Fernández MJR, Silva LN, Roque DT, Aznar GE

Language: Spanish
References: 0
Page: 260-271
PDF size: 463.71 Kb.

ABSTRACT

Rationale: Anemia is the most frequent among the diseases concurring with pregnancy, or be caused by it; and carries a heavy burden of mother and neonatal morbidity. Objectives: To assess the usefulness and safety of an organic iron preparation in the prevention of anemia in pregnant women. Study location: “10 de Octubre” Mother-Child Teaching Hospital (Havana City, Cuba). Experimental design: Phase III controlled clinical trial. Study serie: One-hundred sixty-four pregnant women with serum Hemoglobin (Hb) ≥ 110 g.L^-1 at the onset of pregnancy. Methods: Pregnant women were included in this trial from the very diagnosis of pregnancy (made before the 14 weeks of gestation). Pregnant women were (seudo)randomly assigned to either of two groups: Control Group: Eighty-five women (Hb: 110.6 ± 1.1 g.L^-1): Treatment with Prenatal^{© ®}(Elemental iron: 100 mg/tablet): 2 tablets/day vs. Treatment Group: Seventy-nine women (Hb: 110.3 ± 0.8 g.L-1; p > 0.05): Treatment with Combifer^{© ®} (Heminic iron: 15 mg + Iron from other sources: 50 mg): 2 tablets/day. The trial was prolonged from the moment of diagnosis up to discharge on postpartum. Effectiveness of Combifer^{© ®} (Centro Nacional de Biopreparados, Bejucal, Mayabeque, Cuba) was measured from Hb values on 28 – 30 weeks of gestation, antepartum, and on postpartum discharge. Results: No interruptions in the treatment with either of the antianemics were reported during the conduction of this trial. Treatment with Combifer^{© ®} resulted in higher Hb values: 28 – 30 weeks: 115.8 ± 1.4 g.L^-1 ( = +8.8 g.L^-1; p < 0.05); Antepartum: 114.1 ± 1.8 g.L^-1 ( = +10.3 g.L^-1; p < 0.05); and Discharge (postpartum): 110.9 ± 2.2 g.L^-1 ( = +11.0 g.L-1; p < 0.05); respectively; and a higher rate of Hb ≥ 110 g.L^-1: 28 – 30 weeks: 74.1%; ( = +53.8%; p < 0.05); Antepartum: 73.4% ( = +56.9%; p < 0.05): and on Discharge (pospartum): 58.2% ( = +46.4%; p < 0.05). Frequency of adverse events after use of Combifer^{© ®} was lower (p < 0.05). Conclusions: The organic iron preparation might be effective for preventing anemia during pregnancy and early postpartum.