| CTRI Number |
CTRI/2010/091/001290 [Registered on: 18/10/2010] |
| Last Modified On: |
23/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
A clinical trial to compare the rise in hemoglobin and serum ferritin levels after giving either intravenous iron sucrose or oral ferrous ascorbate to anemic pregnant women. |
Scientific Title of Study
Modification(s)
|
Iron Deficiency Anemia in Pregnancy:Intravenous Versus Oral Route |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr deeba shafi |
| Designation |
|
| Affiliation |
|
| Address |
602,Jairaj CHS,Opposite Income tax bldg no13.
bandra kurla complex,Bandra (east)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022 26591247,09820045199 |
| Fax |
22617386 |
| Email |
deebashafi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr deeba shafi |
| Designation |
|
| Affiliation |
|
| Address |
602,Jairaj CHS,Opposite Income tax bldg no13.
bandra kurla complex,Bandra (east)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022 26591247,09820045199 |
| Fax |
22617386 |
| Email |
deebashafi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr deeba shafi |
| Designation |
|
| Affiliation |
|
| Address |
602,Jairaj CHS,Opposite Income tax bldg no13.
bandra kurla complex,Bandra (east)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022 26591247,09820045199 |
| Fax |
22617386 |
| Email |
deebashafi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Deeba Shafi |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deeba Shafi |
K.J.Somaiya Medical College and Research Centre |
Ayurvihar,near everard nagar,,Eastern express highway,Sion-400022
Mumbai
MAHARASHTRA |
022 24090253
24091855
somaiyamedical@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for research on human subjects.(Ehics committee/IRB of K.J.Somaiya medical college and hospital,Mumbai)[Established 1997] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Iron Deficiency Anemia in pregnancy., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous iron sucrose |
Total dose required=2.4xweightxhemoglobindeficit+500.(target hemoglobin =12gm/dl) |
| Comparator Agent |
oral ferrous ascorbate |
200 mg daily |
|
Inclusion Criteria
Modification(s)
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women between 28 and 37 weeks of gestation.
hemoglobin between 6 and 10gm%
iron deficiency anemia.
|
|
| ExclusionCriteria |
| Details |
Anemia from cause other than iron deficiency.
Multiple pregnancy
History of previous blood transfusion.
History of hematological disease.
Risk of preterm labour.
Intolerance to iron derivatives.
Recent administration of iron.
Current usage of iron supplements |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| increase in hemoglobin in g/dl |
increase in hemoglobin at 2weeks,4 weeks and at 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increse in serum ferritin levels from baseline. |
increase at 2 weeks, 4weeks an at 6 weeks. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
27/02/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
27/02/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The Journal of Obstetrics and Gynecology of India(May-June 2012)62(3):322-326 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized experimental study with two arms, comparing the efficacy of intravenous iron sucrose and oral ferrous ascorbate in increasing hemoglobin and serum ferritin levels in pregnant women between 28 and 37 weeks of gestation with hemoglobin between 6 and 10gm/dl.Iron sucrose dose required is calculated as 2.4xweight of the patient x hemoglobin deficit+500.Target hemoglobin set at 12gm/dl.One arm(100 patients) are given iron sucrose intravenously. Other arm(100 patients )are given oral ferrous ascorbate 200mg till 6 weeks. The primary outcome will be increase in hemoglobin from baseline at 2weeks,4 weeks an 6 weeks in both groups. The secondary outcome will be rise in serum ferritin levels at 2 weeks,4weeks and 6weeks in both groups. |