Placental Transfusion and Cord Clamping

Fundacion para la Salud Materno Infantil

Status: Completed

Conditions: Placental Transfusion

Treatments: Procedure: position at Maternal Abdomen; Procedure: Position at introitus level

Study type: Interventional

Funder types: Other

Identifiers

NCT01497353

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Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 patients

Sex: All

Ages: Under 2 minutes old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Term newborns
• vigorous born by vaginal delivery
• informed consent Signed.

Exclusion criteria

• 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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Position at introitus level

Active Comparator group

Description:

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.

Treatment:

Procedure: Position at introitus level

Position at Maternal Abdomen

Experimental group

Description:

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 .

Treatment:

Procedure: position at Maternal Abdomen