CTRI Number |
CTRI/2022/07/044023 [Registered on: 14/07/2022] Trial Registered Prospectively |
Last Modified On: |
12/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
comparison of intravenous iron preparations to treat iron-deficiency anemia in antepartum women |
Scientific Title of Study
|
Randomised control study of intravenous ferric carboxymaltose versus iron sucrose in treatment of iron deficiency anemia among antepartum women |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vinita Gupta |
Designation |
Consultant |
Affiliation |
Dept. of Obstetrics & Gynecology, Dr. Baba Saheb Ambedkar Medical College and Hospital |
Address |
Dept. of Obstetrics and Gynecology, Dr Baba Saheb Ambedkar Medical Collge and hospital Rohini, sector-6 New Delhi DELHI 110085 India |
Phone |
9560773962 |
Fax |
|
Email |
vinitagupta24@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vinita Gupta |
Designation |
Consultant |
Affiliation |
Dept. of Obstetrics & Gynecology Dr. Baba Saheb Ambedkar Medical College and Hospital |
Address |
Dr Baba Saheb Ambedkar Medical College and Hospital Rohini Sector 6 New Delhi DELHI 110085 India |
Phone |
9560773962 |
Fax |
|
Email |
vinitagupta24@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vinita Gupta |
Designation |
Consultant |
Affiliation |
Dept. of Obstetrics & Gynecology Dr. Baba Saheb Ambedkar Medical College and Hospital |
Address |
Dr Baba Saheb Ambedkar Medical College and Hospital Rohini Sector 6 New Delhi DELHI 110085 India |
Phone |
9560773962 |
Fax |
|
Email |
vinitagupta24@gmail.com |
|
Source of Monetary or Material Support
|
Dr Baba Saheb Ambedkar Medical College and Hospital |
|
Primary Sponsor
|
Name |
none |
Address |
none |
Type of Sponsor |
Other [no sponsor available] |
|
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 sarita mishra |
dr baba saheb ambedkar medical collge and hospital |
dept. of obstetrics and gynecology, rohini, sector-6 New Delhi DELHI |
8896477438
saritamishra565@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ethics committee academic section |
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 |
Intervention |
intravenous ferrous carboxy-maltose |
ferrous carboxy-maltose to be given intravenously in a single dose calculated by ganzonis formula. maximum dose 1000mg/week. iv preparation tobe given over 6-15mins in 100-250ml 0.9%NS. |
Comparator Agent |
intravenous iron-sucrose complex |
iron sucrose complex to be given intravenously on alternate days in equally divided doses with maximum dose of 600mg/week and calculated by ganzonis formula. iv preparation to be given over 15-20mins in 100ml of 0.9%NS . |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
pregnant women between gestation age 16-34 weeks with Hb between 7-9.9 gm/dl and failed oral supplementation therapy of iron. |
|
ExclusionCriteria |
Details |
pregnant patients with allergy to iron therapy previously, known medical illness such as asthma, thromboembolism, requiring emergency cesarean section and negative consent. patient who requires blood transfusion for severe anemia |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
to measure the improvement in hematological parameters such as Hb, RBC indices and serum ferritin between group A and group B |
6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
adverse effects and side effects |
6 weeks |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
24/07/2022 |
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
|
not available |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Anemia is one of the major health issues worldwide and during pregnancy, it is associated with increased morbidity & mortality of pregnant women and the developing fetus. Anemia in india contributes as cause of 20% maternal death directly and 50% for associated causation. Iron- deficiency anemia is most common type of nutritional deficiency (but manageable) affecting both developed and developing countries. Oral iron supplementation is most effective way of therapy, but parenteral iron is reserved for patients who are either intolerant to oral therapy, non-compliant or having malabsorption from the gut. Our study compares the efficacy & safety of parenteral ferric carboxy maltose (FCM) vs iron-sucrose complex for treatment of iron deficiency anaemia in pregnant women. The primary objective is to compare the improvement in haematological parameters like hb, red cell indices (MCV, MCHC, RDW, haematocrit) & serum ferritin in both groups and compare the adverse drug reactions. Secondary objective is to study and compare the number of units of drug utilized, duration & cost of therapy. This prospective Randomized controlled study will be done in the Department of obstetrics & gynaecology, dr. baba Saheb Ambedkar, medical college & hospital (sector 6, Rohini, new Delhi) over a period of 1 year. Pregnant women between 16-34 weeks of gestation and Haemoglobin level 7-9.9 gm/dl who are non-compliant or failed to respond to oral haematinics attending antenatal OPD, emergency OPD & antenatal ward will be enrolled in the study after giving consent and will further be assigned to group A or group B (30 in each) respectively. Total iron dose required will be calculated by using Ganzoni’s formula taking into account the target Haemoglobin post-correction as per WHO which is maximum 11 gm/dl. Group A will receive intravenous ferric carboxymaltose (FCM) and group B will receive intravenous iron- sucrose complex as per the standard dosing regime. Patients will be observed for adverse reactions & side effects till 1 hour after infusion and the same will be documented. All patients will be followed-up on OPD basis at 2nd and 6th week after completion of treatment with their blood investigations namely haemoglobin, RBC indices (MCV, MCHC, RDW, HCT) and serum ferritin. Data will be entered in MS-EXCEL spreadsheet and will be analysed using SPSS version 21. |