Umbilical Cord Clamping: What Are the Benefits

March 22, 2021 updated by: Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero

Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits

Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. Umbilical cord can be clamped within 30s or at least 1 min after birth. A lot of studies have shown that delayed umbilical cord clamping is associated with greater haemoglobin concentration, better iron storage between 3-6 months of life and lower incidence for transfusion and neonatal hypotension compared to immediate umbilical cord clumping. Newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Umbilical cord cutting determines the separation of the newborn from mother. Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. In the spontaneous labor there are two modalities to obtain umbilical cord clamping: the first modality is immediate umbilical cord clamping within 30s from birth. The second modality is delayed umbilical cord clamping at least 1 min after birth. After 1 min, cerebral blood flow is reduced again because of lower cardiac output.

A lot of studies have shown that delayed umbilical cord clamping is better than the early umbilical clamping because delayed umbilical cord clamping is associated with a great haemoglobin concentration in the newborns and best iron storage between 3-6 months of life and less incidence for transfusion and neonatal hypotension. Experimental studies, executed on animals and humans, analysed cardiocirculatory changes in the foetus immediately after birth and the importance of the delayed clamping for the hemodynamic stabilization, particularly in the lowest gestational age.

In a recent randomized study conducted in Nepal on 540 newborns, birth by eutocic delivery with 39.2 weeks of gestational age, showed that delayed umbilical cord clamping after 3 min of life is correlated with a better haemoglobin level and less incidence of anaemia at 8 months of life. Zhou et al. conducted a meta-analysis that included hematologic parameters obtained by umbilical cord, placenta and newborns blood.

Association of Italian Hospital Gynecologists Obstetricians (AOGOI) declared contraindicated conditions to execute a delayed umbilical cord clamping:

Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of fetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest. Monochorionic twins, Fetal Hydrops, Umbilical cord damaged, Isoimmunization Rh.

Researchers concluded that newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Haematocrit difference was greater between newborns birth by elective Caesarean Section compared to those birth by Caesarean Section in labor. Nowadays, researchers found no side effects of delayed umbilical cord clamping except a slight increase of phototherapy needs.

Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section. The aim of the study protocol is to investigate the effects of the clamping after 1 min from birth by elective Caesarean Section on heart rate, saturation, body temperature, bilirubin, haematocrit and glycemia.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25124
        • Department of mother and child's Health Poliambulanza Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Birth Body Weight = appropriate for gestational age
  • Delivery mode= Elective Caesarean Section
  • Mothers' BMI = 19-24,9
  • Mothers'age ≤ 37 years

Exclusion Criteria:

  • Admission in NICU;
  • Neonatal Resuscitation
  • Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of foetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest
  • Pathologies ;
  • Smoking mothers;
  • Assumption of drugs during pregnancy
  • Mother toxicomaniac

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control Group
Newborns will be subjected to umbilical cord immediate clamping
Procedure: Immediate umbilical cord clamping
Umbilical cord will be clamped immediately after the birth of the newborn
EXPERIMENTAL: Study Group
Newborns will be subjected to umbilical cord delayed clamping
Procedure: Delayed umbilical cord clamping
Umbilical cord will be clamped after 1 min after the birth of the newborn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Heart Rate After Delayed Umbilical Clamping
Time Frame: 5 minutes and 10 minutes after birth
It will be measured the change of heart rate (HR)
5 minutes and 10 minutes after birth
Change of Saturation After Delayed Umbilical Clamping
Time Frame: 5 minutes and 10 minutes after birth
Saturation change (SpO2)
5 minutes and 10 minutes after birth
Change of Temperature After Delayed Umbilical Clamping
Time Frame: 5 minutes after birth
Temperature change (T)
5 minutes after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping
Time Frame: 120 minutes after birth
hemo gluco test (HGT)
120 minutes after birth
Misuration of the Hematocrit After Delayed Umbilical Clamping
Time Frame: 72 hours of life
hematocrit (Ht)
72 hours of life
Misuration of the Bilirubin After Delayed Umbilical Clamping
Time Frame: 72 hours of life
bilirubin
72 hours of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Investigators

  • Principal Investigator: Giuseppe De Bernardo, M.D., Poliambulanza Foundation
  • Study Chair: Maurizio Giordano, B.Sc., University of Naples Federico II, School of Medicine
  • Study Director: Laura Linetti, Dr., Poliambulanza Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (ACTUAL)

March 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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