Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen.
研究概览
简要总结
To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.
详细描述
No inferiority, Randomized controlled trial not blind, Multicenter. Informed consent will be obtained during pregnancy or admittance and previous to birth.
Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus
Term newborns by vaginal delivery and without complications will be included. Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to.
In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight.
Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement.
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
- — 至 2 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term newborns
- •vigorous born by vaginal delivery
- •informed consent Signed.
排除标准
- •History of Placenta previa,
- •postpartum hemorrhage background,
- •Multiple gestation.
- •Background of IUGR prenatally diagnosed.
- •Major congenital malformations diagnosed previous to delivery.
- •Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
- •Extraction of blood sample for bank of umbilical cord stem cells.
- •Elimination criteria:
- •Need for immediate assistance of the newborn,
- •Birth weight less than 2500 g,
- •Nuchal cord wrapped too tight,
- •Major congenital malformations not diagnosed during prenatal period,
- •Delivery surgically finished Short umbilical cord which might prevent placing the infant in the assigned place .
研究组 & 干预措施
Position at introitus level
The newborn will be held by the neonatologist at the level of the introitus, the cord will be clamped at 2 minutes after birth. New weigh will be obtained after that.
干预措施: Position at introitus level (Procedure)
Position at Maternal Abdomen
The newborn will be placed on the abdomen and of the mother immediately after the first weigh measurement. The cord will be clamped at 2 minutes after birth .
干预措施: position at Maternal Abdomen (Procedure)
结局指标
主要结局
Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen.
时间窗: inmediately after birth until 2 minutes after birth
Every elegible and randomiced newborn will be Immediately after birth placed on a scale at the level of the introitus, and the infant's weight will be recorded at 10± 2 sec. Group 1: The infant will be held by the neonatologist at introitus level. The cord will be clamped at 120 seconds after birth. Group 2: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement. The cord will be clamped at 120 seconds after birth. Both groups will be weigth after the cord clamping.
次要结局
- To compare venous hematocrit and bilirubin values between the 2 groups.(36-48 hs)