Health Condition 1: D509- Iron deficiency anemia, unspecified Health Condition 2: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: IV Ferric Carboxy Maltose: For treatment of moderate to severe Iron deficiency anemia in pregnancy. Total iron requirement will be calculated using Ganzoni formula.
1000 mg (20 ml) dilu
Sponsors
Department of health research
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with iron deficiency anemia with hemoglobin levels between 5- 9.9gm/dl between 22-32 weeks of gestational age with following criteria Severe anemia with hemoglobin Moderate anemia with hemoglobin between 7-9.9 gms during 22-28 weeks not responding to oral iron given for 6 weeks Moderate anemia in last trimester irrespective of previous iron intake. Willing to sign an informed consent, deliver at the same site and willing for follow up
Exclusion criteria
Exclusion criteria: � Pregnant women with hemoglobin levels below 5gm/dl and above 9.9 gm/dl in the first or second trimester of pregnancy. � Pregnant women diagnosed with anemia other than iron deficiency anemia based on peripheral smear examination and red cell indices, picture suggestive of pancytopenia, � Any known cases of hemoglobinopathies or with Pregnancy Induced Hypertension � History of iron overload disorder (Thalassemia, hemochromatosis, hemosiderosis] � Pregnant women with known cardiac, renal, hepatic disease � Pregnant women having associated medical disorders like hypertension, asthma, tuberculosis, heart disease rheumatic or congenital heart disease), heart failure or cardiac decompensation, � history of intravenous iron therapy in the past 6 months or history of repeated blood transfusions � Pregnant women with known OR history of hypersensitivity to ferric carboxy-maltose or iron sucrose � Pregnant women in labor � Blood loss due to hemodynamic instability � History of malignancy, GI bleed, surgery � suspected acute infections (such as upper respiratory tract infections, urinary tract infections, or fever at the time of visit), h/o of rashes and fever during pregnancy to rule rubella)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Hb, Ferritin, transferrin saturation 2. Adverse events during IV iron administration 3. Compliance to treatment 4. Need for blood transfusions 5. Anemia in mother post-partum at 6 weeks 6. Type of delivery and indications 7. Complications during delivery ââ?¬â?? PPH, puerperal sepsis, shock etc 8. Live births, still births 9. Birth weight 10. Prolonged hospital stay 11. Need for admission in intensive care unit Timepoint: 1.4weeks 2.6months | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability Costs and Quality of lIfeTimepoint: baseline, during intervention, 4 weeks post intervention and 6 weeks post partum | — |
Countries
India
Contacts
Public ContactDr Beena Joshi
ICMR National institute for research in reproductive health
Outcome results
None listed