Influence of Umbilical Cord Clamping Time in the Newborn

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624335
• Other study ID #: CORD STUDY
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anemia Neonatal
• Anemia, Neonatal
• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neoplasm Metastasis
• Polycythemia
• Polycythemia Secondary

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