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CTRI Number  CTRI/2026/02/104618 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Iron Sucrose Versus Blood Transfusion In The Management Of Moderate Post Partum Iron Deficiency Anemia. 
Scientific Title of Study   Intravenous Iron Sucrose Versus Blood Transfusion In The Management Of Moderate Post Partum Iron Deficiency Anemia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sakshi Bhojwani 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute Of Higher Education and Research  
Address  Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe),

Wardha
MAHARASHTRA
442107
India 
Phone  8180808281  
Fax    
Email  drsakshibhojwani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Meena Jotwani  
Designation  Professor  
Affiliation  Datta Meghe Institue Of Higher Education and Research 
Address  Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe),

Wardha
MAHARASHTRA
442107
India 
Phone  8180808281  
Fax    
Email  meenakhatri619@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Meena Jotwani  
Designation  Professor 
Affiliation  Datta Meghe Institute Of Higher Education and Research  
Address  Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe),

Wardha
MAHARASHTRA
442107
India 
Phone  8180808281  
Fax    
Email  meenakhatri619@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Sakshi Bhojwani 
Address  Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), 442107  
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 Sakshi Bhojwani  Acharya Vinoba Bhave Rural Hospital  Department of Obstetrics and Gynaecology, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe)
Wardha
MAHARASHTRA 
8180808281

drsakshibhojwani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commiteem  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 
Comparator Agent  Blood Transfusion  Postpartum femlae with moderate iron defieciency anemia selected after ramdomisation will be given one unit of cross-matched packed red blood cells and the level of increase in hemoglobin concentration and serrum ferritin levels will be monitored at 6 weeks. 
Comparator Agent  Iron Sucrose  Postpartum femlae with moderate iron defieciency anemia selected after ramdomisation will be given total dose of 400 mg iron sucrose. Administered as 200 mg intravenous iron sucrose diluted in 300 ml normal saline over 15-20 minutes for two consecutive days.The level of increase in hemoglobin concentration and serrum ferritin levels will be monitored at 6 weeks. 
Intervention  Iron Sucrose,Blood Transfusion  Postpartum female with moderate iron defieciency anemia selected after ramdomisation will be given either iron sucrose or blood transfusion.The level of increase in hemoglobin concentration and serrum ferritin levels will be monitored at 6 weeks between the two. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Consenting and willing for follow up postpartum women within the age group of 18 to 40 years.Women who delivered a single intrauterine live foetus.Women with hemodynamically stable status postpartum with haemoglobin concentration of 7 to 9.9 gm percent after 48 hours of delivery. 
 
ExclusionCriteria 
Details  Women with haemoglobin concentration of less than 7 gm percent (severe anaemia) or more than equal to 10 gm percent (mild anaemia). Women with excessive bleeding or with hemodynamic instability. Women delivering more than or equal to twin foetuses. Women with known hypersensitivity to either iron sucrose or blood transfusion and with known history of other atopic disorders. Women with known hemoglobinopathies like sickle cell anaemia, thalassemia, G6PD deficiency or bone marrow disorders. Women with acute or chronic infections or having pre existing significant renal or hepatic dysfunction. Women unwilling to receive blood products or iron therapy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in haemoglobin concentration serum ferritin level postpartum is the primary endpoint.  2 and 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Increase in the levels of other haematological parameters like mean corpuscular volume (MCV) , mean corpuscular haemoglobin (MCH) , mean corpuscular haemoglobin concentration (MCHC ) & reticulocyte count.  6 weeks  
 
Target Sample Size   Total Sample Size="155"
Sample Size from India="155" 
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/ Phase 4 
Date of First Enrollment (India)   15/03/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Postpartum anaemia remains a significant global health concern with prevalence rates varying between 10-40 percent of women globally. A prospective non-randomized quasi-experimental study conducted by Dhaka Medical College Hospital found that intravenous iron sucrose (600 mg administered over three days) was as effective as blood transfusion in improving haemoglobin levels and iron stores in women with moderate postpartum anaemia (Hb 7-8 g/dl). Their results showed mean Hb level increased by 4.2 g/dl in the IV iron group and 4.5 g/dl in the blood transfusion group at six weeks post-intervention, with no significant differences between groups.A study from Saudi Arabia reported postpartum anaemia prevalence of 52.percent with 55.4 percent classified as moderate anaemia. Risk factors identified include anaemia during pregnancy, primiparity, and childbirth complications.  Another comparative study found intravenous iron sucrose to be safe, efficacious, and cost-effective for treating postpartum anaemia, with minimal adverse reactions compared to blood transfusion. Research on iron sucrose therapy has demonstrated significant improvements in haemoglobin levels, serum ferritin, reticulocyte count, and other haematological parameters with negligible side effects. The average dose requirement reported in studies ranges from 300-600 mg with administration protocols typically involving divided doses given on alternate days. Multiple studies have confirmed that iron sucrose is well-tolerated, with minor side effects including nausea, vomiting, mild fever, and rare instances of thrombophlebitis. This study will provide evidence based guidance on the optimal management strategy for moderate postpartum anaemia, potentially improving maternal care protocols. Intravenous iron sucrose therapy may prove to be an effective alternative to blood transfusion, reducing transfusion-associated risks such as transfusion reactions, infections, and alloimmunization. The findings may contribute to the development of standardized protocols for managing postpartum anaemia, optimizing resource utilization in healthcare settings.

 
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