NCT03878602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 19, 2021

Completed
Last Updated

April 19, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 14, 2019

Results QC Date

February 5, 2021

Last Update Submit

March 22, 2021

Conditions

Delayed Cord Clamping

Keywords

NewbornElective Caesaren SectionCord Clamping

Outcome Measures

Primary Outcomes (3)

  • Change of Heart Rate After Delayed Umbilical Clamping

    It will be measured the change of heart rate (HR)

    5 minutes and 10 minutes after birth

  • Change of Saturation After Delayed Umbilical Clamping

    Saturation change (SpO2)

    5 minutes and 10 minutes after birth

  • Change of Temperature After Delayed Umbilical Clamping

    Temperature change (T)

    5 minutes after birth

Secondary Outcomes (3)

  • Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping

    120 minutes after birth

  • Misuration of the Hematocrit After Delayed Umbilical Clamping

    72 hours of life

  • Misuration of the Bilirubin After Delayed Umbilical Clamping

    72 hours of life

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Newborns will be subjected to umbilical cord immediate clamping

Procedure: Immediate umbilical cord clamping

Study Group

EXPERIMENTAL

Newborns will be subjected to umbilical cord delayed clamping

Procedure: Delayed umbilical cord clamping

Interventions

Delayed umbilical cord clampingPROCEDURE

Umbilical cord will be clamped after 1 min after the birth of the newborn

Study Group
Immediate umbilical cord clampingPROCEDURE

Umbilical cord will be clamped immediately after the birth of the newborn

Control Group

Eligibility Criteria

Age37 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of mother and child's Health Poliambulanza Foundation

Brescia, 25124, Italy

Location

Related Publications (13)

  • Katheria A, Hosono S, El-Naggar W. A new wrinkle: Umbilical cord management (how, when, who). Semin Fetal Neonatal Med. 2018 Oct;23(5):321-326. doi: 10.1016/j.siny.2018.07.003. Epub 2018 Jul 20.

    PMID: 30076109RESULT

  • Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW, Kluckow M, te Pas AB, Morley CJ, Polglase GR, Hooper SB. Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs. J Physiol. 2013 Apr 15;591(8):2113-26. doi: 10.1113/jphysiol.2012.250084. Epub 2013 Feb 11.

    PMID: 23401615RESULT

  • Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping (physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm lambs. PLoS One. 2015 Feb 17;10(2):e0117504. doi: 10.1371/journal.pone.0117504. eCollection 2015.

    PMID: 25689406RESULT

  • Alzaree F, Elbohoty A, Abdellatif M. Early Versus Delayed Umbilical Cord Clamping on Physiologic Anemia of the Term Newborn Infant. Open Access Maced J Med Sci. 2018 Aug 15;6(8):1399-1404. doi: 10.3889/oamjms.2018.286. eCollection 2018 Aug 20.

    PMID: 30159064RESULT

  • Ghavam S, Batra D, Mercer J, Kugelman A, Hosono S, Oh W, Rabe H, Kirpalani H. Effects of placental transfusion in extremely low birthweight infants: meta-analysis of long- and short-term outcomes. Transfusion. 2014 Apr;54(4):1192-8. doi: 10.1111/trf.12469.

    PMID: 24843886RESULT

  • Backes CH, Rivera BK, Haque U, Bridge JA, Smith CV, Hutchon DJR, Mercer JS. Placental transfusion strategies in very preterm neonates: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jul;124(1):47-56. doi: 10.1097/AOG.0000000000000324.

    PMID: 24901269RESULT

  • Nevill E, Meyer MP. Effect of delayed cord clamping (DCC) on breathing and transition at birth in very preterm infants. Early Hum Dev. 2015 Jul;91(7):407-11. doi: 10.1016/j.earlhumdev.2015.04.013. Epub 2015 May 15.

    PMID: 25984654RESULT

  • 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

    RESULT

  • Valero J, Desantes D, Perales-Puchalt A, Rubio J, Diago Almela VJ, Perales A. Effect of delayed umbilical cord clamping on blood gas analysis. Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):21-3. doi: 10.1016/j.ejogrb.2012.01.020. Epub 2012 Mar 8.

    PMID: 22405491RESULT

  • Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.

    PMID: 28114607RESULT

  • Zhou YB, Li HT, Zhu LP, Liu JM. Impact of cesarean section on placental transfusion and iron-related hematological indices in term neonates: a systematic review and meta-analysis. Placenta. 2014 Jan;35(1):1-8. doi: 10.1016/j.placenta.2013.10.011. Epub 2013 Nov 20.

    PMID: 24290868RESULT

  • McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.

    PMID: 23843134RESULT

  • De Bernardo G, Giordano M, De Santis R, Castelli P, Sordino D, Trevisanuto D, Buonocore G, Perrone S. A randomized controlled study of immediate versus delayed umbilical cord clamping in infants born by elective caesarean section. Ital J Pediatr. 2020 May 24;46(1):71. doi: 10.1186/s13052-020-00835-2.

    PMID: 32448358DERIVED

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Dr.Giuseppe De Bernardo
Organization
Ospedale Buon Consiglio Fatebenefratelli
pinodebtin@gmail.com
3357441303

Study Officials

  • Giuseppe De Bernardo, M.D.

    Poliambulanza Foundation

    PRINCIPAL INVESTIGATOR

  • Maurizio Giordano, B.Sc.

    University of Naples Federico II, School of Medicine

    STUDY CHAIR

  • Laura Linetti, Dr.

    Poliambulanza Foundation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

October 15, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

April 19, 2021

Results First Posted

April 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)