Inj. Ferric Carboxymaltose (FCM) Vs Iron Isomaltoside (IIM) in treatment of iron deficiency anemia in Pregnancy (Antenatal)

Completed

• Conditions: Other maternal disorders predominantly related to pregnancy,

• Registration Number: CTRI/2020/05/025180
• Lead Sponsor: Bhawna Garg

Brief Summary

This study is a hospital based study which aims at comparing the efficacy of two parenteral iron preparations used in correction of iron deficiency anemia in pregnancy. Antenatal patients whose hemoglobin is in range of 7 to 10.9 g/dl will be screened in Antenatal Out patient department and will be screened for participation in the study. After the informed consent is taken, randomization will be done by SNOSE method. After randomisation, participants will be distinguished in two arms - Injection Iron isomaltoside and Injection Ferric Carboxymaltose. Iron deficit will be calculated by Ganzoni’s formula and accordingly iron correction will be done. 500 mg of Iron isomaltoside will be given in 100ml normal saline over 6 minutes and 500 mg of Ferric Carboxymaltose will be given in 250 ml Normal saline over 10 minutes. Drug administration will be done in ward where facilities of cardiopulmonary resuscitation are present. Vitals and fatal heart rate will be monitored prior to administration, during the administration and after the administration of drugs. Immediate side effects will be noted and patient will be observed for 30 minutes after the drug is administered for systemic and local side effects. Patient will be called up for follow up at 26-30 weeks of gestation

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Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-14
• Study Completion: 2022-04-20
• Last Update Posted: 2022-07-24

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

Antepartum women whose Hemoglobin is in range of 7 to 10.9 gram per decilitre Women in second trimester of pregnancy (14- to 22 weeks).

Exclusion Criteria

• Women not willing to participate Women with less than 14 weeks of gestation Women in labor Known case of Thalassemia or Megaloblastic anemia Women who have a history or known allergy to parenteral iron infusion.
• Women with normal serum ferritin levels history of any liver disease history of any Autoimmune disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy (rise in Haemoglobin) of Injection Iron Isomaltoside in comparison to Injection Ferric Carboxymaltose in treating Iron deficiency anemia in pregnancy.	at 26 to 30 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
To investigate the safety in terms of local and systemic reactions and tolerability of injection Iron Isomaltoside in comparison with injection Ferric CarboxyMaltose	immediately during drug administration till the period of 30 minutes

Trial Locations

Locations (1)

KLEs Dr Prabhakar Kore Hospital; 🇮🇳 Belgaum, KARNATAKA, India

KLEs Dr Prabhakar Kore Hospital

🇮🇳Belgaum, KARNATAKA, India

Bhawna Garg

Principal investigator

8496017030

gargbhawna93@yahoo.com