Placental Transfusion Clinical Trial
Official title:
Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
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.
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).
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