Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

Conditions
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Placental Transfusion, Hematocrit Anemia

Intervention / Treatment
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* Procedure: Cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaginal delivery Gestational age >37 weeks Natural process of labor Exclusion Criteria: Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early cord clamping<br>Cord clamping at 60 seconds after birth. | Procedure: Cord clamping<br>* Umbilical cord clamping after delivery.<br>|
| Experimental: Delayed cord clamping<br>Cord clamping at 180 seconds after birth, | Procedure: Cord clamping<br>* Umbilical cord clamping after delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental transfusion | 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. | Second day of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial cord blood gas analysis. | Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis. | Second day of life. | 
| Neonatal body weight decrease. | Neonatal body weight (Kg) and weight at discharge (Kg) | First and second day of life | 
| Blood gases | pH (units) | At birth | 
| Lactate | mmol/L | At birth | 
| Glucose | mg% | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placental transfusion, Two-step delivery, Early cord clamping, Delayed cord clamping