FCM IV iron introduction in Bihar - Implementation research

Not yet recruiting

Brief Summary: The proposed study aims toaddress the pressing issue of anemia in pregnant and postpartum women in Bihar,India, where a significant proportion of women suffer from this condition. Theexisting system relies on oral iron supplementation and limited intravenoussucrose treatment, but there is a need to explore the feasibility andacceptability of intravenous ferric carboxymaltose (FCM) for treating anemia.

The study will be conductedin selected health facilities across five districts in Bihar, with a mixed-methodapproach. Qualitative research will investigate perspectives of end-users,healthcare providers, and program managers on the acceptability and feasibilityof injectable IV iron preparation. Quantitative research will focus onidentifying the best operational pathway for administering IV FCM and measuringthe 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. Thisresearch seeks to improve the management of anemia in pregnant and postpartumwomen, ultimately benefiting maternal and child health in Bihar.

Recruitment & Eligibility

Inclusion Criteria

1.Pregnant women with a Hb level of 5â€“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 5â€“8.9 g/dL (moderate/severe anaemia).
3.Ratio of MCV to RBC count â‰¥13(Iron deficiency anaemia).

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).

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Individual, societal, contextual, and programmatic views on the acceptability and uptake of injectable iron preparations and programmatic readiness for injectable iron preparations.	3 months

Locations (1): All India Institute of Medical Sciences Patna
🇮🇳
Patna, BIHAR, India
All India Institute of Medical Sciences Patna
🇮🇳Patna, BIHAR, India
Dr Pragya Kumar
Principal investigator
9471000734
pragyasinha2002@gmail.com