NCT03549884

Brief Summary

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean section, especially elective one, reduces the placental transfusion, mainly because of uterine atony. Therefore, during an elective cesarean section umbilical cord management may play a relevant role on blood passage to the neonate and, as consequence, it may affect neonatal hematological values and cardiovascular parameters. The most effective way to manage umbilical cord in in elective cesarean section remains to be established. Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the hematocrit on the second day of life; in addition, we will assess the effect on perinatal and postnatal cardiovascular parameters. Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by cesarean sections. After obtaining parental consent, all mothers \> 38 weeks' gestation will be assigned to eithr ECC or DCC group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome will be the hematocrit on day 2 of life. Secondary outcomes will be pre-ductal oxygen saturation (SaO2) and the heart rate (HR) during the first ten minutes after the birth, arterial blood pressures during the first 3 postnatal days and transcutaneous bilirubin (BT) at day 3 after birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 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

April 17, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

May 26, 2018

Last Update Submit

April 2, 2020

Conditions

Umbilical Cord ManagementElective Cesarean Section

Keywords

Early cord ClampingDelayed cord clampingFull term infantElective cesarean sectionHematocritPostnatal adaptation

Outcome Measures

Primary Outcomes (1)

  • Hematocrit

    Day 2 of life

Secondary Outcomes (8)

  • Preductal transcutaneous saturation (TcSaO2)

    During the first 10 minutes of life

  • Heart rate

    During the first 10 minutes of life

  • Arterial blood pressure

    At day 1, 2, 3 of life

  • Total transcutaneous bilirubin

    Day 3 of life

  • Maternal blood losses

    At delivery

  • +3 more secondary outcomes

Study Arms (2)

Delayed cord clamping (DCC)

EXPERIMENTAL

Cord clamping will be performed after 60 seconds of life

Procedure: Delayed cord clamping

Early cord clamping (ECC)

ACTIVE COMPARATOR

Cord clamping will be performed within 10 seconds of life

Procedure: Early cord clamping

Interventions

Delayed cord clampingPROCEDURE

Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section

Delayed cord clamping (DCC)
Early cord clampingPROCEDURE

Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section

Early cord clamping (ECC)

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Elective cesarean section
  • Gestational age \> or = 39 weeks
  • No labor
  • Single pregnancy
  • Parental consent; a written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian

You may not qualify if:

  • Emergent or urgent cesarean sections
  • Twin pregnancies
  • Parental refusal to participate to the study
  • Major congenital malformations (such as cardiopathies)
  • Chromosomic abnormalities
  • Fetal hydrops
  • Severe maternal diseases (such as hypertension)
  • Cord abnormalities (length \< 20 cm, funicular prolapse, funicular knots)
  • Intrauterine growth restriction (IUGR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Padova, University of Padova

Padua, 35128, Italy

Location

Related Publications (6)

  • Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.

    PMID: 26477415BACKGROUND

  • Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available.

    PMID: 26472855BACKGROUND

  • Katheria AC, Brown MK, Rich W, Arnell K. Providing a Placental Transfusion in Newborns Who Need Resuscitation. Front Pediatr. 2017 Jan 25;5:1. doi: 10.3389/fped.2017.00001. eCollection 2017.

    PMID: 28180126BACKGROUND

  • 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: 24290868BACKGROUND

  • Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.

    PMID: 22094494BACKGROUND

  • Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.

    PMID: 29097178BACKGROUND

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Daniele Trevisanuto, MD

    University of Padova, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The health care giver who will perform hematocrit measurement (primary outcome) and the statistician who will perform data analysis will be blind for treatment allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2018

First Posted

June 8, 2018

Study Start

April 17, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
July 2018
Access Criteria
Contacting PI by e-mail

Locations

IT(1)