Health Condition 1: null- Pregnant women with anemia( Hb between 5-9 gm%)
Conditions
Interventions
Intervention1: Intravenous Iron Sucrose: Iron sucrose complex will be administered as 200mg elemental iron in 100ml 0.9%NaCl infusion for a period not more than 1 hr every 3 days until total required
Sponsors
Indian Institute of Public Health
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: Pregnant women • Consenting women aged above 18 years • With Hb between 5-8 gm/dl between 20- 28 weeks of gestation • With Hb between 5-9 gm/dl between >28- 32 weeks of gestation • MCV/RBC ratio above 14% • Plans to deliver in same health care facility and be available for a visit 6 weeks post delivery • Resides within 20 km radius from the recruiting hospital Exclusion criteria • Hb > 9gms/dl and • Pancytopenia • High suspicion of haemoglobinopathies based on clinical history and previous history of blood transfusion • Medical complications like hypertension, diabetes, asthma, hepatitis • Suspected acute infections like ARTI, UTI • K/C/O Heart disease like RHD, CHD and Heart Failure • H/o of previous parenteral iron therapy within 6 months • H/o intolerance of IV iron
Exclusion criteria
Exclusion criteria: � Hb > 9gms/dl and � Pancytopenia � High suspicion of hemoglobinopathies based on clinical history and previous history of blood transfusion � Medical complications like hypertension, diabetes, asthma, hepatitis � Suspected acute infections � H/o of previous parentral iron therapy within 6 months � H/o intolerance of IV iron
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of potentially life threatening conditions which includes need for blood transfusion, post-partum haemorrhage, puerperal sepsis, shock, prolonged hospital stay (7 day postpartum stay) any ICU admission or referral to higher centresTimepoint: 6 weeks post partum | — |
Secondary
| Measure | Time frame |
|---|---|
| Components of the primary maternal composite end pointTimepoint: 6 weeks post partum;Components of the secondary fetal endpointsTimepoint: 6 weeks post partum;Composite of perinatal death, preterm labour and low birth weight (fetal composite endpoint)Timepoint: 6 weeks post partum;Economic outcomes Cost per maternal death averted avertedTimepoint: 6 weeks post partum;Haemoglobin and MCVTimepoint: 6 wks from randomization at delivery and 6 weeks post delivery;Immediate and late adverse events Timepoint: during administration and 6 weeks post randomization;Iron stores (serum ferritin)Timepoint: At delivery and 6 weeks post delivery;Quality of life of motherTimepoint: 6 weeks from randomization and 6 weeks post delivery | — |
Countries
India
Contacts
Public ContactDr Sutapa B Neogi
Indian Institute of Public Health- Delhi
Outcome results
None listed