EFFECT OF ADDING RECOMBINANT ERYTHROPOIETIN TO IRON SUCROSE IN TREATMENT OF SEVERE ANEMIA IN SECOND HALF OF PREGNANCY: A RANDOMIZED CLINICAL TRIAL Amr Sharafeldeen Department of Obstetrics and Gynecology, Faculty of Medicine, Benha University, Egypt
Objective: The aim of this trial was to evaluate the effectiveness and safety of intravenous infusion (IV) of iron sucrose (IS) with adjuvant recombinant human erythropoietin (rhEpo) versus Intravenous Iron sucrose alone in treating severe iron deficiency anemia (IDA) in second half of pregnancy. Patients and Methods: Seventy two pregnant women with gestational age ³ 20 week with severe IDA resistant to oral iron treatment were randomly allocated to IS+ group, where women received 200 mg iron sucrose intravenously in 50 ml 0.9% saline directly three times per week and after 1st week rhEpo subcutaneously was added at each iron treat visit at 4000 u dose and to IS – group, when women only received intravenous iron sucrose in the some prior fashion, the target hemoglobin was 11 gm /dl. The main outcomes were hematological respond to treatment as increase in hemoglobin (Hg), Hematocrite % (hct) and reticulocytic count% (RC) while the secondary outcomes were other hematological response parameters, serum ferritin, patients anemia related symptoms, side effects of treatment. Results: Both treatment regimens were safe and effective in treating severe gestational IDA but the change in hematological parameters at follow up period 8, 15, 22, 43 day were significantly in favor adding rhEpo to IS including reticelocytic count (P < 0.05), hemoglobin (P < 0.05), rising of hematocrit % (P < 0.05). Also the improvement of anemia related symptoms with in favor of adding rhEpo to IS at 8, 15, 43 day P < 0.05). At the end of the trial (day 43) more women in IS+ group reach target HB of 11 mg/dl, the women didn't reach target HB of 11gm/dl were (2/30 (6.6%) in IS+ versus 8/29 (27.5%) in IS-, P = 0.02). There was no difference as regards serum ferritin as well as maternal and fetal safety outcomes parameters. Conclusion: Intravenous iron sucrose 200 mg in 50 ml 0.9% saline given intravenous day after day with adding subcutaneous recombinant women erythropoietin (4000 u) in the second week after replenish the iron stores safely synergistic the efficacy of the iron sucrose regimen in correcting severe iron deficiency anemia in second half of pregnancy which failed to be treated with oral iron.