Reported Outcomes in Perinatal Iron Deficiency Anemia Trials: A Systematic Review

Ann Kinga Malinowski1,2,3, Rohan D'Souza4,5,6, Khalid S Khan7

  • 1Division of Maternal-Fetal Medicine, Sinai Health System, Department of Obstetrics and Gynaecology, Toronto, Ontario, Canada, ann.malinowski@sinaihealthsystem.ca.

Insights

Iron deficiency in pregnancy impacts maternal and infant health. This study reviewed perinatal iron trials, identifying numerous outcomes but highlighting significant variation in reporting to guide future research and core outcome set development.

Area of Science:

  • Obstetrics and Gynecology
  • Hematology
  • Public Health

Background:

  • Iron deficiency (ID) and iron deficiency anemia (IDA) are significant global health issues with adverse perinatal outcomes.
  • Current international strategies for prevention and treatment lack consensus, partly due to inconsistent outcome reporting in clinical trials.
  • This study aimed to systematically assess outcome reporting in perinatal iron intervention trials as a foundational step for developing a core outcome set (COS).

Approach:

  • A systematic literature search was conducted across major databases (MEDLINE, EMBASE, Cochrane, CINAHL) from January 2000 to April 2016.
  • Included trials focused on pregnant or postpartum women with confirmed ID/IDA.
  • Data extraction, quality assessment, and tabulation of outcome definitions and measurement methods were performed by two independent reviewers.

Key Points:

  • 33 randomized controlled trials were identified from 7,046 citations.
  • Sixty-nine distinct outcomes were reported, grouped into 8 domains.
  • While 76% of studies had high methodological quality, only 12% demonstrated high reporting quality, with significant variation in outcome definition, timing, and measurement.

Conclusions:

  • This review compiles a comprehensive list of outcomes from perinatal iron interventions for ID/IDA.
  • The findings underscore the heterogeneity in outcome reporting, emphasizing the need for standardization.
  • This work provides essential groundwork for the development of a core outcome set (COS) to improve the consistency and comparability of future research in this area.
Abstract

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