Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital Padova
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Hematocrit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
The health care giver who will perform hematocrit measurement (primary outcome) and the statistician who will perform data analysis will be blind for treatment allocation.
Eligibility Criteria
- Ages
- 1 Day to 3 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Elective cesarean section
- •Gestational age > or = 39 weeks
- •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)
Outcomes
Primary Outcomes
Hematocrit
Time Frame: Day 2 of life
Secondary Outcomes
- Arterial blood pressure(At day 1, 2, 3 of life)
- Total transcutaneous bilirubin(Day 3 of life)
- Preductal transcutaneous saturation (TcSaO2)(During the first 10 minutes of life)
- Maternal blood losses(At delivery)
- Heart rate(During the first 10 minutes of life)
- Temperature at Normal nursery admission(At the time of normal nursery admission)
- Time to the first breath(At birth)
- Weight(Day 3 of life)
Investigators
Daniele Trevisanuto
Professor
University Hospital Padova