| CTRI Number |
CTRI/2013/05/003624 [Registered on: 09/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
30/01/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF BENEFICIAL EFFECTS OF INTRAVENOUS IRON WITH ORAL IRON IN TREATING ANEMIA FOLLOWING CHILDBIRTH. |
|
Scientific Title of Study
|
INTRAVENOUS IRON-SUCROSE COMPLEX VERSUS ORAL IRON IN THE TREATMENT OF POSTPARTUM ANEMIA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PICKLU CHAUDHURI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
N.R.S MEDICAL COLLEGE,KOLKATA |
| Address |
SHYAMVIHAR,PHASE1,BLOCK2,FLAT 2C,RFF-2,RAGHUNATHPORE,KOLKATA-700059
138,A.J.C BOSE ROAD,KOLKATA-700014.
Kolkata
WEST BENGAL
700059
India
Kolkata
WEST BENGAL
700059
India |
| Phone |
9432277443 |
| Fax |
22658179 |
| Email |
picklu.chaudhuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PICKLU CHAUDHURI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
N.R.S MEDICAL COLLEGE,KOLKATA |
| Address |
SHYAMVIHAR,PHASE1,BLOCK2,FLAT 2C,RFF-2,RAGHUNATHPORE,KOLKATA-700059
138,A.J.C BOSE ROAD,KOLKATA-700014.
Kolkata
WEST BENGAL
700059
India
WEST BENGAL
700059
India |
| Phone |
9432277443 |
| Fax |
22658179 |
| Email |
picklu.chaudhuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PICKLU CHAUDHURI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
N.R.S MEDICAL COLLEGE,KOLKATA |
| Address |
SHYAMVIHAR,PHASE1,BLOCK2,FLAT 2C,RFF-2,RAGHUNATHPORE,KOLKATA-700059
138,A.J.C BOSE ROAD,KOLKATA-700014.
Kolkata
WEST BENGAL
700059
India
WEST BENGAL
700059
India |
| Phone |
9432277443 |
| Fax |
22658179 |
| Email |
picklu.chaudhuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| NRS MEDICAL COLLEGE,KOLKATA |
|
|
Primary Sponsor
|
| Name |
NRS MEDICAL COLLEGEKOLKATA |
| Address |
138,A.J.C BOSE ROAD,KOLKATA-700014 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DRPICKLU CHAUDHURI |
DEPARTMENT OF G&O,NRS MEDICAL COLLEGE KOLKATA |
G&O OPD,ROOM NO.64
Kolkata
WEST BENGAL |
9432277443
22658179
picklu.chaudhuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTTUTIONAL ETHICS COMMITTEE,NRSMCH,KOLKATA. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
WOMEN WITH ANEMIA IN THE POSTNATAL PERIOD, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRAVENOUS IRON-SUCROSE INJECTION |
STUDY GROUP will receive200mg of iron sucrose in 100ml of normal saline and to be infused over 1 hour every alternate days till the total calculated dose is given. |
| Comparator Agent |
ORAL FERROUS SULPHATE |
CONTROL GROUP will receive tablet ferrous sulphate 200mg (60mg elemental iron) three times a day 1 hour before meals for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum women irrespective of mode of delivery who are hemodynamically stable with moderate IDA(Hb 6-8gm/dl)and serum ferritin <15 microgram/l at 24-48 hours of delivery will constitute the study population. |
|
| ExclusionCriteria |
| Details |
Thalassaemic trait, peripartum blood trasfusion,active postpartum hemorrhage, allergy or intolerence to iron preparation previously, evidence of sepsis , hepatic, cardiovascular ,renal ,thrmoembolic disorder . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemoglobin , haematocrit , red cell indices,serum ferritin |
0,7,14,40 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects and complications |
0,7,14,40 days. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2012 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Moderate to severe Iron deficiency anemia is prevalent in women following childbirth especially in resource poor countries.Any method to treat IDA is relevant from socio-economic point of view. This study aims to find out the efficacy of intravenous iron sucrose in improving haemoglobin and other parameters in comparison to oral iron in postpartum anemic women.
|