A Randomised Controlled Trial to Compare Intravenous Iron Sucrose and Oral Iron in Treatment of Iron Deficiency Anemia in Pregnancy

Abstract

The aim of this study was to compare the efficacy and safety of intravenous iron sucrose with oral iron therapy in pregnant patients with anemia. The primary outcome of the study was increase in haemoglobin on day 7, 14 & 28 and rise of serum ferritin over 28 days. The study population consisted of 100 patients with singleton pregnancy between 24 and 34 weeks, hemoglobin levels between 7.0-9.0 gm/dL and serum ferritin levels less than 15 ng/mL. The participants in the oral group were given daily 180 mg elemental iron in three divided oral doses for 4 weeks. Total calculated dose of iron sucrose with a target hemoglobin of 11 gm %, was given in 200 mg dose on alternate days. Mean haemoglobin rise was 0.58 gm/dL in the IV group as compared to 0.23 gm/dL in the oral group on day 14 and 1.9 gm/dL in the IV group & 1.3 gm/dL in the oral group on day 28, (p <0.05). In the IV group, 76% of the subjects achieved haemoglobin levels of ≥11 gm% at the time of delivery, as compared to only 54% of the subjects in the oral group who achieved these levels. Serum ferritin value was significantly higher in the IV group, 37.45 ± 5.73 ng/mL as compared to 13.96 ± 1.88 ng/mL in the oral group at 4th week (p <0.001). There was no major side effect in the IV group. 36% subjects in the oral group developed gastrointestinal side effects & 10% of the subjects were non compliant. The rate of hemoglobin rise is faster with intravenous iron sucrose therapy as compared to oral iron therapy which can be beneficial in pregnant women presenting with anemia at a later period of gestation. Intravenous iron sucrose is very well tolerated during pregnancy.

Safety and efficacy of intravenous iron polymaltose, iron sucrose and ferric carboxymaltose in pregnancy: A systematic review

“…The majority of studies involved a comparison group of some kind including oral iron (n = 17; 36%), 11,14,16,19,24,26,27,29,31,32,34,35,37,39,50,56,57 IV iron (n = 4; 9%), 13 [14][15][16]18,20,24,26,28,31,[33][34][35][36][37][38][39]41,42,44,49,50,53 Only one study was identified that directly compared the administration of a full replacement dose of IV iron to a dose that was 300 mg less than the calculated full replacement dose. In comparing the two groups, administration of the full replacement dose was associated with a greater increase of 8 g/L 3-4 weeks after administration and 14 g/L at delivery.…”

“…13 Among other comparative studies, none demonstrated any statistically significant differences between groups across any perinatal outcomes investigated, including birth weight, gestational age, method of delivery, and postpartum haemorrhage. 11,14,16,24,30,31,37,38,54,56 Notably, the small study samples included in each of these studies limited the statistical power to detect clinically relevant differences between the two groups.…”

“…11,13,16,20,[22][23][24][25]27,31,32,34,36,38,40,44,49 Across all studies, the median reported prevalence of ADRs was similar among prospective (4.5%) 11,16,19,20,22,23,27,29,31,32,34,36,38,40,44,49,53,[55][56][57] and retrospective (5%) 13,52,54 studies. Eighteen studies administered a test dose, 15,23,[25][26][27][28][29][30][31]34,37,…”

“…Compared to oral iron, use of IV iron was associated with a greater increase in haemoglobin at 2-4 weeks following the infusion (median: 6 g/L; range: 1-20 g/L) 11,16,26,27,29,31,34,35,37,39,50,56 and at delivery (median: 6.8 g/L; range: 6-19 g/L). 14,16,32,56 When examining ferritin at 4 weeks, seven of eight studies demonstrated a greater median increase of 38 μg/L (range: 25-222 μg/L) among the group receiving IV rather than oral therapy.…”

“…14,16,32,56 When examining ferritin at 4 weeks, seven of eight studies demonstrated a greater median increase of 38 μg/L (range: 25-222 μg/L) among the group receiving IV rather than oral therapy. 11,24,26,27,35,37,50,56 Only two studies reported on difference in ferritin at deliv- …”