Delayed Cord Clamping in Infants Born by Cesarean Section

University Hospital Padova

Status: Completed

Conditions: Umbilical Cord Management; Elective Cesarean Section

Treatments: Procedure: Delayed cord clamping; Procedure: Early cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT03549884

4443/AO/18

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 1 to 3 days old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Delayed cord clamping (DCC)

Experimental group

Description:

Cord clamping will be performed after 60 seconds of life

Treatment:

Procedure: Delayed cord clamping

Early cord clamping (ECC)

Active Comparator group

Description:

Cord clamping will be performed within 10 seconds of life

Treatment:

Procedure: Early cord clamping