Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Maternal postpartum haemorrhage incidence
研究概览
简要总结
Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour. However in recent years, several studies have shown that delayed cord clamping may offer important benefits to the newborn. The data gathered indicate that delayed cord clamping may be particularly useful in premature babies, between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the incidence of intraventricular haemorrhage.
However it is argued that the described potential benefits of delayed cord clamping could be negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by potential interference with the postpartum haemorrhage management, initial care and reanimation of the premature newborn, and the possibility of cord blood donation. These factors, together with as the lack of homogeneity among existing studies regarding the delayed cord clamping technique create the need, in our opinion, for further research, to establish the proper place of this measure.
Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces the need for blood transfusions and intraventricular haemorrhage, compared with usual early cord clamping.
Secondary outcomes:
- To define the impact of delayed cord clamping on neonatal assessment parameters after delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.
- Neonatal mortality and morbidity
- Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage
- To study the correlation between Iron metabolism and reticulocitary haemoglobin levels in cord and infant blood.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Deliveries ( either vaginal or by C-section) between 26 and 32.6 weeks of gestation.
- •Patients must be over 18 years old.
- •Patient understands and signs informed consent.
排除标准
- •Urgent C-section
- •gestational age under 22 or over 33 weeks
- •Major fetal anomalies (requiring surgery or with a high risk of neonatal death or incapacity)
- •Major uterine malformations
- •Placenta previa.
- •Multiple gestations
- •Fetal hydrops
- •Severe Iso- Immunization
- •HIV-positive mother
- •Severe Intrauterine growth restriction ( Reverse atrial Flow in DV)
- •Intrauterus Ventricular haemorrhage
研究组 & 干预措施
early umbilical cord occlusion
Cord clamping will be performed before 30 seconds after delivery, annoting the exact time of clampage and initiating reanimation and postnatal care procedures as usual. 60 second after delivery of the new born, 10 IU of Oxytocin will be administered intramuscularly.
干预措施: early umbilical cord occlusion (Procedure)
early umbilical cord occlusion
Cord clamping will be performed before 30 seconds after delivery, annoting the exact time of clampage and initiating reanimation and postnatal care procedures as usual. 60 second after delivery of the new born, 10 IU of Oxytocin will be administered intramuscularly.
干预措施: Oxytocin (Drug)
delayed umbilical cord occlusion
One of the paediatricians will hold the newborn ( in vaginal deliveries between 20-30 cm under the mother, in C-sections between the legs of the mother) until clamping of the umbilical cord is indicated by a second paediatrician who will be controlling the time and overall state of the baby. The baby will be wrapped during this time in a thermal blanket in a flexed lateral decubitus position to minimise stress and heat loss. Time of clamping: after 30 to 60 seconds( preferably 60). If loss of the baby's wellbeing is suspected, the paediatrician will assess the newborn's heart rate , stopping the procedureif this falls under 100ppm, initiating at that moment the necessary reanimation procedures.
60 second after the delivery of the new born 10 IU of oxytocin will be administered intramuscularly.
干预措施: delayed umbilical cord occlusion (Procedure)
delayed umbilical cord occlusion
One of the paediatricians will hold the newborn ( in vaginal deliveries between 20-30 cm under the mother, in C-sections between the legs of the mother) until clamping of the umbilical cord is indicated by a second paediatrician who will be controlling the time and overall state of the baby. The baby will be wrapped during this time in a thermal blanket in a flexed lateral decubitus position to minimise stress and heat loss. Time of clamping: after 30 to 60 seconds( preferably 60). If loss of the baby's wellbeing is suspected, the paediatrician will assess the newborn's heart rate , stopping the procedureif this falls under 100ppm, initiating at that moment the necessary reanimation procedures.
60 second after the delivery of the new born 10 IU of oxytocin will be administered intramuscularly.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Maternal postpartum haemorrhage incidence
时间窗: within 24 hours after birth
Volume of neonatal red blood cell transfusions
时间窗: for the duration of hospital stay, an expected average of 2 months.
Number of red blood cell transfusions to the newborn
时间窗: for the duration of hospital stay, an expected average of 2 months.
Intraventricular Haemorrhage incidence
时间窗: from delivery, for the duration of hospital stay, an expected average of 2 months.
次要结局
- Neonatal mortality(up to 27 days after birth.)