COMPARATIVE STUDY OF INTRAVENOUS FERRIC CARBOXY MALTOSE VERSUS INTRAVENOUS IRON SUCROSE FOR TREATMENT OF ANEMIA IN PREGNANCY
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To study and compare the difference in rise in hemoglobin on administration of IV ferric carboxymaltose and IV iron sucrose.
Study Overview
Brief Summary
Maternal Complete hemogram and Serum ferritin sampling were done under aseptic precautions, peripheral veni-puncture blood samples were collected from the pregnant subjects for the determination of Hb levels before and after administration of the drugs.
The pregnant women were randomized into 2 groups, one receiving 1g of Inj ferric carboxymaltose and the other group receiving Inj iron sucrose 200mg 5 doses. Inj B12(2500 mcg) with folic acid(0.7 mg) was received by both the groups to remove B12 and folic acid deficiency as a confounding factor.
It takes three weeks for the rise of hemoglobin after administration of IV iron preparations. Hence hemoglobin was repeated after 3-4 weeks of administration of respective drugs and results were compared.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Patients diagnosed with mild to moderate anemia.
- •2.Antenatal patients with a period of gestation 16- 32 weeks of gestation.
- •3.Patients with Iron deficiency anemia.
Exclusion Criteria
- •1.Pregnancy more than 32 weeks of gestation.
- •2.K/C/O thalassemia& sickle cell anemia.
- •3.H/O allergic reactions to iron preparations.
- •History of blood transfusion in last 3months.
Outcomes
Primary Outcomes
To study and compare the difference in rise in hemoglobin on administration of IV ferric carboxymaltose and IV iron sucrose.
Time Frame: To Compare the efficacy of IV Ferric Carboxymaltose and IV Iron Sucrose after 4 weeks of last dose
Secondary Outcomes
- To Compare the secondary response of IV Ferric Carboxymaltose & IV Iron Sucrose(To compare secondary response to IV Ferric Carboxymaltose & IV Iron Sucrose after 30 minutes of administration)
Investigators
DR SANTOSH B NIRWANI
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI