Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 484
- 试验地点
- 2
- 主要终点
- Change in infant's serum ferritin (μg/L)
研究概览
简要总结
This study aims to determine whether umbilical cord milking can improve iron related health outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord milking, while the other half will receive routine clinical treatment and care.
详细描述
In recent years, several professional organizations have recommended delayed cord clamping to improve placental transfusion for newborns born vaginally based on a series of randomized controlled studies. However, no similar recommendations are available for cesarean-delivered infants. Investigators found that cesarean-delivered infants were more vulnerable to iron deficiency and anemia compared with those born vaginally, suggesting that it is urgently needed to find a similar anemia prevention strategy for infants born by cesarean sections.
In this study, investigators aim to test whether umbilical cord milking (UCM), a potentially promising strategy for cesarean delivery, can improve iron related health outcomes for cesarean-delivered infants. A total of 450 term pregnant women who are planning to give births by cesarean sections will be enrolled from two hospitals in Hunan province and randomly assigned to either UCM group or control group. Infants will be followed up at 1, 6, 12, 18 months for the evaluation of the impact of UCM on iron deficiency, anemia, as well as growth and the developmental status of language and mental/behavioral outcomes.
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
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Full-term pregnancy (no less than 37 gestational weeks)
- •Cesarean section before the labor starts or cesarean section after the labor starts but with cervix less than 3 cm
- •Plan to take vaccines and receive routine child health care in the hospital where she gives birth
排除标准
- •Maternal hypertensive disorder
- •Gestational diabetes with macrosomia
- •Gestational diabetes with polyhydramnios
- •Maternal severe anemia with hemoglobin less than 70 g/L
- •Maternal coagulation disorders
- •Fetal growth restriction
- •Major congenital anomalies
- •Hemolytic disease of the newborn or hydrops fetalis
- •Short umbilical cord length (< 30 cm)
- •Severe cord or placenta abnormalities such as cord prolapse, true knots, placental abruption and placenta previa
- •Other conditions that are not suitable for the study judged by the doctors
研究组 & 干预措施
Umbilical cord milking
The cord will be cut at 25 cm from the umbilical stump within 30 seconds after the infant is taken out from the uterus and its blood will be milked to the infant gently and thoroughly in 30 seconds during resuscitation on the radiant warmer, and then the cord will be cut at 2 to 3 cm from the umbilical stump.
干预措施: Umbilical cord milking (Procedure)
Routine clinical treatment and care
The cord will be dealt with routine clinical method, which means it will be cut twice within 1minute after the infant is taken out from the uterus, the first cut is on the operating table, while the second cut is on the radiant warmer.
结局指标
主要结局
Change in infant's serum ferritin (μg/L)
时间窗: At birth (baseline), 6 and 12 months after birth
At birth (baseline)-2 ml umbilical cord blood, 6 and 12 months old-2 ml infant's venous blood for each measure.
次要结局
- Change in infant's hemoglobin concentration (g/L)(At birth (baseline), 1, 6 and 12 months after birth)
- Number of infants with neonatal jaundice in the experimental group and the control group(Up to 18 months old)
- Number of infants with polycythemia in the experimental group and the control group(Up to 18 months old)
- Change in infant's erythrocyte counts (10^12/L)(At birth (baseline), 1, 6 and 12 months after birth)
- Change in infant's weight (kg)(At birth (baseline), 1, 6, 12 and 18 months after birth)
- Change in infant's transcutaneous bilirubin concentration (mg/dL)(1 (baseline), 2, 3, 4 and 5 days after birth)
- Infant's language development(18 months old)
- Infant's mental/behavioral development(18 months old)
- Change in infant's hematocrit (%)(At birth (baseline), 1, 6 and 12 months after birth)
- Change in infant's height (cm)(At birth (baseline), 1, 6, 12 and 18 months after birth)
研究者
Jianmeng Liu
Professor in Epidemiology and Biostatistics; Director of Institute of Reproductive and Child Health, Peking University; Director of Office for National Maternal and Child Health Statistics of China
Peking University