| CTRI Number |
CTRI/2020/12/029785 [Registered on: 14/12/2020] Trial Registered Prospectively |
| Last Modified On: |
21/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Ferric Carboxymaltose Injection in Pregnant women:
Retrospective analysis |
|
Scientific Title of Study
|
Efficacy and Safety of Ferric Carboxymaltose Injection in Pregnant women:
Retrospective analysis at Indian Real-life Scenario |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Gupte |
| Designation |
Director and Obstetrician gynecologist |
| Affiliation |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
Ground Floor, Obstetrics And Gynaecology Department
Gupte Hospital and Centre for Research in Reproduction
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
guptehospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Mudholkar |
| Designation |
Senior Gynaecologist Obstetrician Doctor |
| Affiliation |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
Room no. 101, First floor, Obstetrics And Gynaecology Department
Gupte Hospital and Centre for Research in Reproduction
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
aparnajayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Jangam |
| Designation |
Clinical Research Associate |
| Affiliation |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
Third floor, Clinical Research Divison
Gupte Hospital and Centre for Research in Reproduction
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
research.gupte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gupte Hospital |
| Address |
904 Bhandarkar Rd Ganeshwadi Deccan Gymkhana Pune Maharashtra 411004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aparna Mudholkar |
Gupte Hospital |
Obstetrics And Gynaecology Department
Pune
MAHARASHTRA |
9881045069
aparnajayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee Dhanashree Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, (2) ICD-10 Condition: O251||Malnutrition in pregnancy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant female patients aged more than 18 years of age who visited to department of Obstetrics and Gynecology in their 2nd and 3rd trimester of gestation.
2. Documented Iron deficiency anemia and received FCM injection.
3. Data for hematological parameters (hemoglobin, serum ferritin) are available at baseline and for minimum at 4 ± 2 weeks.
4. Patients already provided informed consent for future use of their medical records for research.
|
|
| ExclusionCriteria |
| Details |
1. Any other type of anemia apart from Iron Deficiency anemia
2. Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis).
3. Any malignancy.
4. Presence of active liver disease/ HBV or HCV infection, CKD, HIV infection / AIDS, asthma, or rheumatoid arthritis.
5. Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hemoglobin level from baseline to week 4 (± 2) |
Baseline to week 4 (± 2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in serum ferritin levels
2. Change in hematological parameters (PCV, MCV, MCH, MCHC) if available
3. Change in serum iron levels, if available
4. Change in TSAT value, if available
5. The adverse events: incidence, severity and relation to FCM will be retrieved and analyzed. |
Baseline to week 4 (± 2) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "168"
Final Enrollment numbers achieved (India)="168" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/12/2020 |
| Date of Study Completion (India) |
19/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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)?
Response - NO
|
|
Brief Summary
|
Iron Deficiency Anemia (IDA) is prevalent in Indian pregnant women; around 47% of women suffer from anemia during pregnancy. If IDA remains untreated during pregnancy it can cause perinatal mortality as well as maternal mortality. Therapy for ID includes mainly dietary modification, oral iron supplementation and some cases intravenous iron and blood transfusion. Oral iron therapy is mainstay in treating IDA in pregnancy but it also has associated gastrointestinal side effects. Oral iron therapy is not adequate to treat moderate to severe anemia in the late second and third trimester. Parenteral iron therapy is the treatment of choice in this condition. FCM is an attractive alternative to iron sucrose complex (ISC) in terms of safety, efficacy, convenience, and resource utilization. Very little literature is available on the use of FCM in pregnancy and there are limited prospective studies on FCM in pregnancy also. Therefore, the present study will be conducted with objective of evaluation of the efficacy and safety of FCM for treatment of moderate to severe iron deficiency anemia in pregnancy. This is Single center, Retrospective, Observational data collection at real-life scenario. Data of female patients (at baseline and after 4 (±) 2 weeks) who had prior visited to department of Obstetrics and Gynecology for treatment of Iron Deficiency Anemia (IDA) and received ferric carboxymaltose (FCM) injection will be retrieved and analyzed. |