Randomized Controlled Trial Comparing Ferrous Sulfate and Iron Sucrose in Iron Deficiency Anemia in Pregnancy

Abstract

Introduction: Anemia among pregnant women is one of the major health concerns for healthcare workers. The management becomes a concern in the pregnancy where the question arises of which is better the intravenous iron sucrose or the oral ferrous sulfate tablets. To answer this, a randomized control trial comparing both the treatment options in a tertiary care government hospital was set up in the hilly terrains of India. This study discusses the effectiveness and practical aspect of using both, which seems to be the better out of both, and why.Methods: The study was conducted as a parallel-group, open-label randomized controlled trial (RCT) in the Department of Obstetrics and Gynecology of a tertiary care government hospital in India, with approximately 4,000 delivery loads annually. Ethical clearance was obtained from the institute's ethics committee (IEC), and the trial was registered with the Clinical Trial Registry of India (REF/2022/06/055013). Two hundred sixty-eight pregnant women between 18 and 45 years of age with moderate iron deficiency anemia (IDA) (hemoglobin (Hb) 7-9g/dl, microcytic-hypochromic, and serum ferritin <30ng/ml) were included in the study. Patients were randomly divided into two groups: group 1 with 134 patients to receive intravenous iron sucrose and group 2 with 134 patients to receive oral ferrous sulfate tablets.Results: The intravenous iron sucrose is superior in terms of tolerability and correction of iron deficiency anemia during pregnancy.Conclusion: It yields a quicker rise in Hb and serum ferritin with no major side effects. In the difficult terrain of Himachal Pradesh, this makes IV iron sucrose a better option for anemic pregnant women who do not have easy access to health facilities resulting in a large number of them reaching hospitals with moderate to severe anemia at a later gestation.

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

“…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.…”

“…Blinding at patient level and provider level was not always feasible owing to different routes of administration. 17 studies did not mention about blinding or open-label in their studies 54 , 57 , 59 , 61 , 62 , 64 , 65 , 70 , 72 , 74 – 76 , 78 , 79 , 81 , 82 , 85 ; 13 studies were open-label trials 19 , 56 , 58 , 63 , 66 , 67 , 69 , 71 , 73 , 77 , 80 , 83 , 86 . Two studies reported blinding of data analysts or statisticians 60 , 68 .…”

“…Of the total 34 included studies, 17 studies provided data on maternal outcomes(n = 22,152) 24 , 32 , 34 , 39 , 42 , 48 – 51 , 88 – 93 . Bencaiova et al 51 and Khalafallah et al 50 had multiple arms, thus a total of 19 studies were pooled for meta-analysis.…”

“…Eight 18 , 54 , 55 , 60 , 63 , 71 , 73 , 83 and four studies 63 , 73 , 80 , 83 provided data on the women (n = 1813) who had undergone caesarean section(CS) and assisted/ instrumental delivery respectively. Utilizing random effects model, pooled odds ratio showed no significant difference in the likelihood of CS (OR 1.10; 95% CI [0.86; 1.42], I 2 = 0%; p = 0.93; Moderate quality evidence ) and assisted/instrumental delivery (OR 1.27 [95% CI [0.70–2.28], I 2 = 2%; p = 0.40; Moderate quality evidence ) in women receiving IV as compared with those received oral iron.…”