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CTRI Number  CTRI/2025/01/079458 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of injection Iron Isomaltoside with injection Iron Sucrose for treatment of iron deficiency anaemia in pregnancy  
Scientific Title of Study   Comparison of injection Iron Isomaltoside with injection Iron Sucrose for treatment of iron deficiency anaemia in pregnancy - 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 Sanchita Kochhar 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Room No 2028, Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  7898919998  
Fax    
Email  sanchitakochhar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanchita Kochhar 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Room No 2028, Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India 243006


UTTAR PRADESH
243006
India 
Phone  7898919998  
Fax    
Email  sanchitakochhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shobha Mukherjee 
Designation  Professor 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Room No 2028, Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9319854442  
Fax    
Email  shosa1974@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital, Bareilly 
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital, Bareilly 
Address  Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India 243006 
Type of Sponsor  Private 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 Sanchita Kochhar  Rohilkhand Medical College and Hospital, Bareilly  Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India 243006
Bareilly
UTTAR PRADESH 
7898919998

sanchitakochhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly, U.P.  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Iron Isomaltoside   The iron isomaltoside 1000 particle is made up of iron and a carbohydrate component, where the iron is securely held within a matrix composed of iron (III) atoms and isomaltoside pentamers. This stable structure allows for the gradual release of iron, which then binds to iron-binding proteins. A single 500 mg dose of iron isomaltoside in 100 ml NS will be administered intravenously over 20 minutes. 
Comparator Agent  Injection Iron Sucrose  Iron sucrose is a sterile aqueous solution consisting of polynuclear iron (III)-hydroxide combined with sucrose, designed for intravenous use. After being administered intravenously, it is broken down by the reticuloendothelial system into its components, iron and sucrose. A single 200 mg dose of iron sucrose in 100 ml NS will be administered intravenously over 20 mins.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women at gestation less than 36 weeks with haemoglobin between 7-10 g/dl and MCV less than 80 fl.  
 
ExclusionCriteria 
Details  Pregnant women at gestation more than or equal to 36 weeks with anaemia due to causes other than iron deficiency.
History of intolerance to parenteral iron.
History of multiple allergies.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine efficacy of injection iron isomaltoside and injection iron sucrose.
To determine adverse effects of injection iron isomaltoside.
To compare injection iron isomaltoside and injection iron sucrose. 
Outcome will be assessed at baseline, which is before intervention, and after 4 weeks of infusion. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in haemoglobin and MCV.  Follow up after 4 weeks. 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   14/02/2025 
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="0"
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 is a prevalent health issue in developing countries, including India, and is of particular concern during pregnancy due to its high occurrence and significant impact on maternal and fetal health.

According to the Centers for Disease Control and Prevention (1998), anemia in pregnant women is defined as hemoglobin levels below 11 g/dL in the first and third trimesters and below 10.5 g/dL in the second trimester, using the 5th percentile as the cutoff for iron-supplemented pregnancies.

In India, anemia is predominantly associated with iron deficiency. The National Family Health Survey (NFHS-5) reports that 52.2% of pregnant women aged 15-49 are anemic. Contributing factors include poor nutrition, increased demand from the fetoplacental unit, intestinal hookworm infection, malabsorption due to conditions like gastritis, celiac disease, and inflammatory bowel disease (IBD).

Iron deficiency anemia (IDA) can lead to a range of complications, from mild symptoms like fatigue and shortness of breath to severe, life-threatening outcomes. Adverse perinatal outcomes may include preeclampsia, infections, preterm labor, cardiac failure, and pregnancy loss. During labor, risks include shock, postpartum hemorrhage (PPH), uterine inertia, and cardiac failure. Postpartum complications may include puerperal sepsis, poor lactation, pulmonary embolism, subinvolution, and venous thrombosis. For the infant, intrauterine death (IUD) and low birth weight are potential consequences.

Recognizing IDA in pregnancy as a critical health issue, the scientific community has developed various iron formulations to address this problem, administered via oral or parenteral routes.

Despite the growing use of iron isomaltoside, there is a lack of research specifically focused on its efficacy and safety in the Indian obstetric population, where IDA is a major contributor to maternal morbidity and mortality. This study aims to compare iron isomaltoside with iron sucrose, evaluating their relative effectiveness and safety profiles.


 
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