| CTRI Number |
CTRI/2025/11/098214 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing which iron treatment increases Haemoglobin more effectively and safely in treating anaemia in mothers after childbirth. |
|
Scientific Title of Study
|
Effectiveness and Safety of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose among patients with postpartum iron deficiency anaemia: A randomized controlled 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 Tarun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9599634860 |
| Fax |
|
| Email |
kumart@aiimsjodhpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9599634860 |
| Fax |
|
| Email |
kumart@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Mundra |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
6377353063 |
| Fax |
|
| Email |
vaibhavmundra2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area Phase 2, Jodhpur - 342005 (Rajasthan)
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area Phase 2, Jodhpur - 342005 (Rajasthan) |
| 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 Tarun Kumar |
All India Institute of Medical Sciences, Jodhpur |
Department of Obstetrics and Gynaecology (IPD Ward 2B), Department of Biochemistry (Biochemistry Laboratory), Department of Pharmacology (Room Number 230)
Jodhpur
RAJASTHAN |
09599634860
kumart@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trial) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O908||Other complications of the puerperium, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferric Carboxymaltose |
Patients in this group will receive Intravenous Ferric Carboxymaltose in single dose as calculated by Ganzoni formula (Multiple doses may be given if iron requirement is more than 1000 mg). |
| Comparator Agent |
Ferrous Ascorbate |
Patients in this group will receive Tab Ferrous Ascorbate 100 mg twice daily for 6 weeks |
| Intervention |
Iron Sucrose |
Patients in this group will receive Intravenous Iron Sucrose in multiple divided doses as calculated by Ganzoni formula. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Females aged between 18-45 years.
2. Haemoglobin is more than or equal to 7 g/dL and less than 11 g/dL in the first 48 hours after delivery.
3. Patient is willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with haemolytic anaemia, aplastic anaemia, sickle cell anaemia and macrocytic anaemia.
2. Previous history of allergic reaction to Ferric Carboxymaltose or Iron Sucrose.
3. Patients with history of chronic heavy metal toxicity.
4. Patients suffering from chronic kidney disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose on change in Haemoglobin in postpartum iron deficiency anaemia from baseline to 6 weeks. |
Baseline, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose on change in Ferritin in postpartum iron deficiency anaemia from baseline to 6 weeks and 10 weeks. |
Baseline, 6th week, 10th week |
| To compare the effectiveness of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose on change in Haemoglobin in postpartum iron deficiency anaemia after 10 weeks postpartum. |
Baseline, 10th week |
| To evaluate the change in EPDS Score of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose in postpartum iron deficiency anaemia from baseline to 6 weeks and 10 weeks. |
Baseline, 6th week, 10th week |
| To evaluate the safety and compliance of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose in postpartum iron deficiency anaemia at baseline, 2 weeks, 6 weeks, and 10 weeks. |
Baseline, 2nd week, 6th week, 10th week |
| To compare the cost effectiveness analysis of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose in postpartum iron deficiency anaemia after 10 weeks. |
Baseline, 10th week |
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/12/2025 |
| 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="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
|
1. Background Postpartum iron deficiency anaemia is a common condition affecting 50-80 % of mothers in developing countries worldwide, contributing significantly to maternal morbidity and mortality. It is mainly caused due to anaemia in pregnancy, postpartum haemorrhage, and suboptimal iron intake during pregnancy and lactation. It can have adverse effects on both mother and child, leading to impaired mother-child bonding. It can cause chronic fatigue, reduced lactational output and caregiving, increased susceptibility to postpartum depression in mother and impaired neurodevelopmental trajectory in child. This study compares the effectiveness and safety of Ferrous Ascorbate vs Iron Sucrose vs Ferric Carboxymaltose among patients with postpartum iron deficiency anaemia.
2. Materials and Methods Participants meeting to the eligibility criteria will be recruited from the inpatient department (IPD) of Department of Obstetrics and Gynaecology at AIIMS Jodhpur. This study will involve recording of Complete Blood Count (CBC), Serum Ferritin, safety profile and compliance, EPDS (Edinburgh Postnatal Depression Scale) score, and cost effectiveness in these patients. Subsequently, the safety and effectiveness of the three drugs will be evaluated. The outcomes of the study will be determined based on the assessment at 6th and 10th weeks.
3. Implications The FOGSI (Federation of Obstetric and Gynaecological Societies in India) consensus recommends universal Hb screening of every postpartum woman prior to discharge for early diagnosis and treatment. The treatment includes ferrous ascorbate tablet and intravenous iron preparations like iron sucrose and FCM, which is given according to severity of anaemia and physician’s discretion. A single dose IV FCM after an informed decision can provide logistical benefit to patient, which is also recommended by FOGSI. However, there is paucity of head-to-head RCTs in postpartum population comparing Ferrous Ascorbate, Iron Sucrose and Ferric Carboxymaltose simultaneously. Therefore, this study is for understanding effectiveness, safety, psychological well-being outcomes, and pharmacoeconomic analysis of the three drugs. |