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