Placental Transfusion Clinical Trial
Official title:
Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?
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.
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.
In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion
of the umbilical cord at 120 seconds after birth and then a new Weight will be obtained
after clamping.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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