Influence of Umbilical Cord Clamping Time in the Newborn

Not Applicable

Completed

• Conditions: Anemia Neonatal; Polycythemia Secondary; Hyperbilirubinemia, Neonatal
• Interventions: Procedure: DCC; Procedure: ECC; Procedure: Blood Test 6hours; Procedure: Blood Test 24hours; Procedure: Blood Test 48hours; Procedure: Blood Test 28days

• Registration Number: NCT03624335
• Lead Sponsor: Pascual Gregori Roig

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2015-03-23
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Status Verified: 2018-08
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-10
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: DCC	DCC	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
Group 2: DCC	Blood Test 24hours	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
Group 1: ECC	ECC	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
Group 2: DCC	Blood Test 6hours	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
Group 2: DCC	Blood Test 28days	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
Group 1: ECC	Blood Test 6hours	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
Group 1: ECC	Blood Test 48hours	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
Group 1: ECC	Blood Test 24hours	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
Group 1: ECC	Blood Test 28days	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
Group 2: DCC	Blood Test 48hours	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

Primary Outcome Measures

Name	Time	Method
haemoglobin	28 days	haemoglobin level
haematocrit	28 days	haematocrit level

Secondary Outcome Measures

Name	Time	Method
serum ferritin	28days	serum ferritin level
bilirubin	28days	bilirubin level

Trial Locations

Locations (1)

Hospital Universitario de La Plana; 🇪🇸 Villarreal, Castellón, Spain