EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCY
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Blood Haemoglobin Levels
研究概览
简要总结
This study was planned to compare outcomes of IV versus oral iron in the treatment of iron deficiency anemia during pregnancy. This study was used to investigate the efficacy of two new formulations of iron both in IV and oral form with fewer side effects. We compared the efficacy of Intravenous Ferric Carboxymaltose with Oral polysaccharide iron complex. The better mode of treatment will be administered in future to treat this condition, that will surely improve the fetal and maternal outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 18 -45 years;
- •Second trimester (gestational age 14-21 weeks);
- •Females having hemoglobin level of < 11 g/dL
排除标准
- •Multiple pregnancies,
- •A history of multiple allergies, known hypersensitivity to any of the excipients in the investigational drugs,
- •Active infections
- •Recent red blood cell (RBC) transfusion
- •Thalassemia minor
研究组 & 干预措施
Group A participants who were administered Intravenous Iron supplementation (Ferric carboxymaltose )
Treatment was initiated at the baseline visit. After baseline data was collected, women allocated to the IV iron group received a single dose of 500 mg Ferric carboxymaltose diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight is < 50 kg the dose was 10 mg/kg based on pre-pregnancy body weight). Infusions were administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma.
干预措施: Iron Carboxymaltose (Drug)
Group B participants who were administered Oral Iron Supplementation (polysaccharide iron complex)
Women in the oral iron group received polysaccharide iron complex 150 mg capsule till 4 weeks. All randomized participants had scheduled follow-ups and outcome was assessed as per operational definition at 4th weeks. All data was collected on proforma.
干预措施: Iron Polymaltose Complex (Drug)
结局指标
主要结局
Blood Haemoglobin Levels
时间窗: 4 weeks
Non Anaemic Levels are labelled as (Hb ≥ 11.0 g/dL) at 4th week
次要结局
未报告次要终点
研究者
Dr Salaha Azam
Principal Investigator
Doctors Hospital and Medical Centre Lahore