NCT01487980已完成不适用
The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Haemoglobin level
研究概览
简要总结
Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment.
排除标准
- •twin pregnancy
- •history of postpartum haemorrhage (PPH)
- •(gestational) diabetes
- •pre-eclampsia
- •abruptio placentae
- •caesarian section
- •necessity of early clamping due to tight nuchal cord
- •need for resuscitation immediately after birth
- •major congenital abnormalities
结局指标
主要结局
Haemoglobin level
时间窗: two months
次要结局
- Hyperviscosity syndrome(1 day)
- Iron status(two months)
- hyperbilirubinaemia(2 days)
研究者
S. Tiemersma
Medical Officer
Stanger Hospital
研究点 (2)
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