Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Pain in relation to breastfeeding
研究概览
简要总结
Oxytocin is a hormone that is released in response to distension of the cervix and uterus during labor, and after breast feeding as a result of nipple stimulation. In addition to oxytocin facilitating birth and breastfeeding, oxytocin has a number of effects on maternal behavior including bonding, social recognition, anxiolysis, sexual arousal.
The role of oxytocin in pain modulation has recently been highlighted. Intranasal or intrathecal (spinal) administration has been found to impact pain modulation. The administration of intravenous oxytocin has not provided effective analgesia because oxytocin is unable to pass to your brain. The role of breastfeeding on analgesia is poorly investigated, which is why we are carrying out this study.
详细描述
Patients will be recruited by a member of the research team when the patient is admitted to labor or delivery and when they are in the post-natal floor.
Patients will be divided into two groups initially depending on mode of delivery, vaginal vs. cesarean. The vaginal delivery group will be randomized into three groups. One group will be told that we are investigating the effect of oxytocin on pain intensity, the second group will be told that it reduces pain intensity, the third group will be told that it increases pain intensity.
The cesarean group are not going to be randomized, they will be told we are investigating the effect of oxytocin on pain intensity.
Demographic and obstetric will be collected by patient questioning as well as from the medical record on Day 1 post delivery. Analgesia data from the medical record will also be collected on days 1 and 2 post-delivery.
The primary outcome measure will be change in pain scores (0=no pain, 10=worse pain imaginable) during and after breastfeeding compared to pain before. We will examine both vaginal, cramping and surgical pain as appropriate.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 40 yrs
- •Singleton gestation
- •Greater or equal to 37 weeks gestation
- •Vaginal delivery
- •Scheduled cesarean delivery with a Pfannenstiel incision
排除标准
- •Chronic pain
- •Patients prescribed regular analgesia medication ante-natally
- •Substance abuse
- •Classical cesarean incision
- •Emergency cesarean delivery
- •Patients not planning to breastfeed
- •Psychiatric or cognitive disorder, including anxiety or depression
- •Physicians, labor and delivery nurses, midwives
结局指标
主要结局
Pain in relation to breastfeeding
时间窗: 6 weeks post-delivery
The primary outcome measure will be change in pain scores (0=no pain, 10=worse pain imaginable) during and after breastfeeding compared to pain before. We will examine both vaginal, cramping and surgical pain as appropriate. The patients will be given a breastfeeding diary to complete, which will record the average pain scores (0-10) before, during and after each breastfeed.
次要结局
- To determine the effects of suggestion and mood on pain(6wks)
- To understand patients' preference for duration versus intensity of pain(48 h)
研究者
Brendan Carvalho
Associate Professor
Stanford University