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临床试验/NCT05461950
NCT05461950已完成不适用

Feasibility-testing of Extra-uterine Placental Transfusion to Facilitate Intact-cord Stabilisation and Physiology-based Cord Clamping for Term and Preterm Infants Delivered by Acute or Planned Caesarean Section

Helse Møre og Romsdal HF1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
263
试验地点
1
主要终点
Intervention fidelity (cohort 2)

研究概览

简要总结

This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants.

详细描述

Standard procedure when an infant is delivered by caesarean section is to wait to clamp the umbilical cord for approximately one minute, and then transfer the infant to a designated area for assessment and stabilisation. If the infant needs immediate resuscitation, the umbilical cord is cut earlier to expedite transfer to resuscitation equipment and qualified care (including stimulation, clearing airways and respiratory support).

It has been suggested in several pilot and clinical studies that keeping the umbilical cord intact during the infant's transition from intra- to extrauterine life may improve outcomes and survival, especially for preterm infants. Since length of the umbilical cord is limited, finding ways to avoid cutting the cord while initiating stabilisation and care is warranted. To date, most studies have reported on interventions that involve mobile resuscitation equipment; thus keeping the infant in close proximity to the mother. This may be extra challenging in caesareans sections, especially due to space constraints and maintenance of sterility.

The objective of this study to determine whether extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for infants delivered by caesarean section is feasible, safe and acceptable for infants and their mothers, as well as for involved personnel.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
32 Weeks 至 42 Weeks(Child)
性别
Female
接受健康志愿者

入选标准

  • live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0
  • delivered by CS in regional anaesthesia
  • immediate care may be planned with involved personnel prior to delivery
  • informed maternal consent is obtained (parental consent on behalf of the unborn child).

排除标准

  • twins, triplets
  • significant congenital malformations
  • placenta complications with high risk of abnormal maternal blood loss
  • severe fetal distress requiring cesarean section in general anaesthesia (crash CS)
  • participation in any other clinical study within the last month
  • not sufficient time for preparations or collection of maternal/parental consent
  • mother does not comprehend Norwegian or English

结局指标

主要结局

Intervention fidelity (cohort 2)

时间窗: First 10 minutes after delivery

Extra-uterine placental transfusion + intact-cord stabilisation + physiology-based cord clamping applied (for infants needing any respiratory support), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.

Intervention fidelity (cohort 1)

时间窗: First 10 minutes after delivery

Extra-uterine placental transfusion + physiology-based cord clamping applied (for vigorous infants), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.

次要结局

  • Respiratory support (cohort 2)(First 10-15 minutes after birth)
  • Apgar score(At 5 minutes after birth (cohort 1+2))
  • Heart rate (cohort 1+2)(First 10 -15 minutes after birth)
  • Apgar score (cohort 1+2)(At 10 minutes after birth)
  • Residual placenta volume (cohort 1+2)(Within 10-15 minutes after birth)
  • Delivery of placenta (cohort 1+2)(At 1 minute (+/- 10 seconds) after birth)
  • Dry-electrode ECG attached (cohort 1+2)(Within 10 seconds after birth)
  • First cry or breathing effort (cohort 1+2)(Within 10 minutes after birth)
  • Umbilical cord blood samples (cohort 1+2)(Within 40-60 seconds after birth)
  • Duration of respiratory support (cohort 2)(First 10-15 minutes after birth)
  • Stabilisation (cohort 2)(Within 10-20 minutes after birth)
  • Cord clamping time (cohort 1+2)(Within 10 minutes after birth)
  • Skin-to-skin-contact (cohort 1+2)(Within 2 hours after birth)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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