Skip to content

FCM IV iron introduction in Bihar - Implementation research

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059661
Enrollment
8040
Registered
2023-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D50- Iron deficiency anemia

Interventions

Intervention1: 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

Sponsors

Bill & Melinda Gates Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 9 months

Secondary

MeasureTime frame
Individual, societal, contextual, and programmatic views on the acceptability and uptake of injectable iron preparations and programmatic readiness for injectable iron preparations.Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Pragya Kumar

AIIMS Patna

pragyasinha2002@gmail.com9471000734

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026