Skip to main content
OpenTrials
Completed

NCT Number: NCT03624335

Influence of Umbilical Cord Clamping Time in the Newborn

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Neonatal Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Polycythemia Secondary

Age range

35 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de La Plana

Villarreal, Castellón, 12540, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECC

Procedure

Early clamping of the umbilical cord

DCC

Procedure

Delayed clamping of the umbilical cord

Blood Test 6hours

Procedure

Blood Test 6hours

Blood Test 24hours

Procedure

Blood Test 24hours

Blood Test 48hours

Procedure

Blood Test 48hours

Blood Test 28days

Procedure

Blood Test 28days

Primary outcomes

  1. haemoglobin

    Time frame: 6hours

    haemoglobin level

  2. haemoglobin

    Time frame: 28 days

    haemoglobin level

  3. haematocrit

    Time frame: 6 hours

    haematocrit level

  4. haematocrit

    Time frame: 28 days

    haematocrit level

Secondary outcomes

  1. serum ferritin

    Time frame: 6hours

    serum ferritin level

  2. serum ferritin

    Time frame: 28days

    serum ferritin level

  3. bilirubin

    Time frame: 6hours

    bilirubin level

  4. bilirubin

    Time frame: 28days

    bilirubin level

Sponsors and collaborators

Lead sponsor

Pascual Gregori Roig

Other

Collaborators

  • FUNDACIÓN DAVALOS FLETCHER
  • Hospital Universitario de la Plana

Registry information

Official study title

Influence of Umbilical Cord Clamping Time in the Newborn, Secondary Neonatal Morbidity and Iron Deposits in the Neonate

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.