Efficacy and Safety of Ferric Carboxymaltose Injection in Pregnant women:Retrospective analysis at Indian Real-life Scenario
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean change in hemoglobin level from baseline to week 4 (± 2)
研究概览
简要总结
Iron Deficiency Anemia (IDA) is prevalent in Indian pregnant women; around 47% of women suffer from anemia during pregnancy. If IDA remains untreated during pregnancy it can cause perinatal mortality as well as maternal mortality. Therapy for ID includes mainly dietary modification, oral iron supplementation and some cases intravenous iron and blood transfusion. Oral iron therapy is mainstay in treating IDA in pregnancy but it also has associated gastrointestinal side effects. Oral iron therapy is not adequate to treat moderate to severe anemia in the late second and third trimester. Parenteral iron therapy is the treatment of choice in this condition.
FCM is an attractive alternative to iron sucrose complex (ISC) in terms of safety, efficacy, convenience, and resource utilization. Very little literature is available on the use of FCM in pregnancy and there are limited prospective studies on FCM in pregnancy also. Therefore, the present study will be conducted with objective of evaluation of the efficacy and safety of FCM for treatment of moderate to severe iron deficiency anemia in pregnancy.
This is Single center, Retrospective, Observational data collection at real-life scenario. Data of female patients (at baseline and after 4 (±) 2 weeks) who had prior visited to department of Obstetrics and Gynecology for treatment of Iron Deficiency Anemia (IDA) and received ferric carboxymaltose (FCM) injection will be retrieved and analyzed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant female patients aged more than 18 years of age who visited to department of Obstetrics and Gynecology in their 2nd and 3rd trimester of gestation.
- •Documented Iron deficiency anemia and received FCM injection.
- •Data for hematological parameters (hemoglobin, serum ferritin) are available at baseline and for minimum at 4 ± 2 weeks.
- •Patients already provided informed consent for future use of their medical records for research.
排除标准
- •Any other type of anemia apart from Iron Deficiency anemia
- •Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis).
- •Any malignancy.
- •Presence of active liver disease/ HBV or HCV infection, CKD, HIV infection / AIDS, asthma, or rheumatoid arthritis.
结局指标
主要结局
Mean change in hemoglobin level from baseline to week 4 (± 2)
时间窗: Baseline to week 4 (± 2)
次要结局
- 1. Change in serum ferritin levels(2. Change in hematological parameters (PCV, MCV, MCH, MCHC) if available)