| CTRI Number |
CTRI/2026/02/103565 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision between intravenous iron sucrose and ferric carboxymaltose for treatment of anemia in pregnant women |
|
Scientific Title of Study
|
Comparative study between intravenous iron sucrose and ferric carboxymaltose for treatment of anemia in pregnant women in rural tertiary care centre : Single blind randomized control trial |
| 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 SONAM CHOUDHARY |
| Designation |
Junior resident 2 |
| Affiliation |
University of medical sciences Saifai |
| Address |
Department of Obstetrics and Gynaecology
Uttar pradesh university of medical sciences Saifai
Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7302674227 |
| Fax |
|
| Email |
sonamsanghwan786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KALPANA KUMARI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
University of medical sciences Saifai |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES SAIFAI
ETAWAH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7830516299 |
| Fax |
|
| Email |
doc.kalpana@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SONAM CHOUDHARY |
| Designation |
Junior resident 2 |
| Affiliation |
University of medical sciences Saifai |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES SAIFAI
ETAWAH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7302674227 |
| Fax |
|
| Email |
sonamsanghwan786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar pradesh university of medical sciences saifai
Etawah
206130 |
|
|
Primary Sponsor
|
| Name |
Dr Kalpana kumari |
| Address |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES SAIFAI ETAWAH 206130 |
| 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 |
| Dr Sonam Choudhary |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES SAIFAI ETAWAH 206130 |
LABOR ROOM
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Etawah
UTTAR PRADESH |
7302674227
sonamsanghwan786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferric carboxymaltose |
Calculated dose of Ferric carboxymaltose will be given as : 100 - 500 mg in 100ml NS - 15 mins duration 500 - 1000mg in 200ml NS - 30 mins duration, Subsequent doses if needed will be planned on 7th and 14th day. |
| Intervention |
Intravenous iron sucrose |
Intravenous iron sucrose 200 mg (2 ampoules of 100 mg) in 100 ml 0.9% NS over 15-30 minutes on alternate days until the total dose will be administered (not to exceed 600 mg per week). The first few ml will be infused intravenously over a period of 15 mins, if there will be no adverse reaction remaining amount will be infused over 30 mins period.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women of second and third trimester of pregnancy with moderate anemia with hemoglobin 7-9.9gm/dl and who are willing to participate in study |
|
| ExclusionCriteria |
| Details |
Non iron deficiency anemia
Bleeding disorders or coagulopathy
History of blood transfusion during antenatal period
Hypersensitivity reaction to any iron preparation
Previous surgery of intestinal resection
Co morbid conditions like cardiovascular disease chronic liver or renal disease
Medical disorders like tuberculosis, hepatitis B/C or HIV infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcomes will be measured on basis of changes in hemoglobin and iron indices like Serum Iron Serum Ferritin TIBC Transferrin saturation and safety and acceptability of intravenous iron sucrose vs ferric carboxymaltose will be determined |
Baseline on Day 0 and then on day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
21/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Anemia in pregnancy is a major public health problem in India and is associated with adverse maternal and fetal outcomes. Intravenous iron therapy is recommended in moderate to severe anemia or when oral iron is poorly tolerated or ineffective. Among the available intravenous iron preparations, iron sucrose and ferric carboxymaltose are commonly used; however, comparative data regarding their efficacy and safety in pregnant women in rural tertiary care settings are limited. This study is a single-centre, single-blind, randomized, active-controlled, parallel-group trial designed to compare the efficacy and safety of intravenous iron sucrose and ferric carboxymaltose in the treatment of anemia in pregnant women. Eligible pregnant women diagnosed with anemia will be randomly allocated into two groups. One group will recieve intravenous iron sucrose, and the other group will recieve intravenous ferric carboxymaltose, administered as per standard treatment protocols based on calculated iron requirement. The primary outcome will be the change in hemoglobin levels from baseline to follow-up and improvement in iron stores, need for additional iron therapy, and occurrence of adverse events. Participants will be assessed at baseline and during follow-up visits at predefined time points. The results of this study will help in determining the comparative effectiveness and safety of intravenous iron sucrose and ferric carboxymaltose, thereby guiding optimal management of anemia in pregnant women in rural tertiary care settings. |