Health Condition 1: null- Pregnant anaemic women
Conditions
Interventions
Intervention1: Intravenous ferric carboxymaltose: Patient will receive IV FCM. Maximal dose in a single day will be 15mg/kg, not to exceed 1000mg. 1000mg of FCM will be diluted in 200ml normal saline
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1)Pregnant women with period of gestation 16-36weeks 2)Iron deficiency anemia with serum Hb >6g/dl and 3)Not tolerating oral iron 4)Non-compliant to oral iron therapy 5)Willing to participate and follow up
Exclusion criteria
Exclusion criteria: 1)Age less than 18 years 2)Anemia due to causes other than iron deficiency anemia 3)Co existing disorders of erythropoiesis or hemochromatosis 4)Chronic infections like hepatitis and HIV 5)Serum transaminase level > 1.5 times the upper limit of normal 6)Serum creatinine level > 2.0mg/dl 7)Patients with history of allergic reaction to intravenous iron infusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Change in Hb level from baselineTimepoint: 0,3,6,12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change in ferritin levels 2)Number of women achieving normalisation of Hb (â?¥11g/dL) 3)Change in serum iron and RBC indices 4)Normalisation of RDW 5)Change in fatigue levels 6)Change in well-being score 7)Safety and side effects of treatment 8)Obstetrical outcome Timepoint: 0,3,6,12 weeks | — |
Countries
India
Contacts
Public ContactDr Ambily Jose
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed