Influence of Umbilical Cord Clamping Time in the Newborn

Pascual Gregori Roig

Status: Completed

Conditions: Hyperbilirubinemia, Neonatal; Anemia Neonatal; Polycythemia Secondary

Treatments: Procedure: Blood Test 48hours; Procedure: DCC; Procedure: Blood Test 24hours; Procedure: Blood Test 6hours; Procedure: ECC; Procedure: Blood Test 28days

Study type: Interventional

Funder types: Other

Identifiers

NCT03624335

CORD STUDY

Details and patient eligibility

About

This study compares two umbilical cord clamping times; the early one, up to a minute (ECC) and the late or delayed one, when the cord stop beating (DCC). The additional blood volume delivered to the newborn from the placenta - placental transference - by delaying umbilical cord ligation, increases the contribution of neonatal iron with increased iron stores in the infant, without increasing neonatal morbidity.

Full description

It is an intervention study without drugs administration with a longitudinal, prospective comparison and correlational design.

Patients are recruited by simple random sampling to one of the two intervention groups:

Group 1-ECC: Early clamping of the umbilical cord (before the first minute of life).

Group 2-DCC: Delayed clamping of the umbilical cord (when it stops beating).

Enrollment: 195 patients

Sex: All

Ages: 35 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• neonates with a gestational age of 35 to 42 weeks and born through normal vaginal delivery.

Exclusion criteria

• monochorionic multiples
• incarcerated mothers
• placenta previa
• concern for abruptions
• Rh sensitization
• hydrops
• congenital anomalies
• the obstetrician declining to perform the intervention

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

Group 1: ECC

Experimental group

Description:

In the ECC group, the cord was clamped immediately after delivery, before the first minute of life. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping

Treatment:

Procedure: Blood Test 24hours

Procedure: Blood Test 6hours

Procedure: ECC

Procedure: Blood Test 28days

Procedure: Blood Test 48hours

Group 2: DCC

Experimental group

Description:

In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping

Treatment:

Procedure: DCC

Procedure: Blood Test 24hours

Procedure: Blood Test 6hours

Procedure: Blood Test 28days

Procedure: Blood Test 48hours