The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Hemoglobin
研究概览
简要总结
The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.
详细描述
Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis.
The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gynecological surgery
- •Hb 5-7 mmol/L
排除标准
- •Pregnancy
- •Oncological operations
- •Infections (PID)
- •Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
- •Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
- •Small vulvar / vaginal operations such as (cysts, labia correction)
- •Endometrial ablation
- •Legal incapacity
- •The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery
- •Hematologic disorders
- •Erythropoiesis-stimulating agents < 3months ago
- •Myelosuppressive therapy in history
- •Hepatitis
- •Alcohol abuses
- •Not understanding Dutch
- •Allergic reaction to iron therapy in past
研究组 & 干预措施
Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
干预措施: Ferinject (Drug)
Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
干预措施: Placebo for ferrous fumarate (Drug)
Ferrous fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
干预措施: Ferrous fumarate (Drug)
Ferrous fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
干预措施: Placebo for ferinject (Drug)
Placebo infusion and tablets
Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery
干预措施: Placebo for ferrous fumarate (Drug)
Placebo infusion and tablets
Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery
干预措施: Placebo for ferinject (Drug)
结局指标
主要结局
Hemoglobin
时间窗: 3 weeks postoperative
Serum hemoglobin level
次要结局
- Serum Hepcidin(3 weeks postoperative)
- Serum Ferritin(3 weeks postoperative)