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CTRI Number  CTRI/2023/07/055752 [Registered on: 27/07/2023] Trial Registered Prospectively
Last Modified On: 18/07/2023
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 with blood transfusion for anemia in postpartum women. 
Scientific Title of Study   Comparison of intravenous iron isomaltoside versus blood transfusion for treatment of moderate anemia in postpartum women:A Randomised controlled trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Kumari 
Designation  Professor  
Affiliation  Rajendra institute of medical sciences,Ranchi 
Address  Department of Obstetrics and gynaecology,RIMS, Ranchi
Dept. of Obgy, RIMS, Ranchi
Ranchi
JHARKHAND
834009
India 
Phone  9471521226  
Fax    
Email  dr_karchana@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Kritika Srivastava 
Designation  Junior resident 
Affiliation  Rims,Ranchi 
Address  Department of Obstetrics and gynaecology,RIMS,Ranchi
Dept. of Obgy,Rims,Ranchi
Ranchi
JHARKHAND
834009
India 
Phone  7209907001  
Fax    
Email  drkritika25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kritika Srivastava 
Designation  Junior Resident 
Affiliation  RIMS,Ranchi 
Address  Department of Obstetrics and gynaecology, RIMS, Ranchi
Dept. of Obgy,RIMS,Ranchi

JHARKHAND
834009
India 
Phone  7209907001  
Fax    
Email  drkritika25@gmail.com  
 
Source of Monetary or Material Support  
RIMS,Ranchi 
 
Primary Sponsor  
Name  Rajendra institute of medical sciences  
Address  Rajendra institute of medical sciences, Bariatu,Ranchi  
Type of Sponsor  Government medical college 
 
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 Kritika Srivastava  Department of Obstetrics and gynaecology, Rajendra institute of medical sciences  Bariatu,Ranchi
Ranchi
JHARKHAND 
7209907001

drkritika25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,RIMS,Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparison of intravenous iron isomaltoside versus blood transfusion for the treatment of moderate anemia in postpartum women.  The Iv iron group will receive Intravenous iron isomaltoside which will be diluted in 200cc of normal saline and infused over 30minutes, and patient will be monitored for any adverse reactions . The tranfusion group will be transfused 1 unit packed RBCs after proper grouping and cross matching and continuous monitoring of patients vitals as well as for any adverse reaction will be done. Women will be monitored for drug as well as blood transfusion side effects,based on general condition and monitoring vital parameters like blood pressure,pulse rate,respiratory rate and saturation and any adverse reaction will be noted and immediately managed. 
Comparator Agent  Intravenous iron isomaltoside   Iv iron isomaltoside single dose of 1000mg diluted in 200ml normal saline infused over 30minutes 
Comparator Agent  Packed RBC transfusion   One unit packed red blood cells will be transfused after proper grouping and cross matching .patients will be monitored for any adverse reactions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. women clinically anemic or complicated with anemic symptoms irrespective of mode of delivery with hemoglobin measured 12hrs after delivery ranging between 7-9g/dl.
2. women who are willing to participate in the study and have signed the informed consent form.
 
 
ExclusionCriteria 
Details  1. Women with hemodynamic instability.

2. Women with history of Blood transfusion during pregnancy or after delivery
3. Women with multiple allergies,or any acute infection.

4. Women with any hemoglobinopathies.or hemolytic anemia or any chronic illness like chronic liver disease, chronic kidney disese, HELLP syndrome etc.
5. Women with history of adverse events following any injectable iron preparations in the past.
6. Women with known case of iron overload or disturbance in iron absorption eg.Hemochromatosis, Hemosiderosis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of intravenous iron isomaltoside vs blood transfusion in treatment of moderate anemia in postpartum females.  At baseline,3rd week and 6th week. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the number ,type of adverse effects with iv iron isomaltoside vs blood transfusion.  Day 1 ,6th week 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 
Date of First Enrollment (India)   10/08/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Anemia is a common problem across all age groups with a higher burden among women anemia is one of the prominent haematological menifestation during pregnancy and post parfumerie period. The post parfumerie period is an often neglected period for the provision of effective care to the mothers Anemia during post natal period is a major public health problem worldwide. Postpartum anemia alters the emotion and cognition and is also associated with postpartum depression. It also plays an important role in decreased milk production and immunity. In India 52% women have some degree of anemia .
There is an increasing concern about the adverse effects of the current transfusion practice Adverse effects of transfusion include increased iatrogenic infections, volume overload and number of immunologic adverse effects and may complicate future transfusions and pregnancies. An alternative treatment is therefore warranted to diminish RBC transfusion related risks in otherwise healthy women with moderate and severe postpartum anemia. Intravenous iron isomaltoside is an alternative to blood transfusions in the management of moderate anemia in postpartum females, as iron deficiency is by far the most common cause of anemia.Iron isomaltoside has an advantage of one dose iron repletion and iron concentration 100mg/ml which is much higher than other iron preparation and no test dose is required. 
Jharkhand being one of the underdeveloped states of India has a high burden of postpartum anemia,so study for management of post partum anemia s absolute necessity to combat this problem and help in prevention of morbidity and mortality related to anemia. 
Aim of the study is to compare the effectiveness of iron isomaltoside over blood transfusion for treatment of moderate anemia in postpartum females based on changes in hemoglobin level,iron biochemical parameters and resolution of anemic symptoms.

Study population will be all post partum women coming to RIMS labor room and Opd giving consent for the study. Computer generated Random numbers will be used for randomisation and simple randomisation will be used to allocate two groups in equal halves. If iron group will be receiving single dose iron isomaltoside after calculating iron deficit and transfusion group will receive RBC transfusion and will be monitored for any adverse reactions from both which will be immediately managed.

Follow up will be done on day 1post transfusion ,3rd week and 6th week, and hemoglobin levels, iron biochemical parameters and anemic symptoms will be compared.

With this background this study is proposed to evaluate the feasibility and explorative outcomes of high single dose iron isomaltoside compared with RBC transfusion for treatment of moderate postpartum anemia in hemodynamically stable women.

 
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