Hematocrit Anemia, Placental Transfusion
Conditions
Keywords
Placental transfusion, Two-step delivery, Early cord clamping, Delayed cord clamping
Brief summary
The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. In term infants born by' two-step' delivery, DCC results is a higher blood volume in the newborn and facilitates the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental neonatal outcomes.
Detailed description
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during natural 'two-step' delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values and placental transfusion. The most effective way to manage umbilical cord in in 'two-step' delivery 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 placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis. Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by 'two-step' delivery. After obtaining parental consent, all mothers \> 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).
Interventions
PROCEDURECord clamping
Umbilical cord clamping after delivery.
Sponsors
Policlinico Abano Terme
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The investigators conducted a randomized controlled trial (RCT) ,(parallel group study wit(h 1:1 randomisation) comparing early cord clamping( ECC) (at 60 seconds) and delayed cord clamping DCC) (at 180 seconds) in 90 cases of normal birth by' two-step' delivery.
Eligibility
Sex/Gender
ALL
Age
2 Days to 2 Days
Healthy volunteers
No
Inclusion criteria
Vaginal delivery Gestational age \>37 weeks Natural process of labor
Exclusion criteria
Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placental transfusion | Second day of life | We compared the effects of ECC and DCC on placental transfusion in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial cord blood gas analysis. | Second day of life. | Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis. |
| Neonatal body weight decrease. | First and second day of life | Neonatal body weight (Kg) and weight at discharge (Kg) |
| Blood gases | At birth | pH (units) |
| Lactate | At birth | mmol/L |
| Glucose | At birth | mg% |
Countries
Italy
Outcome results
None listed