Azienda Ospedaliera di Padova, University of Padova
Padova, 35128, Italy
NCT Number: NCT03549884
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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All sexes
Interventional
Not applicable
Padova, 35128, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section
Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section
Time frame: Day 2 of life
Time frame: During the first 10 minutes of life
Time frame: During the first 10 minutes of life
(bpm)
Time frame: At day 1, 2, 3 of life
(mmHg)
Time frame: Day 3 of life
(mg/dl)
Time frame: At delivery
ml
Time frame: At the time of normal nursery admission
Celsius degrees
Time frame: At birth
seconds
Time frame: Day 3 of life
g
University Hospital Padova
Other
Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial
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