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This study was planned to compare outcomes of IV versus oral iron in the treatment of iron deficiency anemia during pregnancy. This study was used to investigate the efficacy of two new formulations of iron both in IV and oral form with fewer side effects. We compared the efficacy of Intravenous Ferric Carboxymaltose with Oral polysaccharide iron complex. The better mode of treatment will be administered in future to treat this condition, that will surely improve the fetal and maternal outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A participants who were administered Intravenous Iron supplementation (Ferric carboxymaltose ) | Active Comparator | Treatment was initiated at the baseline visit. After baseline data was collected, women allocated to the IV iron group received a single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions were administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma. |
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| Group B participants who were administered Oral Iron Supplementation (polysaccharide iron complex) | Active Comparator | Women in the oral iron group received polysaccharide iron complex 150 mg capsule till 4 weeks. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Carboxymaltose | Drug | Single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions was administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Haemoglobin Levels | Non Anaemic Levels are labelled as (Hb ≥ 11.0 g/dL) at 4th week | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctors Hospital and Medical Centre Lahore | Lahore | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| C013276 | teferrol |
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| Iron Polymaltose Complex | Drug | Polysaccharide iron complex 150 mg capsule was administered daily till 4 weeks |
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