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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

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.

Condition or disease Intervention/treatment Phase
Delayed Cord Clamping Procedure: Delayed umbilical cord clamping Procedure: Immediate umbilical cord clamping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

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




Primary Outcome Measures :
  1. 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)

  2. Change of saturation after delayed umbilical clamping [ Time Frame: 5 minutes and 10 minutes after birth ]
    Saturation change (SpO2)

  3. Change of temperature after delayed umbilical clamping [ Time Frame: 5 minutes and 10 minutes after birth ]
    Temperature change (T)


Secondary Outcome Measures :
  1. Misuration of the hemo gluco test after delayed umbilical clamping [ Time Frame: 120 minutes after birth ]
    hemo gluco test (HGT)

  2. Misuration of the hematocrit after delayed umbilical clamping [ Time Frame: 72 hours of life ]
    hematocrit (Ht)

  3. Misuration of the bilirubin after delayed umbilical clamping [ Time Frame: 72 hours of life ]
    bilirubin



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Ages Eligible for Study:   37 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03878602


Locations
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Italy
Department of mother and child's Health Poliambulanza Foundation
Brescia, Italy, 25124
Sponsors and Collaborators
Fondazione Poliambulanza Istituto Ospedaliero
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero:
Publications of Results:

Other Publications:
Wafaa Taha Ibrahim Elgzar, Heba Abdel-Fatah Ibrahim, Hanan Heiba Elkhateeb."Effects of Deferred Versus Early Umbilical Cord Clamping on Maternal and Neonatal Outcomes" - American Journal of Nursing Research, 2017,5(4), 115-128

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giuseppe De Bernando, Principal Investigator, Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier: NCT03878602    
Other Study ID Numbers: 3176
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero:
Newborn
Elective Caesaren Section
Cord Clamping