Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping

Study Overview
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Brief Summary
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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
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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).

Official Title
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Placental Transfusion in the 'Natural' Vaginal Delivery at Term: Effect of Early and Late Umbilical Cord Clamping

Conditions
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Hematocrit Anemia, Acidosis

Intervention / Treatment
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* Procedure: Umbilical cord clamping at birth.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaginal delivery Exclusion Criteria: Cesarean delivery

Ages Eligible for Study
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Minimum Age: 1 Minute
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: 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.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental transfusion. | Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age. | Second day of life | 
| Cord blood pH | pH estimate in arterial cord blood gas analysis | Second day of life. | 

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