| CTRI Number |
CTRI/2023/11/059661 [Registered on: 08/11/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
FCM IV iron introduction in Bihar - Implementation research |
|
Scientific Title of Study
|
Effectiveness, acceptability, feasibility, and mapping of the operational pathway for administration of single dose intravenous ferrous carboxymaltose in moderate-to-severely anemic pregnant and immediate postpartum women in selected districts of Bihar |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragya Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Community & Family medicine, All India Institute of Medical Sciences, Phulwarisharif ,Patna(Bihar)
Phulwarisharif, Patna(Bihar)
Patna
BIHAR
801507
India |
| Phone |
9471000734 |
| Fax |
|
| Email |
pragyasinha2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Community & Family medicine, All India Institute of Medical Sciences, Phulwarisharif ,Patna(Bihar)
Phulwarisharif, Patna(Bihar)
Patna
BIHAR
801507
India |
| Phone |
9471000734 |
| Fax |
|
| Email |
pragyasinha2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Community & Family medicine, All India Institute of Medical Sciences, Phulwarisharif ,Patna(Bihar)
Phulwarisharif, Patna(Bihar)
Patna
BIHAR
801507
India |
| Phone |
9471000734 |
| Fax |
|
| Email |
pragyasinha2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna |
|
|
Primary Sponsor
|
| Name |
Bill & Melinda Gates Foundation |
| Address |
Bill & Melinda Gates Foundation, Seattle Washington, United States |
| Type of Sponsor |
Other [Non-operating private foundation] |
|
|
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 Pragya Kumar |
All India Institute of Medical Sciences Patna |
Room no. 125, Department of Community & Family medicine, All India Institute of Medical Sciences Phulwarisharif ,Patna(Bihar)
Patna
BIHAR |
9471000734
pragyasinha2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Single dose IV FCM in Moderate and Severe anemic Pregnant women |
Ferric Carboxy-maltose (FCM) administration
The dosing chart (table number) has been prepared taking various values of weight and Hemoglobin. It has been decided to administer 1000 mg of FCM to most women except in women weighing less than 55 kg or hemoglobin level more than 9 mg% (to be decided by the medical officer)
FCM will be administered as a slow intravenous infusion over 15 minutes in 250 ml of 0.9% normal saline. A dosing chart will be provided at all sites for this purpose for ease. Research staff shall also use the suggested online calculator to reconfirm the final dose. The required dose of FCM will be administered by a trained ANM under the supervision of a physician. All lifesaving equipment will be available to deal with any unexpected severe adverse reaction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women with a Hb level of 5–8.9 g/dL (moderate/severe anaemia) coming to the facility between gestational age of 15-34 weeks will be considered for FCM administration.
2.Immediate postnatal women with Hb level of 5–8.9 g/dL (moderate/severe anaemia).
3.Ratio of MCV to RBC count ≥13(Iron deficiency anaemia) |
|
| ExclusionCriteria |
| Details |
1.Have previously shown features of congestive heart failure (CHF) on the basis of history.
2.Known to be allergic to iron formulations. (From history)
3.Received any form of parenteral iron or blood transfusion during the current pregnancy. (from history)
4.Reported suffering from any chronic/systemic illness or blood disorders.
5.Postnatal women who took single dose IV FCM during her antenatal period. (from history and line list) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of various points and person responsible for maintaining the pathway of single dose IV iron administration, validation of the Mentzer index as a surrogate indicator of serum ferritin for single-dose IV iron administration in resource-limited settings and identification of factors influencing the rise of hemoglobin after administration of a single dose of IV FCM. This will aid in the most efficient use of scarce resources. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Individual, societal, contextual, and programmatic views on the acceptability and uptake of injectable iron preparations and programmatic readiness for injectable iron preparations. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="8040"
Sample Size from India="8040"
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)
|
17/11/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The proposed study aims to
address the pressing issue of anemia in pregnant and postpartum women in Bihar,
India, where a significant proportion of women suffer from this condition. The
existing system relies on oral iron supplementation and limited intravenous
sucrose treatment, but there is a need to explore the feasibility and
acceptability of intravenous ferric carboxymaltose (FCM) for treating anemia.
The study will be conducted
in selected health facilities across five districts in Bihar, with a mixed-method
approach. Qualitative research will investigate perspectives of end-users,
healthcare providers, and program managers on the acceptability and feasibility
of injectable IV iron preparation. Quantitative research will focus on
identifying the best operational pathway for administering IV FCM and measuring
the impact of sociodemographic factors on hemoglobin improvement.
Expected outcomes include insights into acceptability, program readiness,
and the identification of influencing factors for IV iron administration. This
research seeks to improve the management of anemia in pregnant and postpartum
women, ultimately benefiting maternal and child health in Bihar. |