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Clinical Trials/CTRI/2024/10/074985
CTRI/2024/10/074985Not yet recruitingPhase 3

COMPARATIVE STUDY OF INTRAVENOUS FERRIC CARBOXY MALTOSE VERSUS INTRAVENOUS IRON SUCROSE FOR TREATMENT OF ANEMIA IN PREGNANCY

Dr Santosh B Nirwani1 site in 1 country100 target enrollmentStarted: October 22, 2024Last updated:

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

Sponsor
Dr Santosh B Nirwani
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DR SANTOSH B NIRWANI

KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI

Study Sites (1)

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