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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03624335
Other study ID # CORD STUDY
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 23, 2015
Est. completion date March 31, 2016

Study information

Verified date August 2018
Source Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date March 31, 2016
Est. primary completion date March 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Weeks to 42 Weeks
Eligibility 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


Intervention

Procedure:
ECC
Early clamping of the umbilical cord
DCC
Delayed clamping of the umbilical cord
Blood Test 6hours
Blood Test 6hours
Blood Test 24hours
Blood Test 24hours
Blood Test 48hours
Blood Test 48hours
Blood Test 28days
Blood Test 28days

Locations

Country Name City State
Spain Hospital Universitario de La Plana Villarreal Castellón

Sponsors (3)

Lead Sponsor Collaborator
Pascual Gregori Roig FUNDACIÓN DAVALOS FLETCHER, Hospital Universitario de la Plana

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary haemoglobin haemoglobin level 6hours
Primary haemoglobin haemoglobin level 28 days
Primary haematocrit haematocrit level 6 hours
Primary haematocrit haematocrit level 28 days
Secondary serum ferritin serum ferritin level 6hours
Secondary serum ferritin serum ferritin level 28days
Secondary bilirubin bilirubin level 6hours
Secondary bilirubin bilirubin level 28days
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