NCT01497353

Placental Transfusion and Cord Clamping

Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Fundacion para la Salud Materno Infantil · Academic / Other
• Sex: All
• Age: 2 Minutes
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Placental Transfusion

Interventions

Type	Name	Description
PROCEDURE	Position at introitus level	After birth: Weigh at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec then another Weigh will be obtained after clamping
PROCEDURE	position at Maternal Abdomen	After birth: Weight at 10 + 2 sec then the baby will be placed at maternal abdomen and Cord clamping will be performed at 120 sec and new Weigh will be obtained after clamping

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2011-12-22
• Last updated: 2012-10-19

Locations

3 sites across 1 country: Argentina