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Influence of Umbilical Cord Clamping Time in the Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624335
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Hospital Universitario de la Plana
FUNDACIÓN DAVALOS FLETCHER
Information provided by (Responsible Party):
Pascual Gregori Roig, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Condition or disease Intervention/treatment Phase
Anemia Neonatal Polycythemia Secondary Hyperbilirubinemia, Neonatal Procedure: ECC Procedure: DCC Procedure: Blood Test 6hours Procedure: Blood Test 24hours Procedure: Blood Test 48hours Procedure: Blood Test 28days Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trials comparing early and late cord clamping
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Umbilical Cord Clamping Time in the Newborn, Secondary Neonatal Morbidity and Iron Deposits in the Neonate
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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: DCC
Delayed 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




Primary Outcome Measures :
  1. haemoglobin [ Time Frame: 6hours ]
    haemoglobin level

  2. haemoglobin [ Time Frame: 28 days ]
    haemoglobin level

  3. haematocrit [ Time Frame: 6 hours ]
    haematocrit level

  4. haematocrit [ Time Frame: 28 days ]
    haematocrit level


Secondary Outcome Measures :
  1. serum ferritin [ Time Frame: 6hours ]
    serum ferritin level

  2. serum ferritin [ Time Frame: 28days ]
    serum ferritin level

  3. bilirubin [ Time Frame: 6hours ]
    bilirubin level

  4. bilirubin [ Time Frame: 28days ]
    bilirubin level



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624335


Locations
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Spain
Hospital Universitario de La Plana
Villarreal, Castellón, Spain, 12540
Sponsors and Collaborators
Pascual Gregori Roig
Hospital Universitario de la Plana
FUNDACIÓN DAVALOS FLETCHER
Investigators
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Study Chair: Vanesa Rodenas, PhD Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pascual Gregori Roig, Adjunct Pediatrician of University Hospital of La Plana (Spain), Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier: NCT03624335    
Other Study ID Numbers: CORD STUDY
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Protocol study & Data Analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pascual Gregori Roig, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana:
Umbilical cord clamping
Anemia Neonatal
Iron metabolism disorders
Additional relevant MeSH terms:
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Neoplasm Metastasis
Polycythemia
Anemia, Neonatal
Hyperbilirubinemia, Neonatal
Hyperbilirubinemia
Anemia
Hematologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Infant, Newborn, Diseases