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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.
Background/Aims:
Iron deficiency (ID) and iron deficiency anemia (IDA) are global health concerns associated with adverse perinatal effects. Despite efforts taken at the international level, there is no consensus on unified prevention/treatment strategies, largely stemming from inconsistencies of outcome reporting. Our objective was to comprehensively assess outcome reporting perinatal iron intervention trials as Phase 1 of core outcome set (COS) development to inform future research.
Methods:
Systematic search in MEDLINE, EMBASE, Cochrane Databases, and CINAHL (January 2000 - April 2016), with inclusion of trials involving pregnant or postpartum women with ID/IDA confirmed before recruitment. Articles were independently screened and selected by 2 reviewers; data were extracted in duplicate. Quality was assessed using published scoring systems. Outcome definitions and measurement methods were tabulated.
Results:
Of 7,046 citations, 33 randomized controlled trials were included. Sixty-nine reported outcomes were categorized into 8 domains. High methodological quality characterized 25 (76%) studies. Reporting quality was low in 16 (49%), moderate in 13 (39%), and high in 4 (12%) studies. Variation was greatest for outcome definition, timing of assessment and measurement methods.
Conclusion:
This review identifies a comprehensive long-list of outcomes reported of perinatal iron interventions for ID/IDA. Beyond highlighting existing variation in outcome reporting, it provides a foundation for development of a COS for future trials.
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