Influence of Acupuncture in the Placental Expulsion Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The Principal Outcome of the Study is the Placental Expulsion Time.
研究概览
简要总结
In this study, a single blind randomized trial is carried out in order to compare placental detachment times when Ren Mai 6 is stimulated and when a different placebo point is used. So, a lower detachment time is assumed to be related to a higher uterine contraction, and, therefore, a decrease in the hemorrhage postpartum. We focus on measuring the time it takes to placental delivery due to the fact that, if this point promotes the uterine contraction, then the placental delivery will be produced in a short time. Thus, this technique could decrease the hemorrhage postpartum.
The principal outcome of the study is the placental expulsion time. This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.
Concerning the secondary outcomes, the application of real acupuncture in Ren Mai 6 point, and sham acupuncture in the placebo point are considered. Their study is derived from the statistical analysis of the results of the principal outcome. The existence of pain related to the treatment and the degree of satisfaction of the mother is also a secondary outcome, analyzed by the survey that the midwife carries out no more than 2 hours after the labor. At last, it is important to highlight that the degree of satisfaction of the midwife is also considered as a secondary outcome, since it is registered in the same survey.
详细描述
This study is designed as a single-blind randomized clinical trial with parallel design, and third party evaluation at the Hospital Universitario Príncipe de Asturias in Alcalá de Henares (Madrid, Spain). The study will be carry out with primiparous women who were in labour at this hospital. Information sheets about the study will be distributed by the different health care centers coordinated by the hospital. The midwives will give the information sheets to pregnant women during the pregnancy's attendances. The aim is to let pregnant women know about the study before their labour date in order to encourage them to participate in it.
Pregnant women fulfilling all the inclusion criteria and none of the exclusion criteria will be invited to participate in the experiment. These requirements includes primiparous women from 20 to 35 years old, with 37 to 42 weeks of gestation, and with a low obstetric risk labor with epidural analgesia. It is important to highlight that the midwife responsible for the labor is different from the acupuncturist responsible for the treatment.
An envelope with 120 leaflets will be enabled, 60 with control group name and 60 with intervention group name. After the approval of the pregnant woman, the acupuncturist will ask a partner midwife, a doctor or a nursing assistant to randomly pick up one of the leaflets from the aforementioned envelope, so pregnant woman will be assigned to a group. It is important to highlight that both the midwife and the pregnant woman must not know about the assigned group.
In the labor ward, after the childbirth, the baby is placed on the abdomen of the puerperal mother to facilitate maternal link. Then, the umbilical cord is clamped by the midwife. After all this process, that takes around a minute, the needle will be placed by the acupuncturist in the position corresponding to the randomly assigned group.
In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm will be inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous women between 20 and 35 years old
- •Within 37 and 42 weeks of gestation
- •Low obstetric risk labor
- •With epidural analgesia
排除标准
- •Myomatosis
- •Coagulation disorders
- •Placental alterations (placenta previa or placenta accreta)
- •Uterine overdistension (multiple pregnancy, polyhydramnios or fetal macrosomia)
- •Previous abortions and subject to curettage evacuator.
- •Previous uterine surgeries
- •Prolonged labor (more than 11 hours) or too fast labor (less than 2 hours)
- •Use of uterine relaxants during childbirth (magnesium sulfate or halogenates anaesthetic drugs)
- •People uncapable to give the informed consent
结局指标
主要结局
The Principal Outcome of the Study is the Placental Expulsion Time.
时间窗: Up to 30 minutes after the newborn delivery
This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.
次要结局
- Percentage of Mothers That Would Recommend the Technique to Any of Her Friends(Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room)
- Degree of Ease With Which the Acupuncturist Administered the Treatment(Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room)
- Percentage of Participants Who Reported Experiencing Pain Related to Treatment(Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room)