A randomized controlled trial comparing the efficacy, tolerability, and cost of oral iron preparations in iron‐deficiency anemia in pregnancy

Author(s):  
Nanda Gamad ◽  
Pradip Kumar Saha ◽  
Prashant Sharma ◽  
Vanita Suri ◽  
Amitava Chakrabarti ◽  
...  
Author(s):  
Adam K. Lewkowitz ◽  
Molly J. Stout ◽  
Emily Cooke ◽  
Seon C. Deoni ◽  
Viren D'Sa ◽  
...  

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points


2019 ◽  
Vol 99 (1) ◽  
pp. 57-63 ◽  
Author(s):  
Rahul Kaundal ◽  
Prateek Bhatia ◽  
Arihant Jain ◽  
Ankur Jain ◽  
Ram V. Nampoothiri ◽  
...  

2017 ◽  
Vol 66 (5) ◽  
pp. 56-63
Author(s):  
Anna S. Atajanyan

The review article defines iron deficiency anemia, the mechanisms determining iron deficiency in pregnancy, the complications of pregnancy, childbirth and the postpartum period, the methods of correction and prevention of iron deficiency, including a modern alternative to oral iron intake-its intravenous forms, which contribute to a rapid increase of iron levels. And also do not have toxicity and are easily tolerated.


2018 ◽  
Vol 36 (04) ◽  
pp. 366-376 ◽  
Author(s):  
Richard Burwick ◽  
Shravya Govindappagari

Objective To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the benefits of intravenous (IV) iron in pregnancy. Study Design Systematic review was registered with PROSPERO and performed using PRISMA guidelines. PubMed, MEDLINE, Web of Science, ClinicalTrials.gov, Cochrane Library, and Google Scholar were searched. Eleven RCTs, comparing IV to oral iron for treatment of iron-deficiency anemia in pregnancy, were included. Meta-analyses were performed with Stata software (College Station, TX), utilizing random effects model and method of DerSimonian and Laird. Outcomes were assessed by pooled odds ratios (OR) or pooled weighted mean difference (WMD). Sensitivity analyses were performed for heterogeneity. Results We found that pregnant women receiving IV iron, compared with oral iron, had the following benefits: (1) Achieved target hemoglobin more often, pooled OR 2.66 (95% confidence interval [CI]: 1.71–4.15), p < 0.001; (2) Increased hemoglobin level after 4 weeks, pooled WMD 0.84 g/dL (95% CI: 0.59–1.09), p < 0.001; (3) Decreased adverse reactions, pooled OR 0.35 (95% CI: 0.18–0.67), p = 0.001. Results were unchanged following sensitivity analyses. Conclusion In this meta-analysis, IV iron is superior to oral iron for treatment of iron-deficiency anemia in pregnancy. Women receiving IV iron more often achieve desired hemoglobin targets, faster and with fewer side effects.


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