| CTRI Number |
CTRI/2025/02/080987 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating IV Iron Therapies for Management of Postpartum Anemia: A Comparative Study |
|
Scientific Title of Study
|
Comparative Study Of Efficacy And Safety Of Intravenous Ferric Carboxymaltose And Iron Sucrose In The Management Of Postpartum 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 |
Dr Ratnpriya |
| Designation |
Postgraduate Trainee |
| Affiliation |
Sikkim Manipal Institute Of Medical Sciences, Gangtok |
| Address |
Department of OBG, CRH, SMIMS, 5th Mile, Tadong
East
SIKKIM
737102
India |
| Phone |
8509031962 |
| Fax |
|
| Email |
ratnpriya2322@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Pradhan |
| Designation |
Professor and Head of Department, OBG |
| Affiliation |
Sikkim Manipal Institute Of Medical Sciences, Gangtok |
| Address |
Department of OBG, CRH , SMIMS,5th Mile,Tadong
East
SIKKIM
737102
India |
| Phone |
9434485334 |
| Fax |
|
| Email |
anup.p@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratnpriya |
| Designation |
Postgraduate Trainee |
| Affiliation |
Sikkim Manipal Institute Of Medical Sciences, Gangtok |
| Address |
Department of OBG, CRH, SMIMS,5th Mile,Tadong
East
SIKKIM
737102
India |
| Phone |
8509031962 |
| Fax |
|
| Email |
ratnpriya2322@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal Institute of Medical Sciences, 5th mile, Tadong, CRH campus, Gangtok, India, Pin- 737102 |
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of OBG, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok, Sikkim |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ratnpriya |
Sikkim Manipal Institute of Medical Sciences |
Department of OBG, CRH, SMIMS, 5th mile, Tadong, Gangtok, Sikkim
East
SIKKIM |
8509031962
ratnpriya2322@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sikkim Manipal Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Ferric Carboxymaltose |
It is more efficacious in rapidly increasing haemoglobin levels as compared to iron sucrose. It allows for administration of larger doses in single setting, reducing the need for multiple visits.
Route- Intravenous.
Dose is dependent on requirement through Ganzonis formula |
| Comparator Agent |
Intravenous Iron sucrose |
Iron Sucrose is effective but it requires multiple smaller doses, leading to longer treatment treatment duration. It also carries higher risk of infusion-related reactions and adverse effects.
Route- Intravenous.
Dose is dependent on requirement through Ganzonis formula |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All postpartum feamle consenting for study having hemoglobin 7 to 9.9g/dl
Iron deficiency anemia diagnosed by complete blood count with peripheral blood smear and serum ferritin levels |
|
| ExclusionCriteria |
| Details |
Allergic to parenteral Iron
Patient who did not give consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rise in hemoglobin and Serum Ferritin values |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Effects & Safety Profile |
1 YEAR |
|
|
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)
|
03/03/2025 |
| 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)
|
Open to Recruitment |
| 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
|
 Comparative Study Of
Efficacy And Safety Of Intravenous Ferric Carboxymaltose And Iron
Sucrose In The Management Of Postpartum Anemia,Summary- In this prospective interventional study spanning for a time period of 1 year, 60 patients fulfilling the criteria will be selected and then divided into 2 groups. Group A will be given parenteral ferric caboxymaltose while group B will recieve parenteral Iron sucrose.
|