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Delayed Cord Clamping in Infants Born by Cesarean Section

NCT03549884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-04-07

No results posted yet for this study

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.

Conditions

  • Umbilical Cord Management
  • Elective Cesarean Section

Interventions

PROCEDURE

Delayed cord clamping

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

PROCEDURE

Early cord clamping

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

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Principal Investigators

  • Daniele Trevisanuto, MD · University of Padova, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549884 on ClinicalTrials.gov