| 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
|
|
|
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
|
|
|
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. |
|
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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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