Treatment of Iron Deficiency Anemia in Pregnancy Clinical Trial
Official title:
Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment