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临床试验/NCT01894880
NCT01894880已完成不适用

Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年7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
35
试验地点
2
主要终点
Change of oxytocin level

研究概览

简要总结

In the past decades frequency of cesarean section was increasing. Bonding or early skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery bonding/early SSC is already well-established. After cesarean section this important process starts after termination of operation. A Cochran review analyzed randomized studies and shows positive effects of early SSC. Possible concerns to adopt bonding in the operating room are beside organizational ones (change of established processes) also a different ambiance in the operating room (temperature, light, noise). In a prospective randomized trial, early SSC after cesarean section should be analyzed.

Hypothesis

Mothers, who have the chance to bond immediately after birth in the operating room, have lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels. Adaptation of the newborn is within the normal range. Early bonding has a further positive effect on breast feeding, maternal pain processing and mental health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age > 18 years
  • signed written informed consent
  • single pregnancy
  • elective cesarean section (between 7am and 15pm)
  • Bleeding prophylaxis with Pabal® (carbetocin)

排除标准

  • Age < 18 years
  • disabled to give signed written informed consent
  • Disease of mother or unborn, which could influence the study or makes the study impossible (e.g. severe malformation)
  • Non elective cesarean
  • Desire to wean
  • Desire to leave the hospital within 6 hours after birth
  • Bleeding prophylaxis with Syntocinon® (oxytocin)

结局指标

主要结局

Change of oxytocin level

时间窗: before, 0 min and 25 minutes after birth

次要结局

  • Change of cortisol level(before, 0 min and 25 min after birth)
  • Change of alpha Amylase level(before, 0 min and 25 min after birth)
  • Change of chromogranin A level(before, 0 min and 25 min after birth)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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