Ignite Creation Date:
2024-05-06 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03549884
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2018-05-26
Brief Title:
Delayed Cord Clamping in Infants Born by Cesarean Section
Sponsor:
University Hospital Padova
Organization:
University Hospital Padova
Study Overview
Official Title:
Delayed Cord Clamping in Infants Born by Cesarean Section a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 11 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None