Delayed Cord Clamping in Infants Born by Cesarean Section

Not Applicable

Completed

• Conditions: Umbilical Cord Management; Elective Cesarean Section
• Interventions: Procedure: Delayed cord clamping; Procedure: Early cord clamping

• Registration Number: NCT03549884
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Study First Submitted: 2018-05-26
• Study First Submitted QC: 2018-05-26
• Study First Posted: 2018-06-08
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed cord clamping (DCC)	Delayed cord clamping	Cord clamping will be performed after 60 seconds of life
Early cord clamping (ECC)	Early cord clamping	Cord clamping will be performed within 10 seconds of life

Primary Outcome Measures

Name	Time	Method
Hematocrit	Day 2 of life

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova, University of Padova; 🇮🇹 Padova, Italy