Implementation research to explore operational feasibility, acceptability and cost-effectiveness of using IVFerric Carboxy Maltose (FCM) in Management of Iron Deficiency Anemia (IDA) among pregnant women through sub district health systemin Maharashtra
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- 4.Need for blood transfusions
研究概览
简要总结
The study is focusing on a very important public health problem “Anemia in Pregnancyâ€. Very recently IV Sucrose was tested for its efficacy among anemic pregnant women1 which showed no difference in pregnancy outcomes due to use of injectable vs oral iron. Till date IV Iron sucrose is the most commonly used injectable iron preparation for treatment of iron deficiency anemia. However use of this iron sucrose mandates the patient to visit the health facility three times on alternate day .This study intends to test the new compound Ferric Carboxy Maltose (FCM) for managing anemia in pregnancy which is given in a bolus single dose and equally efficacious with no adverse effects . A single dose of FCM may have better compliance than multiple doses with IV Iron Sucrose. Although Poshan Abhiyan has suggested this drug in the guidelines, State health department of Maharashtra has not officially introduced it in program at all levels of health care. Hence this study will generate evidence to facilitate program decision making and strengthen the management strategy within district health system.
a]Pregnant women registered for ANC & diagnosed with moderate IDA between 22weeks-32 weeks [after trying standard oral iron] OR diagnosed with severe anemia between 22 weeks to 32 weeks of pregnancy]
b]Not responding to oral iron therapy
c]Enroll for parenteral iron randomly assigned to either IV FCM or IV Iron sucrose
d]Follow up after 4 weeks to check improvement in blood indices
e]Follow-up 6 weeks after delivery to document pregnancy and neonatal
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosed with iron deficiency anemia with hemoglobin levels between 5- 9.9gm/dl between 22-32 weeks of gestational age with following criteria Severe anemia with hemoglobin <7 gms anytime between 22-32 weeks Moderate anemia with hemoglobin between 7-9.9 gms during 22-28 weeks not responding to oral iron given for 6 weeks Moderate anemia in last trimester irrespective of previous iron intake.
- •Willing to sign an informed consent, deliver at the same site and willing for follow up.
排除标准
- •â€¢Pregnant women with hemoglobin levels below 5gm/dl and above 9.9 gm/dl in the first or second trimester of pregnancy.
- •â€¢Pregnant women diagnosed with anemia other than iron deficiency anemia based on peripheral smear examination and red cell indices, picture suggestive of pancytopenia, •Any known cases of hemoglobinopathies or with Pregnancy Induced Hypertension • History of iron overload disorder (Thalassemia, hemochromatosis, hemosiderosis] •Pregnant women with known cardiac, renal, hepatic disease •Pregnant women having associated medical disorders like hypertension, asthma, tuberculosis, heart disease rheumatic or congenital heart disease), heart failure or cardiac decompensation, •history of intravenous iron therapy in the past 6 months or history of repeated blood transfusions •Pregnant women with known OR history of hypersensitivity to ferric carboxy-maltose or iron sucrose •Pregnant women in labor •Blood loss due to hemodynamic instability •History of malignancy, GI bleed, surgery •suspected acute infections (such as upper respiratory tract infections, urinary tract infections, or fever at the time of visit), h/o of rashes and fever during pregnancy to rule rubella).
结局指标
主要结局
4.Need for blood transfusions
时间窗: 1.4weeks 2.6months
5.Anemia in mother post-partum at 6 weeks
时间窗: 1.4weeks 2.6months
6.Type of delivery and indications
时间窗: 1.4weeks 2.6months
1.Change in Hb, Ferritin, transferrin saturation
时间窗: 1.4weeks 2.6months
2.Adverse events during IV iron administration
时间窗: 1.4weeks 2.6months
3.Compliance to treatment
时间窗: 1.4weeks 2.6months
7.Complications during delivery – PPH, puerperal sepsis, shock etc
时间窗: 1.4weeks 2.6months
8.Live births, still births
时间窗: 1.4weeks 2.6months
9.Birth weight
时间窗: 1.4weeks 2.6months
10.Prolonged hospital stay
时间窗: 1.4weeks 2.6months
11.Need for admission in intensive care unit
时间窗: 1.4weeks 2.6months
次要结局
- Feasibility and acceptability(Costs and Quality of lIfe)