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CTRI Number  CTRI/2024/10/074985 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized Control Study: Comparison of Two Iron preparations for Anemia in Pregnant Women: Ferric Carboxymaltose vs. Iron Sucrose 
Scientific Title of Study   COMPARATIVE STUDY OF INTRAVENOUS FERRIC CARBOXY MALTOSE VERSUS INTRAVENOUS IRON SUCROSE FOR TREATMENT OF ANEMIA IN PREGNANCY  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SANTOSH B NIRWANI 
Designation  POSTGRADUATE STUDENT  
Affiliation  KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI 
Address  POSTGRADUATE STUDENT DEPARTMENT OF OBG KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI

Dharwad
KARNATAKA
580021
India 
Phone  9743960876  
Fax    
Email  santosh.nirwani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR S V NACHIKETHA  
Designation  PROFESSOR  
Affiliation  KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI 
Address  DEPARTMENT OF OBG KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI

Dharwad
KARNATAKA
580021
India 
Phone  9343882242  
Fax    
Email  svn1974@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SANTOSH B NIRWANI 
Designation  Post Graduate Student 
Affiliation  KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI 
Address  DR SANTOSH B NIRWANI DEPARTMENT OF OBG KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI

Dharwad
KARNATAKA
580021
India 
Phone  9743960876  
Fax    
Email  santosh.nirwani@gmail.com  
 
Source of Monetary or Material Support  
Department of OBG Karnataka Medical College and Research Institute Vidyanagar Hubballi-580021 dist Dharwad state Karnataka- India 
 
Primary Sponsor  
Name  Dr Santosh B Nirwani  
Address  Dr Santosh B Nirwani Postgraduate Student Department of OBG Karnataka Medical College and Research Institute Vidyanagar Hubballi Dharwad Karnataka 580021 India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SANTOSH B NIRWANI  Karnataka Medical College and Research Institute Hubballi  Antenatal ward room no 805 and OPD room no 7 Department of OBG Karnataka Medical College and Research Institute Hubballi
Dharwad
KARNATAKA 		 9743960876

santosh.nirwani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnataka Institute of Medical Sciences Hubballi Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administration of 1gm of Ferric Carboxy maltose  Single dose Intravenous administration of 1gm of Ferric Carboxy maltose in 250ml Normal saline over 20 minutes 
Comparator Agent  Administration of Iron sucrose   Five doses of Intravenous administration of 200mg Iron Sucrose in 100ml Normal saline over 20 minutes on alternate days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  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.
 
 
ExclusionCriteria 
Details  1.Pregnancy more than 32 weeks of gestation.
2.K/C/O thalassemia& sickle cell anemia.
3.H/O allergic reactions to iron preparations.
4. History of blood transfusion in last 3months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study and compare the difference in rise in hemoglobin on administration of IV ferric carboxymaltose and IV iron sucrose.  To Compare the efficacy of IV Ferric Carboxymaltose and IV Iron Sucrose after 4 weeks of last dose 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   22/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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