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Influence of Umbilical Cord Clamping Time in the Newborn

Primary Purpose

Anemia Neonatal, Polycythemia Secondary, Hyperbilirubinemia, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ECC
DCC
Blood Test 6hours
Blood Test 24hours
Blood Test 48hours
Blood Test 28days
Sponsored by
Pascual Gregori Roig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anemia Neonatal focused on measuring Umbilical cord clamping, Anemia Neonatal, Iron metabolism disorders

Eligibility Criteria

35 Weeks - 42 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Universitario de La Plana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: ECC

Group 2: DCC

Arm Description

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

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

Outcomes

Primary Outcome Measures

haemoglobin
haemoglobin level
haemoglobin
haemoglobin level
haematocrit
haematocrit level
haematocrit
haematocrit level

Secondary Outcome Measures

serum ferritin
serum ferritin level
serum ferritin
serum ferritin level
bilirubin
bilirubin level
bilirubin
bilirubin level

Full Information

First Posted
August 2, 2018
Last Updated
August 8, 2018
Sponsor
Pascual Gregori Roig
Collaborators
Hospital Universitario de la Plana, FUNDACIÓN DAVALOS FLETCHER
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1. Study Identification

Unique Protocol Identification Number
NCT03624335
Brief Title
Influence of Umbilical Cord Clamping Time in the Newborn
Official Title
Influence of Umbilical Cord Clamping Time in the Newborn, Secondary Neonatal Morbidity and Iron Deposits in the Neonate
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 23, 2015 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
March 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pascual Gregori Roig
Collaborators
Hospital Universitario de la Plana, FUNDACIÓN DAVALOS FLETCHER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia Neonatal, Polycythemia Secondary, Hyperbilirubinemia, Neonatal
Keywords
Umbilical cord clamping, Anemia Neonatal, Iron metabolism disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trials comparing early and late cord clamping
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: ECC
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2: DCC
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
ECC
Intervention Description
Early clamping of the umbilical cord
Intervention Type
Procedure
Intervention Name(s)
DCC
Intervention Description
Delayed clamping of the umbilical cord
Intervention Type
Procedure
Intervention Name(s)
Blood Test 6hours
Intervention Description
Blood Test 6hours
Intervention Type
Procedure
Intervention Name(s)
Blood Test 24hours
Intervention Description
Blood Test 24hours
Intervention Type
Procedure
Intervention Name(s)
Blood Test 48hours
Intervention Description
Blood Test 48hours
Intervention Type
Procedure
Intervention Name(s)
Blood Test 28days
Intervention Description
Blood Test 28days
Primary Outcome Measure Information:
Title
haemoglobin
Description
haemoglobin level
Time Frame
6hours
Title
haemoglobin
Description
haemoglobin level
Time Frame
28 days
Title
haematocrit
Description
haematocrit level
Time Frame
6 hours
Title
haematocrit
Description
haematocrit level
Time Frame
28 days
Secondary Outcome Measure Information:
Title
serum ferritin
Description
serum ferritin level
Time Frame
6hours
Title
serum ferritin
Description
serum ferritin level
Time Frame
28days
Title
bilirubin
Description
bilirubin level
Time Frame
6hours
Title
bilirubin
Description
bilirubin level
Time Frame
28days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 hydrops congenital anomalies the obstetrician declining to perform the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanesa Rodenas, PhD
Organizational Affiliation
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario de La Plana
City
Villarreal
State/Province
Castellón
ZIP/Postal Code
12540
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Protocol study & Data Analysis
Citations:
PubMed Identifier
36126369
Citation
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.
Results Reference
derived

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Influence of Umbilical Cord Clamping Time in the Newborn

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