| CTRI Number |
CTRI/2025/06/089430 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of using the drug, given as injection ferric carboxymaltose in post delivery patients with low hemoglobin levels. |
|
Scientific Title of Study
|
MANAGEMENT OF POSTPARTUM ANEMIA WITH INTRAVENOUS FERRIC CARBOXYMALTOSE |
| 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. Samreen Mirza |
| Designation |
MBBS, Junior Resident, Department of OBGY, D. Y Patil Medical College and Hospital, Kolhapur |
| Affiliation |
D.Y PATIL HOSPITAL AND RESEARCH CENTRE |
| Address |
D.Y PATIL HOSPITAL AND RESEARCH CENTRE, KADAMWADI KOLHAPUR- 416005
Kolhapur
MAHARASHTRA
416005
India |
| Phone |
8425920559 |
| Fax |
|
| Email |
samreenmirza89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Shailendra Kumbhar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
D.Y PATIL HOSPITAL AND RESEARCH CENTRE |
| Address |
104, DEPARTMENT OF OBGY, 1ST FLOOR, D.Y PATIL HOSPITAL AND RESEARCH CENTRE, KADAMWADI KOLHAPUR- 416005
Kolhapur
MAHARASHTRA
416005
India |
| Phone |
8007742444 |
| Fax |
|
| Email |
meetarchu007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Samreen Mirza |
| Designation |
MBBS, Junior Resident, Department of OBGY, D.Y Patil Medical college and Hospital, Kolhapur |
| Affiliation |
D.Y PATIL HOSPITAL AND RESEARCH CENTRE |
| Address |
D.Y PATIL HOSPITAL AND RESEARCH CENTRE, KADAMWADI KOLHAPUR- 416005
Kolhapur
MAHARASHTRA
416005
India |
| Phone |
8425920559 |
| Fax |
|
| Email |
samreenmirza89@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y PATIL HOSPITAL AND RESEARCH CENTRE, KADAMWADI KOLHAPUR- 416005 |
|
|
Primary Sponsor
|
| Name |
Dr Samreen Mirza |
| Address |
D.Y PATIL HOSPITAL AND RESEARCH CENTRE KADAMWADI KOLHAPUR 416005 |
| Type of Sponsor |
Other [myself] |
|
|
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 Samreen Mirza |
D Y PATIL MEDICAL COLLEGE AND HOSPITAL AND RESEARCH CENTRE |
FIRST FLOOR, OBGY DEPARTMENT, D.Y PATIL HOSPITAL AND RESEARCH CENTRE, KADAMWADI, KOLHAPUR- 416005
Kolhapur
MAHARASHTRA |
8425920559
samreenmirza89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 Ferric carboxymaltose |
1)Women with Hemoglobin (Hb) levels ranging from 7 gm/dL to 9.9gm/dL on day 2 of post-partum period, will be administered Ferric Carboxymaltose (FCM) transfusions tailored to their specific needs based on Ganzoni’s formula.
2)Inj. Ferric Carboxymaltose will be administered over a period of 20 minutes. 3)Hemoglobin levels along with RBC indices and peripheral smear will be meticulously recorded before the initiation of treatment and then again after 1 month & 3 months after the treatment has been concluded, to assess the efficacy of the intervention.
4)Inj. Ferric carboxymaltose compose of 50mg/ml of elemental iron. Each vial of 20ml constitutes 1000mg of elemental iron. It permits the administration of large doses (maximum of 1000 mg/infusion) in a single and rapid session (30-minute infusion).
Ganzoni’s Formula: Total iron dose = {actual body weight(kg)x [12 - actual Hb (gm/dl)] x 2.4 + iron stores (500mg), is designed to determine the most effective dose of iron for each individual, ensuring both safety and efficacy.
Prior administration of drug, test dose of 3ml will be given slowly intravenously and the patient will be observed for 5-10mins for any anaphylactic reactions to occur.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Women after 2 days of delivery with postpartum anemia
2)Hemoglobin values between 7gm/dl to 10 gm/dl
3)Women who had received blood for severe anemia in post partum period will also be included, if there Hb is below 10gm/dl.
