| 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
|
|
|
Primary Sponsor
|
| Name |
Rajendra institute of medical sciences |
| Address |
Rajendra institute of medical sciences, Bariatu,Ranchi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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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