Clinical trial NCT04351997: Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
Official title: Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placental Transfusion
Hematocrit Anemia
Keywords: Placental transfusion
Two-step delivery
Early cord clamping
Delayed cord clamping
Lead sponsor: Policlinico Abano Terme
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: Inclusion Criteria:

Vaginal delivery Gestational age \>37 weeks Natural process of labor

Exclusion Criteria:

Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.

Primary outcomes:
measure: Placental transfusion
timeFrame: Second day of life
Secondary outcomes:
measure: Arterial cord blood gas analysis.
timeFrame: Second day of life.
measure: Neonatal body weight decrease.
timeFrame: First and second day of life
measure: Blood gases
timeFrame: At birth
measure: Lactate
timeFrame: At birth
measure: Glucose
timeFrame: At birth
Other outcomes:
Locations:
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
state: Padua
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
city: Padua
country: Italy
facility: Padua University Hospital
Study officials:
References: