiency anemia in pregnancy.Hematology. American Society of Hematology. Education Program · 2023
    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

13 authors at 5 institutions in 1 country.

Adam K LewkowitzDepartment of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI, USA. Electronic address: Alewkowitz@kentri.org.
Molly J StoutDepartment of Obstetrics and Gynecology, University of Michigan School of Medicine, Ann Arbor, MI, USA.
Ebony B CarterDepartment of Surgery, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Crystal F WareDepartment of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI, USA.
Tracy L JacksonDepartment of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI, USA.
Viren D'SaDepartment of Pediatrics, Warren Alpert Medical School at Brown University, Providence, RI, USA.
Sean DeoniBill & Melinda Gates Foundation, Seattle, WA, USA.
Anthony O OdiboDepartment of Surgery, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Riley GopalakrishnanDepartment of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI, USA; Department of Surgery, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Jingxia LiuDepartment of Surgery, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Dwight J RouseDepartment of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI, USA.
Michael AuerbachDepartment of Medicine, Georgetown University School of Medicine, Washington, DC, USA.
Methodius G TuuliDepartment of Obstetrics and Gynecology, Warren Alpert Medical School at Brown University, Providence, RI, USA.
Brown University · USWashington University in St. Louis · USBill & Melinda Gates Foundation · USGeorgetown University · USMichigan Medicine · US

Funding

A Multicenter Randomized Trial of IV vs Oral Iron for Treating Iron-Deficiency Anemia in PregnancyR01HD105855 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI Methodius Gamuo Tuuli · 2022 to 2026
$2.7M
NICHD NIH HHS R01 HD105855
6 · The paper itself

Abstract

backgroundIron deficiency anemia (IDA) is common during pregnancy and associated with adverse maternal and neonatal outcomes. Treatment with iron supplementation is recommended during pregnancy, but the optimal delivery route is unclear. Oral iron risks has high risk of gastrointestinal side effects and low absorption. Intravenous iron is infused directly but is expensive. The American College of Obstetricians and Gynecologists currently recommends oral iron to treat IDA in pregnancy with intravenous iron reserved as second-line therapy, if needed. This approach is associated with persistent anemia, increasing the risk of peripartum blood transfusion. We aim to provide data on optimal route of iron repletion for IDA in pregnancy.

methodsIn IVIDA2, a double-blind, placebo controlled, multicenter randomized trial in the United States, 746 pregnant people with moderate-to-severe IDA (hemoglobin <10 g/dL and ferritin <30 ng/mL) at 24-28 weeks' gestation will be randomized 1:1 to either a single 1000 mg dose of intravenous ferric derisomaltose and oral placebo (1-3 times daily) or a single placebo infusion with 1-3 times daily 325 mg ferrous sulfate (65 mg elemental iron) tablet. The primary outcome is peripartum blood transfusion (blood transfusion from delivery to 7 days postpartum). Secondary outcomes include adverse medication reactions, maternal and neonatal hematologic indices, and offspring neurodevelopment. ETHICS AND DISSEMINATION: A central ethical review board-Advarra-granted ethical approval (Pro00060930). Participating centers-Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of Ethics and dissemination: A central ethical review board-Advarra-granted ethical approval (Pro00060930). Participating centers-Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of.

Indexed as

Anemia, Iron-DeficiencyIron DeficienciesDisaccharidesFemaleFerric CompoundsFerrous CompoundsHumansInfantInfant, NewbornIronMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicDisaccharidesFerric Compoundsferric derisomaltoseFerrous Compoundsferrous sulfateIronFerric derisomaltoseFerrous sulfateIron deficiency anemiaPregnancyRandomized controlled trial

Identifiers

PMID36368479
PMCPMC9729403
OpenAlexW4308518060

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.