A clinical trial to study efficacy of a injectable iron preparation (FCM) as compared to oral iron in the treatment of iron deficiency anemia in 3rd trimester of pregnancy.
Phase 3
- Conditions
- Health Condition 1: null- Antenatal cases between 28 weeks to 36 weeks POG reporting to OPD and admitted to ANC ward
- Registration Number
- CTRI/2017/06/008884
- Lead Sponsor
- Armed Forces Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 173
Inclusion Criteria
Antenatal cases detected to have Haemoglobin >7.5 gm% and <11 gm% between 28 to 36 weeks POG reporting to ANC clinic and admitted in ANC ward
Exclusion Criteria
Anemia due to other than iron deficiency
History of blood transfusion
Treatment with any bone marrow suppressive therapy
Erythropoietin within 3 months prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in Haemoglobin level to more than 11 gm%.Timepoint: Hb level gm % every 2 weeks till 37 weeks POG <br/ ><br>Final outcome to be assessed at 37 weeks POG
- Secondary Outcome Measures
Name Time Method Safety and tolerability, quality of life and newborn statusTimepoint: Safety and tolerability, quality of life to be assessed every 2 weeks. <br/ ><br>New born status in postnatal period.