Welcome! Daily oral iron supplementation during pregnancy: What's the

evidence?

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What’s the evidence? Peña-Rosas J.P., De-Regil L.M., Garcia-Casal M.N., & Dowswell T. (2015). Daily oral iron supplementation during pregnancy. Cochrane Database of Systematic Reviews, 2015(7), CD004736. http://www.healthevidence.org/view-article.aspx?a=20405

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Poll Question #4

Dr. Luz Maria De-RegilDirector of Research and Evaluation at the Micronutrient Initiative

Daily oral iron supplementation improves health outcomes for pregnant womenA.Strongly agreeB.AgreeC.NeutralD.DisagreeE.Strongly disagree

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Poll Question #5

ReviewPeña-Rosas J.P., De-Regil L.M., Garcia-Casal M.N., & Dowswell T. (2015). Daily oral iron supplementation during pregnancy. Cochrane Database of Systematic Reviews, 2015(7), CD004736.

Review focus:P Pregnant women of any gestational age and

parity

I Daily oral use of iron supplements, either alone or in conjunction with folic acid or with other vitamins and minerals

C Same supplement without iron/ no treatment/ placebo

O - Maternal: Maternal anaemia, iron deficiency and iron deficiency anaemia at term - Infant: Low birth weight, premature birth, Hb concentrations in first 6 months

Iron deficiency anaemia• Iron deficiency is the most common nutrient

deficiency among women• 38.2% of pregnant women suffer anaemia• Main causes:

– Poor diet in absorbable iron– Uncover increased iron requirement – Iron loss due to parasitic infections (e.g. hookworms)– Other blood losses

Global landscape of anaemia

Source: WHO. Global prevalence of anaemia in 2011. Geneva: World Health Organizaiton, 2015

Iron supplementation• Iron supplementation for pregnant women has

been used extensively in most low- and middle- income countries

• Inclusion of folic acid is also recommended because of increase requirements in pregnancy due to rapidly dividing cells in the fetus in increased urinary losses

• Iron supplementation has been used in variety of doses and frequencies

Recommendations for iron supplementation• Daily dose of 30-60 mg of elemental iron and 0.4

mg of folic acid and to start as soon as possible (WHO)

• Anaemia in populations >40%: Daily dose of 60 mg of elemental iron is preferred over a lower dose (INACG )

• Women with anaemia in clinical settings: Daily dose of 120 mg of elemental iron and 0.4 mg supplementation until her Hb recovers (WHO)

Why is this review important?• Impact of iron supplementation under field

conditions is limited• Effectiveness of iron supplementation have been

evaluated mostly in terms of improvement of haemoglobin (Hb), rather than improvements of maternal and infant health

• Limited results in malaria settings• These are the results of an update of the

systematic review done in 2012

ObjectiveTo assess the effects of daily oral iron

supplementations by pregnant women, either alone or in conjunction with folic acid or with other

vitamins and minerals as a public health intervention in antenatal care.

PICO QUESTION

MethodologyIncluded studiesRandomized, cluster-randomized and quasi-randomized trials

Types of participantsPregnant women of any gestational age and parity

ComparisonsAny supplements containing iron vs Same supplement without iron/no

treatment/ placeboAny supplements containing IFA vs Same supplement without IFA

Supplementation with iron alone vs No treatment/placebo

Supplementation with IFA vs No treatment/placebo

Supplementation with IFA vs FA alone

Supplementation with iron and other vitamins

vs Same other vitamins without iron

Supplementation with IFA acid+ other vitamins and minerals

vs Same FA and other vitamins without iron

Supplementation with IFA +other vitamins

vs Same other vitamins and minerales withou IFA

OutcomesPrimary outcomes

Infant MaternalLow birth weight Maternal anaemia at term

Birthweight Maternal iron deficiency at termPreterm birth Maternal iron deficiency anaemia (IDA) at term

Neonatal death Maternal deathCongenital anomalies Side effects

Severe anaemia at any time during second or third trimester

Clinical malariaInfection during pregnancy

Secondary outcomesInfant Maternal

Very low birthweight Maternal anaemia at or near termVery premature birth Maternal iron deficiency at or near term

Hb concentration within the first 6 months Maternal IDA at or near term

Ferritin concentration with the first 6 months Maternal Hb concentration at or neat termDevelopment and monitor skills Maternal Hb concentration within one month postpartum

Electronic searches• Cochrane Central Register of Controlled Trials

(CENTRAL)• MEDLINE• EMBASE• CINAHL• Hand search of 30 journals and proceedings of

major conference proceedings

Study flow diagram

The review included studies across the globe:

•24 trials from Europe•11 in the Americas•4 in Africa•18 in Asia•3 in Australia

Characteristics assessing risk of bias• Random sequence generation (selection bias)• Allocation concealment (selection bias)• Blinding of participants and personal

(performance bias)• Blinding of outcome assessment (detection bias)• Incomplete outcome data (attrition bias)• Other bias

Example

Butler 1967

Summary of risk of bias for all included studies

Summary risk of bias for individual studies

GRADE – grading the quality of evidence• Assess the quality of the evidence quality so one

can be confident that an estimate of effect or association is close to the quantity of specific interest.

Level of quality depending of study design, limitations,

indirectness, inconsistency of

results, imprecision of results or

publication bias

ResultsMaternal outcomes

•Reduced maternal anaemia at term by 70% (RR 0.30; (0.19-0.46), 14 trials, 2199 women, low quality evidence)

•Reduced Iron-deficiency anaemia at term by 67% (RR 0.33; (0.16 -0.69), six trials, 1088 women

•Reduced Iron deficiency at term by 57% (RR 0.43; (0.27 -0.66), seven trials, 1256 women, low quality evidence)

No clear differences between groups:

•For severe anaemia in the second trimester: RR 0.22 (0.01 -3.20), nine trials, 2125 women, very low quality evidence

•For severe anaemia in the third trimester: RR 1.21(0.33 to 4.46), one trial, 727 women, low quality evidence

•For maternal mortality: (RR 0.33; 95% CI 0.01 to 8.19, two trials, 12,560 women, very low quality evidence)

•Side effects: (RR 1.29( 0.83 -2.02), 11 trials, 2423 women, very low quality evidence)

•Women receiving iron were on average more likely to have higher Hb concentrations at term and in the postpartum period, but were at increased risk of Hb concentrations greater than 130 g/L during pregnancy, and at term.

Infant outcomesComparing with controls:•Low birthweight newborns (8.4% versus 10.3%, average RR 0.84(0.69 -1.03), 11 trials, 17,613 women, low quality evidence)•Preterm babies (RR 0.93 (0.84 -1.03), 13 trials, 19,286 women, moderate quality evidence). •They appeared to also deliver slightly heavier babies (MD 23.75 (-3.02 to 50.51, 15 trials, 18,590 women, moderate quality evidence).

None of these results were statistically significant.

Infant outcomesNo clear differences between groups:•For neonatal death (RR 0.91(0.71 -1.18), four trials, 16,603 infants, low quality evidence)• Congenital anomalies (RR 0.88, 95% CI 0.58 to 1.33, four trials, 14,636 infants, low quality evidence)

Malaria settings• Twenty-three studies malaria risk in 2011• Only two of these studies reported malaria

outcomes• No evidence was found that iron supplementation

increases placental malaria

Conclusions: Daily oral iron supplementation

Women consuming daily oral iron supplementation have:•Lower risk of anaemia at term•Higher haemoglobin (Hb) concentrations at term and six weeks postpartum•Higher risk of high Hb concentrations during the second and third trimesters of pregnancy

Infants from mothers consuming daily oral supplementation have: •Borderline lower risk of delivering low birthweight babies•Borderline lower risk of giving birth to infants less than 37 weeks’ gestation•Lower risk of giving birth to infants less than 34 weeks’ gestation

OVERALL SUMMARY • Supplementation reduces the risk of maternal anaemia and

iron deficiency in pregnancy.• The positive effect on other maternal and infant outcomes

is less clear. • Implementation of iron supplementation recommendations

may produce heterogeneous results depending on the populations' background risk for low birthweight and anaemia, as well as the level of adherence to the intervention.

Daily oral iron supplementation improves health outcomes for pregnant womenA.Strongly agreeB.AgreeC.NeutralD.DisagreeE.Strongly disagree

48

Poll Question #6

Poll Question #7Do you agree with the findings of this review?A.Strongly agreeB.AgreeC.NeutralD.DisagreeE.Strongly disagree

Questions?

A Model for Evidence-Informed Decision

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National Collaborating Centre for Methods and Tools. (revised 2012). A Model for Evidence-Informed Decision-Making in Public Health (Fact Sheet). [http://www.nccmt.ca/pubs/FactSheet_EIDM_EN_WEB.pdf]

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