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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
Exclusion criteris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theragran Hematinic, oral iron, 120 mg elemental iron/ | Active Comparator | pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® SmithKline Beecham, Egypt an affiliated co. to GlaxoSmithKline. Adherence to the treatment will be monitored by asking the women to bring back the empty packs and mark the consumption of tablets on calendar. |
|
| low molecular weight iron dextran, total dose infusion | Active Comparator | 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). Patients selected for parental iron will be admitted as day cases in the hospital in a single visit. The required dose has to 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theragran Hematinic | Drug |
| ||
| low molecular weight iron dextran |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who have been successfully treated | The proportion of patients who have been successfully treated as evidenced by a hemoglobin concentration of > 10.5 g% after 8 weeks from completing treatment (oral or total iron dose infusion therapy). | up to 8 weeks from comleting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse effects | up to 8 weeks after completing treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed S. Sweed, MD | AinShams University | Principal Investigator |
| Hazem M. Sammour, Professor | AinShams University | Study Director |
| Abdel-Latif G. El-Kholy, Ass. Prof. | AinShams University | Principal Investigator |
| Eman M. El-Garhi, M.B.B.Ch. | El Galaa Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity Hospital, Faculty of Madicine, AinShams University | Cairo | Egypt |
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| Drug |
|
|
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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