Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Global Rainbow Healthcare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women ready to give informed consent for participation in study. 2. Pregnant women more than 18 years of age visiting to department of Obstetrics and Gynecology of gestational age between 16-36 weeks. 3. Pregnant women with hemoglobin (Hb) level more than 6 and less than 10 g/dl. 4. Pregnant women with serum ferritin level less than 50 �µg/L 5. Pregnant women with poor compliance to oral iron or oral iron therapy not tolerable or oral iron therapy is inappropriate based on clinical judgment of investigator.
Exclusion criteria
Exclusion criteria: 1. Any other type of anemia other than iron deficiency anemia 2. Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis). 3. Prior history of allergic reaction to IV iron 4. Significant cardiovascular disease (including myocardial infarction during the 6 months prior to study inclusion, congestive heart failure NYHA Class III or IV and poorly controlled hypertension) 5. Uncontrolled endocrinological or metabolic disorders including uncontrolled hyperparathyroidism. 6. Presence of any active infection 7. Known case of malignancy 8. Presence of active liver disease / HBV or HCV infection, HIV infection / AIDS, asthma, or rheumatoid arthritis 9. Treatment with IV Iron preparations or any investigational drug within 4 weeks prior to study enrollment 10. Any condition that, in the opinion of the investigator, does not justify the patientââ?¬•s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin (g/dL)Timepoint: At baseline, 4 weeks and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum ferritin levels. Change in hematological parameters (PCV, MCV, MCH, MCHC). Fatigue measurement by Linear Analogue Scale Assessment. Health-related quality of life outcomes measured with the Short Form-36 Health Survey (SF-36). Adverse effects during the study Timepoint: Change in serum ferritin levels over 6 weeks. Change in hematological parameters (PCV, MCV, MCH, MCHC) over 6 weeks. Fatigue measurement by Linear Analogue Scale Assessment at week 2, 4 & 6. Health-related quality of life outcomes measured with the Short Form-36 Health Survey (SF-36)at week 2, 4 & 6. Adverse effects during the study | — |
Countries
India
Contacts
Public ContactDr Narendra Malhotra
Global Rainbow Healthcare
Outcome results
None listed