Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change of Temperature After Delayed Umbilical Clamping
研究概览
简要总结
Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. Umbilical cord can be clamped within 30s or at least 1 min after birth. A lot of studies have shown that delayed umbilical cord clamping is associated with greater haemoglobin concentration, better iron storage between 3-6 months of life and lower incidence for transfusion and neonatal hypotension compared to immediate umbilical cord clumping. Newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section.
详细描述
Umbilical cord cutting determines the separation of the newborn from mother. Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. In the spontaneous labor there are two modalities to obtain umbilical cord clamping: the first modality is immediate umbilical cord clamping within 30s from birth. The second modality is delayed umbilical cord clamping at least 1 min after birth. After 1 min, cerebral blood flow is reduced again because of lower cardiac output.
A lot of studies have shown that delayed umbilical cord clamping is better than the early umbilical clamping because delayed umbilical cord clamping is associated with a great haemoglobin concentration in the newborns and best iron storage between 3-6 months of life and less incidence for transfusion and neonatal hypotension. Experimental studies, executed on animals and humans, analysed cardiocirculatory changes in the foetus immediately after birth and the importance of the delayed clamping for the hemodynamic stabilization, particularly in the lowest gestational age.
In a recent randomized study conducted in Nepal on 540 newborns, birth by eutocic delivery with 39.2 weeks of gestational age, showed that delayed umbilical cord clamping after 3 min of life is correlated with a better haemoglobin level and less incidence of anaemia at 8 months of life. Zhou et al. conducted a meta-analysis that included hematologic parameters obtained by umbilical cord, placenta and newborns blood.
Association of Italian Hospital Gynecologists Obstetricians (AOGOI) declared contraindicated conditions to execute a delayed umbilical cord clamping:
Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of fetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest. Monochorionic twins, Fetal Hydrops, Umbilical cord damaged, Isoimmunization Rh.
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
- None
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth Body Weight = appropriate for gestational age
- •Delivery mode= Elective Caesarean Section
- •Mothers' BMI = 19-24,9
- •Mothers'age ≤ 37 years
排除标准
- •Admission in NICU;
- •Neonatal Resuscitation
- •Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of foetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest
- •Pathologies ;
- •Smoking mothers;
- •Assumption of drugs during pregnancy
- •Mother toxicomaniac
结局指标
主要结局
Change of Temperature After Delayed Umbilical Clamping
时间窗: 5 minutes after birth
Temperature change (T)
Change of Saturation After Delayed Umbilical Clamping
时间窗: 5 minutes and 10 minutes after birth
Saturation change (SpO2)
Change of Heart Rate After Delayed Umbilical Clamping
时间窗: 5 minutes and 10 minutes after birth
It will be measured the change of heart rate (HR)
次要结局
- Misuration of the Hematocrit After Delayed Umbilical Clamping(72 hours of life)
- Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping(120 minutes after birth)
- Misuration of the Bilirubin After Delayed Umbilical Clamping(72 hours of life)
研究者
Giuseppe De Bernando
Principal Investigator
Fondazione Poliambulanza Istituto Ospedaliero