Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth? a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 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
Pilot study. Randomized controlled trial not blind, in one center. 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 with cord clamping at 2 minutes after birth. Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level).
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.
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, cephalic or vertex presentation.
- •Signed informed consent.
排除标准
- •History of Placenta previa,
- •postpartum hemorrhage background, hemorrhage before 20- week- gestation.
- •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 .
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 peripherical hematocrit and bilirubin values between the 2 groups .(36-48 hs)