Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04459442 |
| Other study ID # |
3278/AT/14 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Policlinico Abano Terme |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators conducted a randomized controlled trial (parallel group study with 1:1
randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping
(DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in
a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of
circulating compounds, without potentially detrimental acidosis.
Description:
Introduction: Placental transfusion supports an important blood transfer to the neonate,
promoting a more stable transition from fetal to extrauterine 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 (placental
transfusion). The most effective way to manage umbilical cord in in 'natural', 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 ECC vs. DCC) on the
placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and
capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary
outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.
Material and methods: This is a randomized clinical trial on the effect of different cord
management in newborns by 'natural', 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).
