Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial

Pasricha, Sant‐Rayn; Mwangi, Martin N; Moya, Ernest; Ataíde, Ricardo; Mzembe, Glory; Harding, Rebecca; Truwah, Zinenani; Larson, Leila M; Demir, Ayşe; Nkhono, William; Chinkhumba, Jobiba; Simpson, Julie A.; Clucas, Danielle; Stones, William; Braat, Sabine; Phiri, Kamija S.

doi:10.1016/s0140-6736(23)00278-7

Cited by 24 publications

(15 citation statements)

References 47 publications

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“…The review included 8061 women meeting the inclusion and exclusion criteria. Out of 34 selected studies, 20 24 , 32 – 49 are from Low- and Middle-income countries like India, Pakistan, Bangladesh and Malawi. All the selected 34 studies are randomised controlled trials and were available in full text for review.…”

Section: Resultsmentioning

confidence: 99%

“…Randomization process was detailed in 22 studies 18 , 19 , 54 – 73 , while insufficient information was available from ten studies 74 – 83 , no information from two studies 84 , 85 while only one study reported the selection through non-random allocation sequence 86 . Allocation concealment was described adequately using opaque envelopes in 12 studies 18 , 55 , 60 , 62 – 66 , 68 , 69 , 72 , 76 , while remaining did not indicate allocation concealment in their studies.…”

Section: Resultsmentioning

confidence: 99%

“…Two studies reported blinding of data analysts or statisticians 60 , 68 . One reported blinding of only outcome assessors 18 .…”

Section: Resultsmentioning

confidence: 99%

“…A Cochrane review by Reveiz L reported that there is insufficient evidence on impact of IV and oral iron treatment during pregnancy on maternal and neonatal clinical outcomes 17 . Although several studies indicate that IV preparations may have better outcomes, emerging evidence suggests no major difference in clinical outcomes 18 , 19 . Previously published meta-analysis 20 demonstrated that iron sucrose is more effective in improving the haemoglobin concentration; however there is a dearth of evidence on clinical measures.…”

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confidence: 99%

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Clinical outcome post treatment of anemia in pregnancy with intravenous versus oral iron therapy: a systematic review and meta-analysis

Pandey,

Gautam,

Tolani

et al. 2024

Sci Rep

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Oral iron therapy is often the most common way of treating anaemia; however intravenous iron is considered effective due to rapid iron replenishment. We have dearth of evidence on clinical outcomes post treatment of anaemia. We have searched studies published in English in PubMed, Cochrane, Scopus, ProQuest, and Google Scholar. Our study analysed the clinical outcomes amongst neonates and mother and the adverse events post treatment and assessed the mean change in maternal haemoglobin concentration in both the groups. Forest plots for the clinical outcomes are presented. From a total of 370 studies, 34 Randomized and quasi experimental studies comparing clinical outcomes post-treatment of anaemia in pregnancy were included for quantitative evidence synthesis. Pooled results of maternal clinical outcomes using random effect model [OR: 0.79 (95% CI 0.66; 0.95); 10 outcomes; 17 studies] showed statistically significant difference among both the groups [Moderate quality evidence]; however no significant difference [OR: 0.99 (95% CI 0.86; 1.14); 7 outcomes; 8 studies] have been observed for neonatal complications [Low quality evidence]. The study found that pregnant women receiving IV iron were significantly less likely to experience adverse events as compared with those receiving oral iron [OR 0.39; (95% CI 0.26–0.60)]; 34 studies; 13,909 women; [Low quality evidence]. Findings from meta-regression analysis showed that IV iron is more likely to reduce maternal complications by 21% compared to oral iron. Increase in odds of adverse maternal outcomes was observed due to increase in gestational age and publication year but no effect for the type of drug used. IV iron increases Hb more and at a higher pace than oral iron. Intravenous iron is more likely to avert adverse maternal outcomes and adverse reactions. However, there is no conclusive evidence on its effectiveness on individual maternal outcome or neonatal outcome/s. Protocol registered with PROSPERO CRD42022368346).

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Two studies reported blinding of data analysts or statisticians 60 , 68 . One reported blinding of only outcome assessors 18 .…”

Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

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Clinical outcome post treatment of anemia in pregnancy with intravenous versus oral iron therapy: a systematic review and meta-analysis

Pandey,

Gautam,

Tolani

et al. 2024

Sci Rep

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“…Furthermore, the observations in our study of a minimal association between hemoglobin and iron biomarkers could explain why trials based on hemoglobin alone as a marker of iron deficiency anemia for assessment of outcome of supplementation are not effective. For example, a recent trial by Pasricha et al 31 could not show differences in hemoglobin as a primary outcome when comparing anemic pregnant women receiving intravenous iron with those receiving oral iron, although a significant correction of iron deficiency and overall reduction of iron deficiency anemia was noted in the group receiving intravenous iron.…”

Section: Discussionmentioning

confidence: 97%

The complex relationship between iron status and anemia in pregnant and postpartum women in India: Analysis of two Indian study cohorts of uncomplicated pregnancies

Nair,

Choudhury,

Rani

et al. 2023

American J Hematol

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Low hemoglobin is widely used as an indicator of iron deficiency anemia in India and other low‐and‐middle income counties, but anemia need not accurately reflect iron deficiency. We examined the relationship between hemoglobin and biomarkers of iron status in antenatal and postnatal period. Secondary analysis of uncomplicated singleton pregnancies in two Indian study cohorts: 1132 antenatal women in third trimester and 837 postnatal women 12–72 h after childbirth. Associations of hemoglobin with ferritin in both data sets, and with sTfR, TSAT, and hepcidin in the postnatal cohort were examined using multivariable linear regression. Multinomial logistic regression was used to examine the association between severity of anemia and iron status. Regression models were adjusted for potential confounders. Over 55% of the women were anemic; 34% of antenatal and 40% of postnatal women had low ferritin, but 4% antenatal and 6% postnatal women had high ferritin. No evidence of association between hemoglobin and ferritin was observed (antenatal: adjusted coefficient [aCoef] −0.0004, 95% confidence interval [CI] −0.001, 0.001; postnatal: aCoef −0.0001, 95% CI −0.001, 0.001). We found a significant linear association of hemoglobin with sTfR (aCoef −0.04, 95% CI −0.07, −0.01), TSAT (aCoef −0.005, 95% CI −0.008, −0.002), and hepcidin (aCoef 0.02, 95% CI 0.02, 0.03) in postnatal women. Likelihood of low ferritin was more common in anemic than non‐anemic women, but high ferritin was also more common in women with severe anemia in both cohorts. Causes of anemia in pregnant and postpartum women in India are multifactorial; low hemoglobin alone is not be a useful marker of iron deficiency.

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Iron deficiency, pregnancy, and neonatal development

Ataíde

Fielding

Pasricha

et al. 2023

Intl J Gynecology & Obste

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Anemia affects 36% of pregnant women worldwide. Of those affected, around 40% is due to iron deficiency (ID). Iron is an essential micronutrient involved in vital processes such as erythropoiesis, immune responses, and importantly—during pregnancy—placental and fetal development. Although menstrual bleeding can impact the incidence of ID even before the onset of pregnancy, this narrative review is pregnancy focused and will explore the impact of ID on placental development and iron uptake, fetal development and immunity, and maternal and infant susceptibility to infection. Although there have been advances in this area of research, much is needed to understand the regulation of iron and the effects of ID during pregnancy. Notably, more human studies are essential to generate the best evidence to advance strategies to reduce the incidence of ID during pregnancy to improve maternal, neonatal, and infant health.

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Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial

Cited by 24 publications

References 47 publications

Clinical outcome post treatment of anemia in pregnancy with intravenous versus oral iron therapy: a systematic review and meta-analysis

Clinical outcome post treatment of anemia in pregnancy with intravenous versus oral iron therapy: a systematic review and meta-analysis

The complex relationship between iron status and anemia in pregnant and postpartum women in India: Analysis of two Indian study cohorts of uncomplicated pregnancies

Iron deficiency, pregnancy, and neonatal development

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