Umbilical Cord Clamping and Infant Iron Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- Hematologic status at 6 months of age
研究概览
简要总结
The aim of the study was to determine whether delayed umbilical cord clamping, as compared to early umbilical cord clamping, improves infant iron status at 6 months of age.
详细描述
In developing countries, up to 50% of children become anemic by 12 months of age. Risk factors for iron deficiency (ID) include low birth weight, maternal prenatal ID, and male sex. Iron deficiency anemia (IDA) during infancy and childhood is of particular concern because of the potentially detrimental effects on development, some of which may be irreversible even after treatment to correct the deficiency. Delayed umbilical cord clamping is an intervention that increases the infant's iron endowment at birth and has been shown to increase hemoglobin (Hgb) concentration at two months of age. We determined whether a two-minute delay in the clamping of the umbilical cord of normal-weight, full-term infants significantly affected infant iron and hematological status through 6 months of age. In addition, we determined whether the effect of delayed cord clamping was significantly enhanced in subgroups of infants at higher risk of developing iron deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women delivering at study site hospital
排除标准
- •Delivery by Cesarean section
- •Pregnancy ≤ 36 or ≥ 42 weeks gestation
- •Multiple gestation
- •Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus
- •Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
- •Diagnosis at any time for the mother of any of the following: Diabetes, hypertension, cardiopathies, chronic renal disease
- •Infant with major congenital malformation
- •Infant birth weight less than 2500 g
- •Mother not planning to breast feed for at least 6 months
- •Mother smoked during current pregnancy
- •Unwilling to return for follow-up study visits at the hospital
结局指标
主要结局
Hematologic status at 6 months of age
Iron status at 6 months of age
次要结局
- Newborn hematocrit at 7 hours of age
- Maternal report of clinical jaundice at 3 and 14 days of age
- Estimated maternal bleeding at delivery