| CTRI Number |
CTRI/2025/06/088786 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of parenteral iron administration in pregnant women with less than 32 weeks of gestation with moderate to severe iron deficiency anaemia . An experimental study . |
|
Scientific Title of Study
|
To assess the effect of parenteral iron administration in pregnant women with less than 32 weeks of gestation with moderate to severe iron deficiency anemia - An experimental study |
| 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 NIDHI |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
| Address |
OPD 190
Department of obstetrics and gynaecology
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur
OPD 190
Department of obstetrics and gynaecology
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9205258284 |
| Fax |
|
| Email |
Nidhithakran08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Dabholkar |
| Designation |
Professor |
| Affiliation |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
| Address |
OPD 190
Department of obstetrics and gynaecology
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9511481415 |
| Fax |
|
| Email |
explain4you@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Dabholkar |
| Designation |
Professor |
| Affiliation |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
| Address |
OPD 190
Obstetrics and gynaecology
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9511481415 |
| Fax |
|
| Email |
explain4you@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nidhi |
| Address |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
| Type of Sponsor |
Other [Self] |
|
|
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 Nidhi |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
Department of obstetrics and gynaecology
Shahjahanpur
UTTAR PRADESH |
9205258284
Nidhithakran08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Varun Varun Medical College Banthara Shahjahanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
To study the effect parenteral iron transfusion in pregnant women |
To assess the effect of parenteral iron transfusion in pregnant women with ess than 32 weeks of gestation with moderate to severe iron deficiency anemia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant females with age above 18 years and below 40 years .
2.Pregnant females with lab confirmed moderate-severe iron deficiency anemia and have not crossed 32 weeks . |
|
| ExclusionCriteria |
| Details |
1. Pregnant females who do not meet the age criteria mentioned above.
2.Pregnant females with anemia which is not due to iron deficiency.
3.Pregnant females with mild iron deficiency anemia and have not crossed 32 weeks .
4. Pregnant females who do not give informed written consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the improvement in haemoglobin status after iron sucrose transfusion. |
To study the improvement in haemoglobin status after iron sucrose transfusion at the end of 8 weeks or on admission in labor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
23/06/2025 |
| 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)
|
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
|
Iron deficiency anaemia is one of the most prevalent nutritional deficiencies worldwide. Pregnant women are highly susceptible to iron deficiency anaemia with a prevalence of 56% in India . Iron sucrose transfusion play an important role in management of iron deficiency anaemia in pregnancy. Therefore I will study the effect of iron sucrose transfusion in pregnant women with less than 32 weeks gestation with moderate (Hb-9.9-7g/dl) to severe (Hb<7g/dl) iron deficiency anaemia. |