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Clinical Trials/NCT03624335
NCT03624335
Completed
Not Applicable

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

Pascual Gregori Roig1 site in 1 country195 target enrollmentMarch 23, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia Neonatal
Sponsor
Pascual Gregori Roig
Enrollment
195
Locations
1
Primary Endpoint
haemoglobin
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 23, 2015
End Date
March 31, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pascual Gregori Roig
Responsible Party
Sponsor Investigator
Principal Investigator

Pascual Gregori Roig

Adjunct Pediatrician of University Hospital of La Plana (Spain)

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Eligibility Criteria

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
  • congenital anomalies
  • the obstetrician declining to perform the intervention

Outcomes

Primary Outcomes

haemoglobin

Time Frame: 28 days

haemoglobin level

haematocrit

Time Frame: 28 days

haematocrit level

Secondary Outcomes

  • serum ferritin(28days)
  • bilirubin(28days)

Study Sites (1)

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