Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
- Conditions
- Placental TransfusionHematocrit Anemia
- Interventions
- Procedure: Cord clamping
- Registration Number
- NCT04351997
- Lead Sponsor
- Policlinico Abano Terme
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Vaginal delivery Gestational age >37 weeks Natural process of labor
Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early cord clamping Cord clamping Cord clamping at 60 seconds after birth. Delayed cord clamping Cord clamping Cord clamping at 180 seconds after birth,
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Glucose At birth mg%
Arterial cord blood gas analysis. Second day of life. Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.
Lactate At birth mmol/L
Trial Locations
- Locations (2)
Padua University Hospital
🇮🇹Padua, Italy
Policlinico Abano Terme
🇮🇹Abano Terme, Italy