| CTRI Number |
CTRI/2025/04/084590 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy, cost-effectiveness, and patient acceptability of ferric carboxymaltose (FCM) versus iron sucrose complex (ISC) for treatment of iron deficiency anaemia (IDA) in pregnancy |
|
Scientific Title of Study
|
Comparative evaluation of efficacy, safety, cost effectiveness and acceptability of Ferric carboxymaltose versus Iron sucrose for treatment of Iron deficiency anemia in pregnancy |
| 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 Loshini s |
| Designation |
1st year PG ,Department of OBG |
| Affiliation |
Dr.M.G.R education and research institute university |
| Address |
A.C.S Medical College and Hospital, Department of OBG, Poonamallee high road, Velappanchavadi, chennai, Tamilnadu 600077
Maduravoyl, Chennai 600095
Chennai
TAMIL NADU
600077
India |
| Phone |
9600080866 |
| Fax |
|
| Email |
loshini.subbu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi Gnanasekaran |
| Designation |
Ms (OG). Professor of department of OBG |
| Affiliation |
Dr. M.G.R educational and research institute university |
| Address |
Acs Medical College, Dept of OBG, poonamallee high road, velappanchavadi, Chennai, Tamilnadu , India 600077
Maduravoyal, Chennai 600095
Chennai
TAMIL NADU
600077
India |
| Phone |
9003166440 |
| Fax |
|
| Email |
sekaran.viji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Loshini s |
| Designation |
1st year PG ,department of OBG |
| Affiliation |
Dr.M.G.R educational and research institute university |
| Address |
A.C.S medical college and hospital , department of OBG, poonamallee high road, velappanchavadi, Chennai, Tamilnadu 600077
Maduravoyl, Chennai, 600095
Chennai
TAMIL NADU
600077
India |
| Phone |
9600080866 |
| Fax |
|
| Email |
loshini.subbu@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACS Medical college ,Dept of OBG, poonamallee high road, Velappanchavadi, chennai, Tamilnadu , India 600077 |
|
|
Primary Sponsor
|
| Name |
Dr Loshini S |
| Address |
Acs Medical College, Dept of OBG, Poonamallee high road, Velappanchavadi, chennai, Tamilnadu , India 600077 |
| 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 Loshini |
ACS medical college and hospita |
Department of OBG, ACS medical college and hospital, Poonamallee High Road, velappanchavadi,chennai, Tamilnadu
Chennai
TAMIL NADU |
9600080866
loshini.subbu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FERRIC CARBOXYMALTOSE |
Dose: 1000mg
Route: Intravenous
Frequency: once or twice ( based on requirement)
Duration of intervention:After 4 weeks of administration |
| Comparator Agent |
Iron Sucrose |
Dose: 200mg
Route: Intravenous
Frequency: Alternate days ( not exceeding 600mg per week)
Duration of intervention:After 4 weeks of administration |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
1.All pregnant women of 16-34 weeks of gestation who had been diagnosed with iron deficiency anaemia
2.All pregnant of 16-34 weeks of gestation who are noncompliant to oral iron therapy |
|
| ExclusionCriteria |
| Details |
1.Other causes anemia such as megaloblastic anemia ,sickle cell anemia, thalassemia.
2.Exclusions were chronic diseases including hepatitis and HIV, elevated serum creatinine levels, History of anaphylactic reaction to intravenous iron infusion, hemochromatosis, or other iron store sickness, significant cardiovascular disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the improvement in hemoglobin levels following administration of iron sucrose and FCM |
baseline hemoglobin will be measured. 4weeks and 8 weeks following drug administration will be checked |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine cost effectiveness, safety & acceptability of FCM & iron sucrose |
At the time of drug administration |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/04/2025 |
| 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
|
Anemia during pregnancy in India contributes to 20% of maternal death directly and 50% of maternal mortality indirectly. Anemia in pregnancy causes susceptibility towards recurrent infections, intrauterine growth restriction, preterm delivery, increased perinatal morbidity and mortality. Anemic pregnant women have increased chances of postpartum hemorrhage requiring blood transfusion leading to a longer hospital stay, reduced lactation, and postpartum mood disorders . The reasons could be poor nutrition and oral intolerance. oral therapy is not sufficient for the treatment of moderate to severe anemia, especially in the late second and third trimester. Parenteral therapy promises a better response in these patients and can obviate the need for blood transfusions in the antenatal and postpartum period. The present study is undertaken to study the efficacy and safety profile of ferric carboxy maltose in comparison to iron sucrose for the treatment of anemia in pregnancy AIM: To evaluate the efficacy, cost-effectiveness, and patient acceptability of ferric carboxymaltose (FCM) versus iron sucrose complex (ISC) for treatment of iron deficiency anemia (IDA) in pregnancy. OBJECTIVES OF THIS STUDY: · To find incidence of iron deficiency anemia in pregnant women during the study period. · To find any adverse effects during drug administration. · To check maternal and fetal outcomes. · To compare the effectiveness and safety of intravenous ferric carboxy maltose (FCM) with intravenous iron sucrose (ISC) in pregnant women with Iron deficiency anemia. |