Delayed Cord Clamping in Infants Born by Cesarean Section

Study Overview
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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.

Official Title
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Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial

Conditions
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Umbilical Cord Management, Elective Cesarean Section

Intervention / Treatment
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* Procedure: Delayed cord clamping
* Procedure: Early cord clamping


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed cord clamping (DCC)<br>Cord clamping will be performed after 60 seconds of life | Procedure: Delayed cord clamping<br>* Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section<br>|
| Active Comparator: Early cord clamping (ECC)<br>Cord clamping will be performed within 10 seconds of life | Procedure: Early cord clamping<br>* Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit |  | Day 2 of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preductal transcutaneous saturation (TcSaO2) |  | During the first 10 minutes of life | 
| Heart rate | (bpm) | During the first 10 minutes of life | 
| Arterial blood pressure | (mmHg) | At day 1, 2, 3 of life | 
| Total transcutaneous bilirubin | (mg/dl) | Day 3 of life | 
| Maternal blood losses | ml | At delivery | 
| Temperature at Normal nursery admission | Celsius degrees | At the time of normal nursery admission | 
| Time to the first breath | seconds | At birth | 
| Weight | g | Day 3 of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early cord Clamping, Delayed cord clamping, Full term infant, Elective cesarean section, Hematocrit, Postnatal adaptation