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临床试验/NCT04351997
NCT04351997已完成不适用

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

Policlinico Abano Terme4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
4
主要终点
Placental transfusion

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
2 Days 至 2 Days(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.

结局指标

主要结局

Placental transfusion

时间窗: 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.

次要结局

  • Neonatal body weight decrease.(First and second day of life)
  • Blood gases(At birth)
  • Glucose(At birth)
  • Arterial cord blood gas analysis.(Second day of life.)
  • Lactate(At birth)

研究者

发起方
Policlinico Abano Terme
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincenzo Zanardo

Professor

Policlinico Abano Terme

研究点 (4)

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