| CTRI Number |
CTRI/2024/10/075061 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of efficacy and safety of Ferric
carboxy maltose and Iron sucrose for the treatment of Iron Deficiency anemia in pregnancy |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY AND SAFETY OF FERRIC CARBOXYMALTOSE AND IRON SUCROSE FOR TREATMENT OF IRON DEFICIENCY ANEMIA IN PREGNANCY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K P Mohanasundari |
| Designation |
HOD and Professor |
| Affiliation |
Government Medical College and Hospital Tiruppur |
| Address |
BLOCK C
DEPARTMENT OF OBSTETRICS AND GYNAECOOGY
Government Medical College and Hospital
Tiruppur
Coimbatore
TAMIL NADU
641605
India |
| Phone |
09894460190 |
| Fax |
|
| Email |
m72sundari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K P Mohanasundari |
| Designation |
HOD and Professor |
| Affiliation |
Government Medical College and Hospital Tiruppur |
| Address |
BLOCK C
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Government Medical College and Hospital
Tiruppur
Coimbatore
TAMIL NADU
641605
India |
| Phone |
09894460190 |
| Fax |
|
| Email |
m72sundari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B Nithya Devi |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College and Hospital Tiruppur |
| Address |
BOCK C
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Government Medical College and Hospital
Tiruppur
Coimbatore
TAMIL NADU
641605
India |
| Phone |
09677809024 |
| Fax |
|
| Email |
nithyadevibalu@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMS Campus, 5th floor
teynampet, chennai
Tamil Nadu, India, 600006 |
|
|
Primary Sponsor
|
| Name |
National Health Mission |
| Address |
DMS Campus, 5th floor
TNHSP teynampet,chennai,
Tamil Nadu, 600006
chennai |
| Type of Sponsor |
Government funding agency |
|
|
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 K P Mohanasundari |
Government Medical College Tiruppur |
BLOCK C, MCH building
Department of Obstetrics and Gynaecology, tiruppur
Coimbatore
TAMIL NADU |
9894460190
m72sundari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government Medical College Tiruppur Institution Human Ethical Committee |
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 |
FERRIC CARBOXYMALTOSE |
500mg IV 3 doses, 6 MONTHS |
| Comparator Agent |
IRON SUCROSE |
200mg IV 6 doses, 6 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All AN mothers between 14-32weeks of gestation with moderate anemia |
|
| ExclusionCriteria |
| Details |
All AN mothers before 14weeks and after 32weeks of gestation with moderate anemia.
All AN mothers with severe anemia in all 3 trimesters.
AN mothers who received blood transfusion in this pregnancy.
AN mothers hypersensitive to any iron preparation.
AN mothers with liver disorder like Jaundice, cirrhosis.
AN mother’s with acute Cardiac failure or Renal failure.
AN mother’s with known case of hemolytic anemia. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Increase in HB |
AFTER 3WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EFFECACY AND SAFETY OF FERRIC CARBOXY MALTOSE AND IRON SUCROSE IN PREGNANCY |
6MONTHS |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
10/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To evaluate the efficacy and safety of intravenous Ferric Carboxy maltose and Iron sucrose for treatment of iron deficiency anemia in pregnancy.FCM brings about greater and faster Hb increase in treatment of anemia. FCM usually requires a shorter administration time approximately 15mins. Maximum 2 doses (1500mg) is administrated as OP procedure. Need of further Blood transfusion in future also gets reduced. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting.
|