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CTRI Number  CTRI/2021/01/030515 [Registered on: 18/01/2021] Trial Registered Prospectively
Last Modified On: 04/05/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Open Label 
Study Design  Single Arm Study 
Public Title of Study   A study of Ferric Carboxymaltose in Pregnant women lacking iron. 
Scientific Title of Study   Efficacy and Safety of Ferric Carboxymaltose Injection in Iron deficiency anemia in Pregnancy: A Prospective Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Gupta 
Designation  Director and Senior Consultant 
Affiliation  Pushpam Maternity Hospital and Sonography Centre 
Address  Pushpam Maternity Hospital and Sonography Centre. 33/34, Shantiniketan Common Centre, Sabarmati City: Ahmedabad

Ahmadabad
GUJARAT
380005
India 
Phone  9426499922  
Fax    
Email  pushpamgynec@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Gupta 
Designation  Director and Senior Consultant 
Affiliation  Pushpam Maternity Hospital and Sonography Centre 
Address  Pushpam Maternity Hospital and Sonography Centre. 33/34, Shantiniketan Common Centre, Sabarmati City: Ahmedabad

Ahmadabad
GUJARAT
380005
India 
Phone  9426499922  
Fax    
Email  pushpamgynec@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Usha Gupta 
Designation  Associate Doctor 
Affiliation  Pushpam Maternity Hospital and Sonography Centre 
Address  Pushpam Maternity Hospital and Sonography Centre. 33/34, Shantiniketan Common Centre, Sabarmati City: Ahmedabad

Ahmadabad
GUJARAT
380005
India 
Phone  9825091092  
Fax    
Email  m99922g@yahoo.com  
 
Source of Monetary or Material Support  
Pushpam Maternity Hospital Sonography Centre, 33/34, Shantiniketan Common Centre, Sabarmati, Ahmedabad 
 
Primary Sponsor  
Name  Pushpam Maternity Hospital Sonography Centre 
Address  33/34, Shantiniketan Common Centre, Sabarmati, Ahmedabad 
Type of Sponsor  Private hospital/clinic 
 
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 Mahesh Gupta   Pushpam Maternity Hospital and Sonography Centre  Pushpam Maternity Hospital and Sonography Centre, 33/34, Shantiniketan Common Centre, IOC Road, D Cabin, Sabarmati City: Ahmedabad
Ahmadabad
GUJARAT 		 9426499922

pushpamgynec@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rudraksha Hospital Ethics Committee, Rudraksha Hospital, first floor, Rajmandir Complex, B/S Dilbahar Restaurant, Off fly over Bareja, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O20-O29||Other maternal disorders predominantly related to pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Ferric carboxymaltose  Adequate cumulative dose must be calculated for each patient individually according to the iron deficit calculated by Ganzonis formula. Injection Ferric Carboxymaltose is a parenteral iron formulation given to correct iron deficiency anemia. It is given intravenously and can be given up to 1000mg in a single setting. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Pregnant women more than 18 years of age visiting to department of Obstetrics and Gynecology of gestational age between 16-36 weeks.
2. Pregnant women with hemoglobin (Hb) level more than 6 and less than 10 g/dl.
3. Pregnant women not responding to oral Iron or oral iron therapy not tolerable or oral iron therapy is inappropriate based on clinical judgment of investigator
4. Pregnant women ready to give informed consent for participation in study. 
 
ExclusionCriteria 
Details  1. Any other type of anemia other than Iron Deficiency anemia
2. Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis).
3. Prior history of allergic reaction to IV iron
4. Significant cardiovascular disease (including myocardial infarction during the 6 months prior to study inclusion, congestive heart failure NYHA Class III or IV and poorly controlled hypertension)
5. Uncontrolled endocrinological or metabolic disorders including uncontrolled
hyperparathyroidism.
6. Presence of any active infection
7. Known case of malignancy
8. Presence of active liver disease / HBV or HCV infection, HIV infection / AIDS, asthma, or rheumatoid arthritis
9. Treatment with IV Iron preparations or any investigational drug within 4 weeks prior to study enrollment
10. Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of ferric carboxymaltose (FCM) injection in moderate to severe iron deficiency anemia in pregnancy.  Mean change in hemoglobin from baseline to week 6. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the safety of ferric carboxymaltose (FCM) injection in moderate to severe iron deficiency anemia in pregnancy.
2. To assess improvement in fatigue. 		 1. Change in serum ferritin levels over 6 week.
2. Change in hematological parameters (PCV, MCV, MCH, MCHC) over 6 week.
3. Fatigue measurement by Linear Analogue Scale Assessment at week 2, 4 & 6.
4. Adverse effects during the study 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/01/2021 
Date of Study Completion (India) 11/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 11/01/2022 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a prospective, non-interventional, post-marketing, observational, investigator initiated study with involvement of pregnant women with iron deficiency anemia and clinically requiring ferric carboxymaltose injection as per approved prescribing information with objective to evaluate the efficacy and safety of FCM for the treatment of moderate to severe iron deficiency anemia in pregnancy.  Patients with IDA fulfilling the inclusion/exclusion criteria will be enrolled into the study. Those willing to participate and provide their health record for the purpose of study will be explained about the study through Patient Information Sheet and then asked to sign the Informed Consent Form. A unique allotment number will be given to all the enrolled patients to maintain his/her confidentiality. Data will be collected by the investigator as per the case report form (CRF) in hard copy. Patient’s demographic characteristics, significant medical history, treatment details and concomitant medications details will be recorded. This study would be of 6 weeks duration. 
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