Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Condition: Treatment of Iron Deficiency Anemia in Pregnancy
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the effect of iron supplementation using oral routes in comparison with total dose
      infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.
    

Detailed description: 
      Patients will be allocated to two groups of 106 each and to insure that everyone has the
      chance of participation, randomization will be guided by table of random numbers All women
      recruited in the study will be given 100 mg mebendazole tablets twice daily for 3 days for
      de-worming and 500 micro gram folic acid daily till the end of the study The required dose
      will be individually adapted according to the total iron deficit which is dependent on the
      patient's body weight and hemoglobin status Total iron dose (mg) = weight (kg) X hemoglobin
      deficit {target hemoglobin (g/l)- Actual hemoglobin (g/l)} X 0.24 + 500 mg The total iron
      dose needed will be calculated by formula rounded to nearest multiple of 100 Group I includes
      pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets
      (Theragran Hematinic)® Smith-Kline Beecham, Egypt an affiliated co. to Glaxo Smith-Kline,
      according to the WHO guidelines for IDA control Group II includes pregnant women taking
      elemental iron in the form of low molecular weight dextran complex intravenously as a total
      dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R Pharmacosmos Denmark (Inspire
      Pharma Egypt) Inclusion criteria

        -  Maternal age 20-35 years old.

        -  Singleton pregnancy between 16 - 24 weeks

        -  Iron deficiency anemia with average hemoglobin ranging from 7-9 g/dL at the onset of the
           study

      Exclusion criteris

        -  Extremes of reproductive age (less than 20 years old or more than 35 years old).

        -  Patients with multiple pregnancies.

        -  Anemia not linked to iron deficiency.

        -  Allergy to iron derivatives.

        -  Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis,
           cardiovascular disease, renal disease, autoimmune disease, suspected acute infection,
           cancer.

        -  Those who had received parenteral iron treatment earlier within 3 months before the
           start of the study.

        -  Any obstetric complicating factors like pregnancy induced hypertension (PIH).

        -  Patients with history of chronic blood loss.
    

Intervention name(s): Theragran Hematinic; low molecular weight iron dextran
Intervention type(s): Drug; Drug
Other intervention name(s): Cosmofer
Intervention MeSH terms: Dextrans; Iron-Dextran Complex; Hematinics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron deficiency anemia; Pregnancy; Iron therapy