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Delayed Cord Clamping in Infants Born by Cesarean Section

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ClinicalTrials.gov Identifier: NCT03549884
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Daniele Trevisanuto, University Hospital Padova

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.


Condition or disease Intervention/treatment Phase
Umbilical Cord Management Elective Cesarean Section Procedure: Delayed cord clamping Procedure: Early cord clamping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Delayed cord clamping (DCC)
Cord clamping will be performed after 60 seconds of life
Procedure: Delayed cord clamping
Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section

Active Comparator: Early cord clamping (ECC)
Cord clamping will be performed within 10 seconds of life
Procedure: Early cord clamping
Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section




Primary Outcome Measures :
  1. Hematocrit [ Time Frame: Day 2 of life ]

Secondary Outcome Measures :
  1. Preductal transcutaneous saturation (TcSaO2) [ Time Frame: During the first 10 minutes of life ]
  2. Heart rate [ Time Frame: During the first 10 minutes of life ]
    (bpm)

  3. Arterial blood pressure [ Time Frame: At day 1, 2, 3 of life ]
    (mmHg)

  4. Total transcutaneous bilirubin [ Time Frame: Day 3 of life ]
    (mg/dl)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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): NCT03549884


Contacts
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Contact: Daniele Trevisanuto, MD 39 3406632734 daniele.trevisanuto@gmail.com
Contact: Beatrice Galeazzo, MD 049 8213545 beatrice.galeazzo@gmail.com

Locations
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Italy
Azienda Ospedaliera di Padova, University of Padova Recruiting
Padova, Italy, 35128
Contact: Daniele Trevisanuto, MD    39 0498213545      
Sponsors and Collaborators
University Hospital Padova
Investigators
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Principal Investigator: Daniele Trevisanuto, MD University of Padova, Italy

Publications:

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Responsible Party: Daniele Trevisanuto, Professor, University Hospital Padova
ClinicalTrials.gov Identifier: NCT03549884     History of Changes
Other Study ID Numbers: 4443/AO/18
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: July 2018
Access Criteria: Contacting PI by e-mail

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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 Daniele Trevisanuto, University Hospital Padova:
Early cord Clamping
Delayed cord clamping
Full term infant
Elective cesarean section
Hematocrit
Postnatal adaptation