| 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
|
|
|
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
|
|
|
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
|
|
|
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. |