Meta-analysisindependent cross-checkabstract checked★ key study I-SUP-101 in-depth review

Iron tablets in pregnancy: updated Cochrane review

Daily oral iron supplementation during pregnancy.

Overview

Finkelstein JL et al.. Cochrane Database Syst Rev 2024 · PMID 39145520 · DOI 10.1002/14651858.CD004736.pub6

In 57 trials with almost 49,000 pregnant women, daily iron reduced iron-deficiency anaemia at term from 18.4% to 5.0% and slightly reduced low birthweight.

Does the study support the specific claim? No · Methodological quality: high

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

To summarise all trials of daily iron tablets in pregnancy.

How was the study done?

Systematic review and meta-analysis of randomised trials (Cochrane, 2024).

How many people, animals or samples were studied?

57 trials, 48,971 women.

What was actually found?

Less anaemia and iron deficiency at term; slightly fewer low-birthweight babies; no clear effect on deaths or preterm birth.

How large was the observed effect?

Iron-deficiency anaemia RR 0.41 (0.26-0.63); anaemia RR 0.30 (0.20-0.47); low birthweight RR 0.84 (0.72-0.99).

What do the results mean in everyday life?

Iron tablets in pregnancy work for their main purpose: preventing and correcting iron deficiency and anaemia.

What are the study's limitations?

Mostly preventive use; harms poorly reported; heterogeneity.

What does it say about Elawady's specific claim?

Contradicts the claim that iron supplements are forbidden or unnecessary in pregnancy.

Do the results apply to Germany and Europe?

Applicable.

What can explicitly not be concluded from this study?

It does not show that every pregnant woman needs iron, nor that iron prevents deaths.

Scientific in-depth review

1. Full reference

Authors
Finkelstein JL et al.
Journal
Cochrane Database Syst Rev
Year
2024
Identifier
PMID 39145520 DOI 10.1002/14651858.CD004736.pub6 · PMC11325660
Verification
verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
Retracted
no
Corrections

none Crossref update-to: new version of an earlier Cochrane review (not a retraction).

Extent checked
abstract only
Conflicts of interest and funding

COI statement in record: We certify that we have no affiliations with or involvement in any organisation or entity with a direct financial interest in the subject matter of the review (e.g. employment, consultancy, stock ownership, honoraria, expert testimony). Dr Julia L Finkelstein is a principal investigator on research ; funding listed: World Health Organization

2. Research question

Effects of daily oral iron (alone, with folic acid, or with other micronutrients) during pregnancy on maternal and infant outcomes.

3. Study design and population

Study design
Meta-analysis – Cochrane systematic review and meta-analysis of randomised and quasi-randomised trials (update of CD004736)
Population

Pregnant women of any age and parity

Country

Multinational (trials in high-, middle- and low-income countries; 19 in malaria-risk settings)

Period

Search to 18 January 2024

Sample size

57 trials, 48,971 women

Inclusion and exclusion criteria

Randomised or quasi-randomised trials of daily oral iron, iron + folic acid or iron + other micronutrients vs placebo/no iron; trustworthiness screening applied

4. Methods and endpoints

Exposure / intervention

Daily oral iron (with or without folic acid)

Comparator

Placebo or no iron (same co-interventions)

Endpoints

Maternal anaemia, iron deficiency, iron-deficiency anaemia at term, maternal death, adverse effects, low birthweight, preterm birth, neonatal death, congenital anomalies

Statistical methods

Random-effects meta-analysis (average treatment effect); GRADE for primary outcomes

5. Actual results

Results

Iron vs no iron: maternal anaemia at term 4.0% vs 7.4%, RR 0.30 (95% CI 0.20-0.47; 14 trials, 13,543 women; low certainty); iron deficiency at term 44.0% vs 66.0%, RR 0.51 (0.38-0.68; low); iron-deficiency anaemia at term 5.0% vs 18.4%, RR 0.41 (0.26-0.63; moderate); maternal death RR 0.57 (0.12-2.69; moderate, little or no difference); adverse effects 21.6% vs 18.0%, RR 1.29 (0.83-2.02; very low); low birthweight 5.2% vs 6.1%, RR 0.84 (0.72-0.99; moderate); preterm birth RR 0.93 (0.84-1.02; moderate); neonatal death RR 0.98 (0.77-1.24; low). Iron + folic acid vs folic acid: maternal anaemia at term 12.1% vs 25.5%, RR 0.44 (0.30-0.64; moderate); birthweight +57.73 g (7.66-107.79; moderate).

Absolute risks

Reported as event proportions (see results); recalculated ARR for iron-deficiency anaemia at term 13.4 percentage points (NNT about 7) and for low birthweight 0.9 points (NNT about 111) - illustrative (stats/C-SUP-09_finkelstein2024.py).

Authors' conclusion

Daily oral iron supplementation during pregnancy may reduce maternal anaemia and iron deficiency at term; for other maternal and infant outcomes there was little or no difference or the evidence was uncertain.

6. Strengths

  • Most recent Cochrane update (2024) with trustworthiness screening
  • Large number of trials and participants
  • GRADE certainty ratings per outcome

7. Weaknesses

  • Mainly preventive supplementation in mixed populations, not treatment of diagnosed anaemia
  • High heterogeneity; low certainty for some outcomes
  • Harms poorly reported (very low certainty)

8. Risk of bias

Orienting tool
AMSTAR 2
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
low
Rationale

Cochrane methods; pre-specified protocol; risk of bias in included trials varies; judgement simplified.

9. Assessment of the statistical interpretation

Relative effects on anaemia and iron deficiency are large and consistent; the low-birthweight benefit is small in absolute terms (about 1 percentage point). The crude ratio of pooled percentages for anaemia (0.54) differs from the random-effects RR (0.30), so absolute numbers should be read as illustrative.

10. Relevance to the specific claim

Directly contradicts the claim that iron supplements are useless or forbidden in pregnancy; supersedes I-SUP-04 (2015 version).

11. Independent contrary findings

Benefit on hard clinical outcomes (maternal death, preterm birth, neonatal death) is not shown; harms (gastrointestinal effects, high haemoglobin) are uncertain.

12. Transferability to Germany and Europe

Applicable; European antenatal care tests haemoglobin and treats iron deficiency.

13. Overall methodological judgement

High-quality evidence that iron supplementation prevents and corrects iron deficiency and anaemia in pregnancy; certainty for clinical outcomes is lower.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biaslow
Precision of resultsmoderate
Directnessdirect
Reproducibilityreplicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Effects of routine iron in iron-replete women in high-income settings; long-term child outcomes.

15. Linked fact checks