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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8,040
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •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).
排除标准
- •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).
结局指标
主要结局
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.
时间窗: 9 months
次要结局
- Individual, societal, contextual, and programmatic views on the acceptability and uptake of injectable iron preparations and programmatic readiness for injectable iron preparations.(3 months)