Delayed Cord Clamping in Infants Born by Cesarean Section
- Conditions
- Umbilical Cord ManagementElective Cesarean Section
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 Heart rate During the first 10 minutes of life (bpm)
Temperature at Normal nursery admission At the time of normal nursery admission Celsius degrees
Time to the first breath At birth seconds
Maternal blood losses At delivery ml
Arterial blood pressure At day 1, 2, 3 of life (mmHg)
Weight Day 3 of life g
Total transcutaneous bilirubin Day 3 of life (mg/dl)
Trial Locations
- Locations (1)
Azienda Ospedaliera di Padova, University of Padova
🇮🇹Padova, Italy
Azienda Ospedaliera di Padova, University of Padova🇮🇹Padova, Italy