Delayed Cord Clamping in Infants Born by Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Umbilical Cord Management Elective Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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Delayed cord clamping (DCC)

Cord clamping will be performed after 60 seconds of life

Group Type EXPERIMENTAL

Delayed cord clamping

Intervention Type PROCEDURE

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

Early cord clamping (ECC)

Cord clamping will be performed within 10 seconds of life

Group Type ACTIVE_COMPARATOR

Early cord clamping

Intervention Type PROCEDURE

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

Interventions

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Delayed cord clamping

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

Intervention Type PROCEDURE

Early cord clamping

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes