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Umbilical Cord Clamping: What Are the Benefits

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ClinicalTrials.gov Identifier: NCT03878602
Recruitment Status : Completed
First Posted : March 18, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE October 15, 2018
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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)
  • Change of saturation after delayed umbilical clamping [ Time Frame: 5 minutes and 10 minutes after birth ]
    Saturation change (SpO2)
  • Change of temperature after delayed umbilical clamping [ Time Frame: 5 minutes and 10 minutes after birth ]
    Temperature change (T)
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Objective of the study was evaluating the effect of delayed umbilical clamping on the change of heart rate [ Time Frame: 5 minutes and 10 minutes after birth ]
    It will be measured the change of heart rate (HR)
  • Objective of the study was evaluating the effect of delayed umbilical clamping on the change of saturation [ Time Frame: 5 minutes and 10 minutes after birth ]
    Saturation change (SpO2)
  • Objective of the study was evaluating the effect of delayed umbilical clamping on the change of temperature [ Time Frame: 5 minutes and 10 minutes after birth ]
    Temperature change (T)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Misuration of the hemo gluco test after delayed umbilical clamping [ Time Frame: 120 minutes after birth ]
    hemo gluco test (HGT)
  • Misuration of the hematocrit after delayed umbilical clamping [ Time Frame: 72 hours of life ]
    hematocrit (Ht)
  • Misuration of the bilirubin after delayed umbilical clamping [ Time Frame: 72 hours of life ]
    bilirubin
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Objective of the study was evaluating the effect of delayed umbilical clamping on hemo gluco test [ Time Frame: 120 minutes after birth ]
    hemo gluco test (HGT)
  • Objective of the study was evaluating the effect of delayed umbilical clamping on hematocrit [ Time Frame: 72 hours of life ]
    hematocrit (Ht)
  • Objective of the study was evaluating the effect of delayed umbilical clamping on bilirubin [ Time Frame: 72 hours of life ]
    bilirubin
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Clamping: What Are the Benefits
Official Title  ICMJE Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Delayed Cord Clamping
Intervention  ICMJE
  • Procedure: Delayed umbilical cord clamping
    Umbilical cord will be clamped after 1 min after the birth of the newborn
  • Procedure: Immediate umbilical cord clamping
    Umbilical cord will be clamped immediately after the birth of the newborn
Study Arms  ICMJE
  • Active Comparator: Control Group
    Newborns will be subjected to umbilical cord immediate clamping
    Intervention: Procedure: Immediate umbilical cord clamping
  • Experimental: Study Group
    Newborns will be subjected to umbilical cord delayed clamping
    Intervention: Procedure: Delayed umbilical cord clamping
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)
132
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
46
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 37 Weeks to 42 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878602
Other Study ID Numbers  ICMJE 3176
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero
Study Sponsor  ICMJE Fondazione Poliambulanza Istituto Ospedaliero
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Fondazione Poliambulanza Istituto Ospedaliero
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP