Influence of Umbilical Cord Clamping Time in the Newborn

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal; Anemia Neonatal; Polycythemia Secondary
• Intervention / Treatment: Procedure: ECC; Procedure: Blood Test 6hours; Procedure: Blood Test 24hours; Procedure: Blood Test 48hours; Procedure: Blood Test 28days; Procedure: DCC

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).

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castellón
    • Villarreal, Castellón, Spain, 12540
      • Hospital Universitario de La Plana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: ECC; 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: ECC; Early clamping of the umbilical cord; Procedure: Blood Test 6hours; Blood Test 6hours; Procedure: Blood Test 24hours; Blood Test 24hours; Procedure: Blood Test 48hours; Blood Test 48hours; Procedure: Blood Test 28days; Blood Test 28days
Experimental: Group 2: DCC; 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: Blood Test 6hours; Blood Test 6hours; Procedure: Blood Test 24hours; Blood Test 24hours; Procedure: Blood Test 48hours; Blood Test 48hours; Procedure: Blood Test 28days; Blood Test 28days; Procedure: DCC; Delayed clamping of the umbilical cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
haemoglobin	haemoglobin level	6hours
haemoglobin	haemoglobin level	28 days
haematocrit	haematocrit level	6 hours
haematocrit	haematocrit level	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum ferritin	serum ferritin level	6hours
serum ferritin	serum ferritin level	28days
bilirubin	bilirubin level	6hours
bilirubin	bilirubin level	28days

Collaborators and Investigators

• Sponsor: Pascual Gregori Roig
• Collaborators: Hospital Universitario de la Plana; FUNDACIÓN DAVALOS FLETCHER
• Investigators: Study Chair: Vanesa Rodenas, PhD, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2015
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): March 31, 2016

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Umbilical cord clamping; Anemia Neonatal; Iron metabolism disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Neoplastic Processes; Neoplasm Metastasis; Anemia, Neonatal; Polycythemia; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: CORD STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Protocol study & Data Analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No