NCT03624335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 2, 2018

Last Update Submit

August 8, 2018

Conditions

Anemia NeonatalPolycythemia SecondaryHyperbilirubinemia, Neonatal

Keywords

Umbilical cord clampingAnemia NeonatalIron metabolism disorders

Outcome Measures

Primary Outcomes (4)

  • haemoglobin

    haemoglobin level

    6hours

  • haemoglobin

    haemoglobin level

    28 days

  • haematocrit

    haematocrit level

    6 hours

  • haematocrit

    haematocrit level

    28 days

Secondary Outcomes (4)

  • serum ferritin

    6hours

  • serum ferritin

    28days

  • bilirubin

    6hours

  • bilirubin

    28days

Study Arms (2)

Group 1: ECC

EXPERIMENTAL

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

Procedure: ECCProcedure: Blood Test 6hoursProcedure: Blood Test 24hoursProcedure: Blood Test 48hoursProcedure: Blood Test 28days

Group 2: DCC

EXPERIMENTAL

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

Procedure: DCCProcedure: Blood Test 6hoursProcedure: Blood Test 24hoursProcedure: Blood Test 48hoursProcedure: Blood Test 28days

Interventions

ECCPROCEDURE

Early clamping of the umbilical cord

Group 1: ECC
DCCPROCEDURE

Delayed clamping of the umbilical cord

Group 2: DCC
Blood Test 6hoursPROCEDURE

Blood Test 6hours

Group 1: ECCGroup 2: DCC
Blood Test 24hoursPROCEDURE

Blood Test 24hours

Group 1: ECCGroup 2: DCC
Blood Test 48hoursPROCEDURE

Blood Test 48hours

Group 1: ECCGroup 2: DCC
Blood Test 28daysPROCEDURE

Blood Test 28days

Group 1: ECCGroup 2: DCC

Eligibility Criteria

Age35 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- neonates with a gestational age of 35 to 42 weeks and born through normal vaginal delivery.

You may not qualify if:

  • monochorionic multiples
  • incarcerated mothers
  • placenta previa
  • concern for abruptions
  • Rh sensitization
  • hydrops
  • congenital anomalies
  • the obstetrician declining to perform the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de La Plana

Villarreal, Castellón, 12540, Spain

Location

Related Publications (1)

  • Orenga-Orenga BJ, Gregori-Roig P, Real-Fernandez A, Donat-Colomer F, Sanchez-Thevenet P. Umbilical cord clamping time and maternal satisfaction. Midwifery. 2022 Dec;115:103487. doi: 10.1016/j.midw.2022.103487. Epub 2022 Sep 13.

    PMID: 36126369DERIVED

MeSH Terms

Conditions

Anemia, NeonatalHyperbilirubinemia, NeonatalIron Metabolism Disorders

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Vanesa Rodenas, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomised controlled trials comparing early and late cord clamping
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Adjunct Pediatrician of University Hospital of La Plana (Spain)

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 10, 2018

Study Start

March 23, 2015

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

ES(1)