Clinical trial NCT04459442: Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping
Official title: Placental Transfusion in the 'Natural' Vaginal Delivery at Term: Effect of Early and Late Umbilical Cord Clamping
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematocrit Anemia
Acidosis
Keywords: Placental transfusion
Natural, two-step delivery
Early cord clamping
Delayed cord clamping
Lead sponsor: Policlinico Abano Terme
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomization), comparing early cord clamping (at 60 seconds) and delayed cord clamping (at 180 seconds) in 90 cases of 'normal', two-step vaginal births.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

Vaginal delivery

Exclusion Criteria:

Cesarean delivery

Primary outcomes:
measure: Placental transfusion.
timeFrame: Second day of life
measure: Cord blood pH
timeFrame: Second day of life.
Secondary outcomes:
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: