CTRI/2023/02/049803 [Registered on: 17/02/2023] Trial Registered Prospectively
Last Modified On:
15/02/2023
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A CLINICAL TRIAL TO STUDY THE EFFECT OF TWO DRUGS, FERRIC-CARBOXY MALTOSE AND IRON SUCROSE COMPLEX FOR TREATMENT OF IRON DEFICIENCY ANEMIA IN PREGNANT WOMEN
Scientific Title of Study
COMPARISON OF IRON SUCROSE COMPLEX AND FERRIC CARBOXYMALTOSE FOR TREATMENT OF IRON DEFICIENCY ANEMIA IN ANTE-PARTUM PATIENTS: A RANDOMIZED CONTROL TRIAL
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ankit Kumar Dangi
Designation
Post MBBS Primary DNB Resident
Affiliation
Bhagat Phool Singh Govt. Medical College for Women, Khanpur kalan, Sonepat
Address
F-54 , Bhagat Phool Singh Govt. Medical College for Women, Khanpur kalan, Sonepat, Haryana
Sonipat HARYANA 131305 India
Phone
8295857574
Fax
Email
drankitkumardangi@gmail.com
Details of Contact Person Scientific Query
Name
Dr SUNITA SIWACH
Designation
PROFESSOR
Affiliation
Bhagat Phool Singh Govt. Medical College for Women, Khanpur kalan, Sonepat
Address
Dept of OBS & Gynae , Bhagat Phool Singh Govt. Medical College for Women, Khanpur kalan, Sonepat, Haryana
Sonipat HARYANA 131305 India
Phone
9812266400
Fax
Email
siwachsunita@ymail.com
Details of Contact Person Public Query
Name
Dr Ankit Kumar Dangi
Designation
Post MBBS Primary DNB Resident
Affiliation
Bhagat Phool Singh Govt. Medical College for Women, Khanpur kalan, Sonepat
Address
F-54 , Bhagat Phool Singh Govt. Medical College for Women, Khanpur kalan, Sonepat, Haryana
Sonipat HARYANA 131305 India
Phone
8295857574
Fax
Email
drankitkumardangi@gmail.com
Source of Monetary or Material Support
BPS Govt. Medical College for Women, Khanpur kalan, Sonepat, Haryana 131305
Primary Sponsor
Name
BPS Govt. Medical College for Women, Khanpur kalan
Address
BPS Govt. Medical College for Women, Khanpur kalan, Sonepat, Haryana 131305
Type of Sponsor
Government medical college
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ankit Kumar Dangi
BPS Govt. Medical College for Women, Khanpur kalan
Ward No:2-Department of Obstetrics and Gynaecology, BPS Govt. Medical College for Women, Khanpur kalan, Sonepat, Haryana 131305 Sonipat HARYANA
8295857574
drankitkumardangi@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee BPS Govt. Medical College for Women, Khanpur kalan
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium,
Ante-partum women
Age between 18 to 35 years.
Hemoglobin between 6-9.9 gm %..
Iron deficiency anemia
24-34 weeks of period of gestation
ExclusionCriteria
Details
Other than Iron Deficiency Anemia
Acute or Chronic Liver diseases
HIV
1st Trimester of Pregnancy
Serum transaminases > 1.5 times upper limit of normal
Serum Creatinine > 2.0 mg/dL
History of allergic reaction to intravenous iron infusion
Anemia due to other causes Thalassemia patient
Iron metabolic disorder
Hemosiderosis
Hemochromatosis
Untreated Pyelonephritis
Anaphylactic Reaction
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in Hb level from baseline on follow-up visits
baseline, 3 weeks, 6 weeks, 9 weeks
Secondary Outcome
Outcome
TimePoints
Change in RBC indices, RDW, change in serum ferritin levels,change in fatigue levels, safety and side effects of treatment and peri-natal outcome (in terms of time of delivery/ abortion/preterm delivery)
baseline, 3 weeks, 6 weeks, 9 weeks
Target Sample Size
Total Sample Size="220" Sample Size from India="220" 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 3/ Phase 4
Date of First Enrollment (India)
28/02/2023
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="1" Days="1"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
not yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Whether parenteral iron therapy in form on ferric carboxymaltose in terms of efficacy, safety and compliance has advantage over iron sucrose complex for treatment of iron deficiency anemia in ante-partum patients?
Women presenting with iron deficiency anemia and Hb 6-9.9gm % will be randomized based computer generated block randomization technique in group 1 or group 2.
Group1:- will be formed by the patients receiving Ferric Carboxymaltose
Group 2:- will be formed by the patients receiving iron sucrose complex.
Follow-up visits will be done after 3, 6 and 9 weeks from start of treatment. Primary outcome to note will be change in Hb level from baseline on follow-up visits. Secondary outcomes will be change in RBC indices, RDW, change in serum ferritin levels, change in fatigue levels(LASA to measure improvements in fatigue scores and a 10 point numeric scale to assess the feeling of well-being), safety and side effects of treatment and peri-natal outcome (in terms of time of delivery/ abortion/preterm delivery).