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Anemia NeonatalNCT03624335

Influence of Umbilical Cord Clamping Time in the Newborn

A study testing ECC, DCC and Blood Test 6hours in people with Anemia Neonatal and Polycythemia Secondary, run by Pascual Gregori Roig at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 35 to 42 weeksHealthy volunteers can take part
What is being tested?
ECC, DCC and Blood Test 6hours
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
1 siteSpain
Study dates
23 Mar 2015to 31 Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 42 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de La Plana

    Villarreal, Castellón, 12540

Other trials in Spain

About this study

Official title: 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.

Read the 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).

Being tested
ECC, DCC, Blood Test 6hours, Blood Test 24hours, Blood Test 48hours
Keywords
Umbilical cord clamping, Anemia Neonatal, Iron metabolism disorders
Medical subject headings
Anemia, Neonatal, Hyperbilirubinemia, Neonatal, Iron Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECCProcedure or surgery

    Early clamping of the umbilical cord

  • DCCProcedure or surgery

    Delayed clamping of the umbilical cord

  • Blood Test 6hoursProcedure or surgery

    Blood Test 6hours

  • Blood Test 24hoursProcedure or surgery

    Blood Test 24hours

  • Blood Test 48hoursProcedure or surgery

    Blood Test 48hours

  • Blood Test 28daysProcedure or surgery

    Blood Test 28days

Study groups in NCT03624335
Study groupRoleWhat they receive
Group 1: ECCExperimentalIn 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
Receives: Procedure: ECC; Procedure: Blood Test 6hours; Procedure: Blood Test 24hours; Procedure: Blood Test 48hours; Procedure: Blood Test 28days
Group 2: DCCExperimentalIn 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
Receives: Procedure: DCC; Procedure: Blood Test 6hours; Procedure: Blood Test 24hours; Procedure: Blood Test 48hours; Procedure: Blood Test 28days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. haemoglobin

    haemoglobin level

    Measured: 6hours

  2. haemoglobin

    haemoglobin level

    Measured: 28 days

  3. haematocrit

    haematocrit level

    Measured: 6 hours

  4. haematocrit

    haematocrit level

    Measured: 28 days

Secondary outcomes (4)

  1. serum ferritin

    serum ferritin level

    Measured: 6hours

  2. serum ferritin

    serum ferritin level

    Measured: 28days

  3. bilirubin

    bilirubin level

    Measured: 6hours

  4. bilirubin

    bilirubin level

    Measured: 28days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start23 Mar 2015
  3. Primary completion31 Mar 2016
  4. Study completion31 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled trials comparing early and late cord clamping
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624335
Sponsor's protocol ID
CORD STUDY
Status last verified
Aug 2018
First submitted
2 Aug 2018
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Protocol study \& Data Analysis

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.

    PubMed 36126369

Questions about this trial

What is this clinical trial studying?

A study testing ECC, DCC and Blood Test 6hours in people with Anemia Neonatal and Polycythemia Secondary, run by Pascual Gregori Roig at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

haemoglobin (time frame: 6hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03624335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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