4)Women already on oral hematinics will also be considered in the study which will act as adjunct along with Inj. Ferric Carboxymaltose.
|
|
| ExclusionCriteria |
| Details |
1)Diagnosed anemia like thalassemia, sickle cell anemia, etc.
2)Current treatment with myelosuppressive therapy.
Bleeding disorders.
3)Hypersensitivity to IV iron compounds
4)Chronic liver and kidney disorders.
5)Iron overload states, for example, hemosiderosis or hemochromatosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To estimate the efficacy of intravenous ferric carboxy maltose in treatment of postpartum anemia
2)To correlate Hb levels, RBC indices and peripheral smear before and after administration of intravenous ferric carboxymaltose and at 1 month & 3 months.
|
Hemoglobin levels, RBC indices and peripheral smear before and after administration of intravenous ferric carboxymaltose and at 1 month & 3 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2025 |
| 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) |
Open to Recruitment |
|
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
|
TITLE- “MANAGEMENT OF POSTPARTUM ANEMIA WITH INTRAVENOUS FERRIC CARBOXYMALTOSE”INTRODUCTION- World Health Organization (WHO) has defined postpartum anemia (PPA) as hemoglobin (Hb) of <10 gm% during the postpartum period. The major causes of PPA are prepartum iron deficiency and anemia in combination with acute blood losses at delivery leading to increased prevalence of tiredness, breathlessness, palpitations and may predispose to puerperal sepsis. Post-partum anemia (haemoglobin level of less than 10g/dl) is one of the commonest puerperal complications and major cause of maternal morbidity and mortality.(10) There is a strong negative correlation between iron status and depression, stress, cognitive function in mothers during the postpartum period all of which can complicate mother–child interactions. Iron deficiency is the most common nutritional deficiency globally and is the leading cause of anaemia (WHO, 2017). Oral iron therapy is the preferred treatment modality for correction of iron deficiency anemia because of its low cost and ease of use but it is associated with frequent gastrointestinal side effects, thus leading to poor compliance and may also take longer time to replenish iron stores. Parenteral iron helps in restoring iron stores faster and more effectively than oral iron without gastrointestinal side effects. Hence, postpartum IDA requires prompt intervention and high-quality care. AIM- To study the management of postpartum anemia with intravenous ferric carboxymaltose.
OBJECTIVES- 1.To estimate the efficacy of intravenous ferric carboxy maltose in treatment of postpartum anemia 2.To correlate Hb levels, RBC indices and peripheral smear before and after administration of intravenous ferric carboxymaltose and at 1 month & 3 months.
METHOD: Women with Hemoglobin (Hb) levels ranging from 7 gm/dL to 9.9gm/dL on day 2 of post-partum period, will be administered Ferric Carboxymaltose (FCM) transfusions tailored to their specific needs based on Ganzoni’s formula. Inj. Ferric Carboxymaltose will be administered over a period of 20 minutes. Hemoglobin levels along with RBC indices and peripheral smear will be meticulously recorded before the initiation of treatment and then again after 1 month & 3 months after the treatment has been concluded, to assess the efficacy of the intervention. Inj. Ferric carboxymaltose compose of 50mg/ml of elemental iron. Each vial of 20ml constitutes 1000mg of elemental iron. It permits the administration of large doses (maximum of 1000 mg/infusion) in a single and rapid session (30-minute infusion).(1) Ganzoni’s Formula: Total iron dose = {actual body weight(kg)x [12 - actual Hb (gm/dl)] x 2.4 + iron stores (500mg), is designed to determine the most effective dose of iron for each individual, ensuring both safety and efficacy. Prior administration of drug, test dose of 3ml will be given slowly intravenously and the patient will be observed for 5-10mins for any anaphylactic reactions to occur.
Outcome: To study the effect of drug for compliance & effectiveness. To study safety profile of drug. |