| CTRI Number |
CTRI/2020/05/025180 [Registered on: 14/05/2020] Trial Registered Prospectively |
| Last Modified On: |
24/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Inj. Ferric Carboxymaltose (FCM) Vs Iron Isomaltoside (IIM) in treatment of iron deficiency anemia in Pregnancy (Antenatal) |
|
Scientific Title of Study
|
Inj. Ferric Carboxymaltose (FCM) Vs Iron Isomaltoside (IIM) in anemia in Pregnancy (Antenatal)- A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Garg |
| Designation |
Post Graduate Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics & Gynaecology
Jawaharlal Nehru Medical College
Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8496017030 |
| Fax |
|
| Email |
gargbhawna93@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MB Bellad |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics & Gynaecology
Jawaharlal Nehru Medical College
Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhawna Garg |
| Designation |
Post Graduate Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics & Gynaecology
Jawaharlal Nehru Medical College
Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8496017030 |
| Fax |
|
| Email |
gargbhawna93@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bhawna Garg (Principle Investigator) |
|
|
Primary Sponsor
|
| Name |
Bhawna Garg |
| Address |
Post Graduate Student Department of Obstetrics & Gynaecology
Jawaharlal Nehru Medical College
Nehru Nagar Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhawna Garg |
KLEs Dr Prabhakar Kore Hospital |
Department of OBG Antenatal clinic 10
Nehru Nagar Belagavi
Belgaum
KARNATAKA |
8496017030
gargbhawna93@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee on Human Subjects Research Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O20-O29||Other maternal disorders predominantly related to pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Iron Isomaltoside |
Injection Iron Isomaltoside is a parenteral iron formulation given to correct iron deficiency anemia. It is given intravenously according to the iron deficit calculated by Ganzonis formula. 500mg of Iron isomaltoside is given in 100ml Normal saline over 6 minutes. Studies conducted have shown that it increases level of hemoglobin earlier than Ferric Carboxymaltose and has lesser incidence of hypophosphatemia. |
| Comparator Agent |
Injection. Ferric Carboxymaltose |
Injection Ferric Carboxymaltose is a parenteral iron formulation given to correct iron deficiency anemia. It is given intravenously according to the iron deficit calculated by Ganzonis formula. It can be given upto 1000mg in a single setting. It is the standard drug given for correction of iron deficiency anemia in pregnancy according to operational guidelines under Anemia Mukt Bharat. Although it has good efficacy it has certain long term side effects like hypophosphatemia |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Antepartum women whose Hemoglobin is in range of 7 to 10.9 gram per decilitre
Women in second trimester of pregnancy (14- to 22 weeks)
|
|
| ExclusionCriteria |
| Details |
Women not willing to participate
Women with less than 14 weeks of gestation
Women in labor
Known case of Thalassemia or Megaloblastic anemia
Women who have a history or known allergy to parenteral iron infusion.
Women with normal serum ferritin levels
history of any liver disease
history of any Autoimmune disease
|
|
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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 evaluate the efficacy (rise in Haemoglobin) of Injection Iron Isomaltoside in comparison to Injection Ferric Carboxymaltose in treating Iron deficiency anemia in pregnancy. |
at 26 to 30 weeks of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate the safety in terms of local and systemic reactions and tolerability of injection Iron Isomaltoside in comparison with injection Ferric CarboxyMaltose |
immediately during drug administration till the period of 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2020 |
| Date of Study Completion (India) |
20/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a hospital based study which aims at comparing the efficacy of two parenteral iron preparations used in correction of iron deficiency anemia in pregnancy. Antenatal patients whose hemoglobin is in range of 7 to 10.9 g/dl will be screened in Antenatal Out patient department and will be screened for participation in the study. After the informed consent is taken, randomization will be done by SNOSE method. After randomisation, participants will be distinguished in two arms - Injection Iron isomaltoside and Injection Ferric Carboxymaltose. Iron deficit will be calculated by Ganzoni’s formula and accordingly iron correction will be done. 500 mg of Iron isomaltoside will be given in 100ml normal saline over 6 minutes and 500 mg of Ferric Carboxymaltose will be given in 250 ml Normal saline over 10 minutes. Drug administration will be done in ward where facilities of cardiopulmonary resuscitation are present. Vitals and fatal heart rate will be monitored prior to administration, during the administration and after the administration of drugs. Immediate side effects will be noted and patient will be observed for 30 minutes after the drug is administered for systemic and local side effects. Patient will be called up for follow up at 26-30 weeks of gestation
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