Efficacy and Safety Study Tablet ( Irpo- FA®) in Pregnant Wome
Phase 4
- Conditions
- Iron Deficiency & Folic acid Deficiency anemia.Iron deficiency anaemia, unspecified & Folate deficiency anaemia, unspecifiedD-50 & D-5
- Registration Number
- IRCT201610197978N3
- Lead Sponsor
- abiqasim Industries (Pvt) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Inclusion Criteria: Pregnant Women in second or third trimester or after 12 weeks of pregnancy, Hb: = 10. 5g/dl after first trimester and serum ferritin levels are below than normal (less than 35 µg/l)
Exclusion Criteria
Patient with a history of non-compliance with iron therapy or allergic to iron preparation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase of 1g/dl Hb with 100-200mg/day elemental iron. Timepoint: 2 weeks, 1 month, 2 months and three months after initiation of oral iron therapy. Method of measurement: C. B. C, Ferritin, iron profile tests.
- Secondary Outcome Measures
Name Time Method Gastrointestinal adverse events. Timepoint: At every visit and Follow up checkups. Method of measurement: Patient monitoring & Follow up calls to patients.