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CTRI Number  CTRI/2021/08/036037 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 25/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess if using IV Ferric Carboxy Maltose (FCM) in Management of Iron Deficiency Anemia (IDA) among pregnant women is better than IV Iron Sucrose in terms of duration of treatment, side effects and cost-effectiveness at sub district health system in Maharashtra  
Scientific Title of Study   Implementation research to explore operational feasibility, acceptability and cost-effectiveness of using IV Ferric Carboxy Maltose (FCM) in Management of Iron Deficiency Anemia (IDA) among pregnant women through sub district health system in Maharashtra 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Beena Joshi 
Designation  Scientist F, 
Affiliation  ICMR National institute for research in reproductive health 
Address  Department of Operational Research, Room No. 111 First Floor Jehangir Merwanji Street, Parel, Mumbai - 400 012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192043  
Fax    
Email  bjoshithane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Beena Joshi 
Designation  Scientist F, 
Affiliation  ICMR National institute for research in reproductive health 
Address  Department of Operational Research, Room No.111, First floor Jehangir Merwanji Street, Parel, Mumbai - 400 012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192043  
Fax    
Email  bjoshithane@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Beena Joshi 
Designation  Scientist F, 
Affiliation  ICMR National institute for research in reproductive health 
Address  Department of Operational Research, Room No:111, First Floor Jehangir Merwanji Street, Parel, Mumbai - 400 012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192043  
Fax    
Email  bjoshithane@gmail.com  
 
Source of Monetary or Material Support  
Department of Health Research Department of Health Research Ministry of Health and Family Welfare Indian Red Cross Society Building Red Cross Road, New Delhi-110001 
 
Primary Sponsor  
Name  Department of health research 
Address  2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat Mahale  Patangshah Cottage Hospital Jawhar  Department of OBGYN Cottage Room No 17 Cottage Hospital Jawhar,401603 Palghar
Thane
MAHARASHTRA 		 09321216311

drbharatmahale@gmail.com 
Dr Nita Gangurde  Sub district Hospital Dahanu  Department of OBGYN R. No. 16 Subdistrict Hospital Dahanu 401601
Thane
MAHARASHTRA 		 0967350475

nitagangurde94@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIRRH ETHICS COMMITTE FOR CLINICAL STUDIESE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (2) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IV Ferric Carboxy Maltose  For treatment of moderate to severe Iron deficiency anemia in pregnancy. Total iron requirement will be calculated using Ganzoni formula. 1000 mg (20 ml) diluted in 250 ml sterile 0.9% normal saline will given over a period of 15 minutes. Followup after one month and if anemia persists dose will be repeated.  
Comparator Agent  IV Iron Sucrose  This arm will be as per the standard of care for treatment of moderate to severe Iron deficiency anemia in pregnancy. Total iron requirement will be calculated using Ganzoni formula.Iron Sucrose 200 mg of elemental iron diluted in 200 ml of normal saline 0.9% will be given as slow IV infusion over a period of 30 minutes in this study and repeated on alternate days until the required dose is administered. Followup after one month and if anemia persists dose will be repeated.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Diagnosed with iron deficiency anemia with hemoglobin levels between 5- 9.9gm/dl between 22-32 weeks of gestational age with following criteria
Severe anemia with hemoglobin <7 gms anytime between 22-32 weeks
Moderate anemia with hemoglobin between 7-9.9 gms during 22-28 weeks not responding to oral iron given for 6 weeks
Moderate anemia in last trimester irrespective of previous iron intake.
Willing to sign an informed consent, deliver at the same site and willing for follow up
 
 
ExclusionCriteria 
Details  • Pregnant women with hemoglobin levels below 5gm/dl and above 9.9 gm/dl in the first or second trimester of pregnancy.
• Pregnant women diagnosed with anemia other than iron deficiency anemia based on peripheral smear examination and red cell indices, picture suggestive of pancytopenia,
• Any known cases of hemoglobinopathies or with Pregnancy Induced Hypertension
• History of iron overload disorder (Thalassemia, hemochromatosis, hemosiderosis]
• Pregnant women with known cardiac, renal, hepatic disease
• Pregnant women having associated medical disorders like hypertension, asthma, tuberculosis, heart disease rheumatic or congenital heart disease), heart failure or cardiac decompensation,
• history of intravenous iron therapy in the past 6 months or history of repeated blood transfusions
• Pregnant women with known OR history of hypersensitivity to ferric carboxy-maltose or iron sucrose
• Pregnant women in labor
• Blood loss due to hemodynamic instability
• History of malignancy, GI bleed, surgery
• suspected acute infections (such as upper respiratory tract infections, urinary tract infections, or fever at the time of visit), h/o of rashes and fever during pregnancy to rule rubella)
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Change in Hb, Ferritin, transferrin saturation
2. Adverse events during IV iron administration
3. Compliance to treatment
4. Need for blood transfusions
5. Anemia in mother post-partum at 6 weeks
6. Type of delivery and indications
7. Complications during delivery – PPH, puerperal sepsis, shock etc
8. Live births, still births
9. Birth weight
10. Prolonged hospital stay
11. Need for admission in intensive care unit
 		 1.4weeks 2.6months 
 
Secondary Outcome  
Outcome  TimePoints 
Feasibility and acceptability
Costs and Quality of lIfe 		 baseline, during intervention, 4 weeks post intervention and 6 weeks post partum 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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   N/A 
Date of First Enrollment (India)   03/09/2021 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study is focusing on a very important public health problem “Anemia in Pregnancy”. Very recently IV Sucrose was tested for its efficacy among anemic pregnant women1 which showed no difference in pregnancy outcomes due to use of injectable vs oral iron. Till date IV Iron sucrose is the most commonly used injectable iron preparation for treatment of iron deficiency anemia. However use of this iron sucrose mandates the patient to visit the health facility three times on alternate day .This study intends to test the new compound Ferric Carboxy Maltose (FCM) for managing anemia in pregnancy which is given in a bolus single dose and equally efficacious with no adverse  effects . A single dose of FCM may have better compliance than multiple doses with IV Iron Sucrose. Although Poshan Abhiyan has suggested this drug in the guidelines, State health department of Maharashtra has not officially introduced it in program at all levels of health care. Hence this study will generate evidence to facilitate program decision making and strengthen the management strategy within district health system.

a]Pregnant women registered for ANC & diagnosed with moderate IDA between 22weeks-32 weeks [after trying standard oral iron] OR diagnosed with severe anemia between 22 weeks to 32 weeks of pregnancy]

b]Not responding to oral iron therapy  

c]Enroll for parenteral iron randomly assigned to either IV  FCM or IV   Iron sucrose  

d]Follow up after 4 weeks to check improvement in blood indices

e]Follow-up 6 weeks after delivery to document pregnancy and neonatal

                     

 
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