A clinical trial to compare oral iron ferrous sulfate with newer intravenous iron (ferric carboxymaltose) injection in patients of iron deficiency anemia in post delivery period
Phase 4
Completed
- Conditions
- Health Condition 1: null- Iron deficiency anemia
- Registration Number
- CTRI/2014/10/005099
- Lead Sponsor
- CMS and GTB Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
1.Postnatal women within 10 days of normal delivery.
2.Hb should be more than or equal to 7 gm% and less than or equal 10 gm%.
3.Peripheral smear showing microcytic hypochromic anemia or red cell indices suggestive of iron deficiency anemia (PCV <36%, MCV <80fl, MCH <27pg and MCHC <33gm/dl) with negative NESTROF test.
Exclusion Criteria
1.Women with weight <35 kg.
2.Puerperal pyrexia.
3.Known drug allergy or intolerance to iron therapy.
4.History of chronic medical illness such as tuberculosis, asthma, liver diseases, kidney diseases, diabetes mellitus, hypertension, HIV infection.
5.Received other intervention for management of anemia such as blood transfusion, erythropoietin administration in last three months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients achieving Hb rise 3 g/dl from baseline at 3 and 6 weeks.Timepoint: Percentage of patients achieving Hb rise 3 g/dl from baseline at 3 and 6 weeks.
- Secondary Outcome Measures
Name Time Method - Percentage of patients achieving Hb 12 g/dl at 3 and 6 weeks. <br/ ><br>- Rise in Hb from baseline to 3 and 6 weeks. <br/ ><br>- Change in red cell indices and serum iron parameters from baseline to 6 weeks. <br/ ><br>- Recording the side effects in both the groups such as dysguesia, nausea, abdominal pain, urticaria, muscle cramps, headache, nasopharyngitis, fever, infusion site burning pain, serum transaminase elevation, etc.Timepoint: 6 weeks