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CTRI Number  CTRI/2022/07/044023 [Registered on: 14/07/2022] Trial Registered Prospectively
Last Modified On: 12/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of intravenous iron preparations to treat iron-deficiency anemia in antepartum women 
Scientific Title of Study   Randomised control study of intravenous ferric carboxymaltose versus iron sucrose in treatment of iron deficiency anemia among antepartum women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinita Gupta 
Designation  Consultant  
Affiliation  Dept. of Obstetrics & Gynecology, Dr. Baba Saheb Ambedkar Medical College and Hospital 
Address  Dept. of Obstetrics and Gynecology, Dr Baba Saheb Ambedkar Medical Collge and hospital
Rohini, sector-6
New Delhi
DELHI
110085
India 
Phone  9560773962  
Fax    
Email  vinitagupta24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vinita Gupta 
Designation  Consultant  
Affiliation  Dept. of Obstetrics & Gynecology Dr. Baba Saheb Ambedkar Medical College and Hospital 
Address  Dr Baba Saheb Ambedkar Medical College and Hospital
Rohini Sector 6
New Delhi
DELHI
110085
India 
Phone  9560773962  
Fax    
Email  vinitagupta24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vinita Gupta 
Designation  Consultant  
Affiliation  Dept. of Obstetrics & Gynecology Dr. Baba Saheb Ambedkar Medical College and Hospital 
Address  Dr Baba Saheb Ambedkar Medical College and Hospital
Rohini Sector 6
New Delhi
DELHI
110085
India 
Phone  9560773962  
Fax    
Email  vinitagupta24@gmail.com  
 
Source of Monetary or Material Support  
Dr Baba Saheb Ambedkar Medical College and Hospital 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [no sponsor available] 
 
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 sarita mishra  dr baba saheb ambedkar medical collge and hospital  dept. of obstetrics and gynecology, rohini, sector-6
New Delhi
DELHI 
8896477438

saritamishra565@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics committee academic section  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  intravenous ferrous carboxy-maltose  ferrous carboxy-maltose to be given intravenously in a single dose calculated by ganzonis formula. maximum dose 1000mg/week. iv preparation tobe given over 6-15mins in 100-250ml 0.9%NS. 
Comparator Agent  intravenous iron-sucrose complex   iron sucrose complex to be given intravenously on alternate days in equally divided doses with maximum dose of 600mg/week and calculated by ganzonis formula. iv preparation to be given over 15-20mins in 100ml of 0.9%NS . 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  pregnant women between gestation age 16-34 weeks with Hb between 7-9.9 gm/dl and failed oral supplementation therapy of iron. 
 
ExclusionCriteria 
Details  pregnant patients with allergy to iron therapy previously, known medical illness such as asthma, thromboembolism, requiring emergency cesarean section and negative consent. patient who requires blood transfusion for severe anemia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to measure the improvement in hematological parameters such as Hb, RBC indices and serum ferritin between group A and group B  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
adverse effects and side effects  6 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   24/07/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not available 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Anemia is one of the major health issues worldwide and during pregnancy, it is associated with increased morbidity & mortality of pregnant women and the developing fetus. Anemia in india contributes as cause of 20% maternal death directly and 50% for associated causation. Iron- deficiency anemia is most common type of nutritional deficiency (but manageable) affecting both developed and developing countries. Oral iron supplementation is most effective way of therapy, but parenteral iron is reserved for patients who are either intolerant to oral therapy, non-compliant or having malabsorption from the gut.

Our study compares the efficacy & safety of parenteral ferric carboxy maltose (FCM) vs iron-sucrose complex for treatment of iron deficiency anaemia in pregnant women. The primary objective is to compare the improvement in haematological parameters like hb, red cell indices (MCV, MCHC, RDW, haematocrit) & serum ferritin in both groups and compare the adverse drug reactions. Secondary objective is to study and compare the number of units of drug utilized, duration & cost of therapy.

 This prospective Randomized controlled study will be done in the Department of obstetrics & gynaecology, dr. baba Saheb Ambedkar, medical college & hospital (sector 6, Rohini, new Delhi) over a period of 1 year. Pregnant women between 16-34 weeks of gestation and Haemoglobin level 7-9.9 gm/dl who are non-compliant or failed to respond to oral haematinics attending antenatal OPD, emergency OPD & antenatal ward will be enrolled in the study after giving consent and will further be assigned to group A or group B (30 in each) respectively. Total iron dose required will be calculated by using Ganzoni’s formula taking into account the target Haemoglobin post-correction as per WHO which is maximum 11 gm/dl. Group A will receive intravenous ferric carboxymaltose (FCM) and group B will receive intravenous iron- sucrose complex as per the standard dosing regime. Patients will be observed for adverse reactions & side effects till 1 hour after infusion and the same will be documented.

All patients will be followed-up on OPD basis at 2nd and 6th week after completion of treatment with their blood investigations namely haemoglobin, RBC indices (MCV, MCHC, RDW, HCT) and serum ferritin. Data will be entered in MS-EXCEL spreadsheet and will be analysed using SPSS version 21.

 

 
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