The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Haemoglobin level
研究概览
简要总结
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency.
详细描述
Background of the study:
Iron deficiency anaemia in pregnancy is common and the standard treatment is iron supplementation once or twice daily. But there is no evidence for the optimal dose of iron supplementation in pregnancy. In non-pregnant women intermittent oral iron supplementation on alternate days is proven to have a similar effect on haemoglobin levels as iron supplementation daily with less side effects. In pregnancy the need and absorption of iron is physiologically higher. Therefore the optimal dose may differ from non-pregnant women.
The adverse effects of iron supplementation, which are mainly gastrointestinal effects, seem to be related to the dose of iron supplementation. These effects often already exist physiologically in pregnancy and may increase with the use of iron supplementation. Therefore, a lower dose would be preferable in pregnancy if the effectiveness is similar.
In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency. Our hypothesis is that intermittent oral iron supplementation is at least as effective as iron supplementation once daily and will give less adverse effects.
Objective of the study:
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
- None
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
- •Pregnant women of 18 years and older
- •Iron deficiency anaemia (defined as: Anaemia (haemoglobin lower than cut-off value) AND mean corpuscular volume (MCV) 70-85 fl OR ferritin <30ug/L) OR mean corpuscular volume (MCV) < 70fl / hemoglobinopathy is ruled out.
- •Adequate mental health
- •Good command of the Dutch language
- •No participation in other research with medication
- •Informed consent
排除标准
- •Start of iron supplementation at pregnancy duration > 37 weeks (because of the limited time to achieve an increase in haemoglobin).
- •History of bariatric surgery, inflammatory bowel disease, coeliac disease or Helicobacter pylori infection (because of malabsorption of iron).
- •Patients who received blood transfusion or parental iron supplementation during the 3 months prior to screening (because of the effect on the haemoglobin level).
- •Patients with significant bleeding, blood donation or surgery during pregnancy (because of the effect on the haemoglobin level).
- •Allergy for iron.
- •Anaemia of other cause, such as a hemoglobinopathy.
研究组 & 干预措施
Intermittent
This group will receive ferrous fumarate 200mg intermittent three times a week on alternate days.
干预措施: Ferrous fumarate (Drug)
Daily
This group will receive ferrous fumarate 200mg once daily.
干预措施: Ferrous fumarate (Drug)
结局指标
主要结局
Haemoglobin level
时间窗: 6 weeks after start treatment
The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable.
次要结局
- Side effects(6 weeks after start treatment)
- Haemoglobin level at time of delivery(At time of delivery)
- Birth weight(At delivery)
- Parenteral iron ante- or postpartum(From start treatment until 1 week after delivery)
- Therapy compliance(6 weeks after start treatment)
- Term of delivery(At delivery)
- Blood transfusion postpartum(Until 1 week after delivery)
研究者
Maryse de Graaf
drs
Martini Hospital Groningen