Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Rate of intact perineum after childbirth
研究概览
简要总结
During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present.
After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. The patient's participation in the study ends when she leaves the labour room after the birth.
详细描述
During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present. She's responsible for explaining the purpose and practicalities of the study orally and issues a written information document. The information provided is the same regardless of the midwife present. If she agrees to participate in the study, the patient signs the consent form.
After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. She collects the clinical Research Form from the time the patient signs the consent form until she leaves the labour room after the birth.
The patient's participation in the study ends when she leaves the labour room after the birth. No further follow-up is planned.
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)
盲法说明
Participant doesn't know if the point punctured is the experimental or the placebo point.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primiparous or multiparous women who have never given birth vaginally
- •term patients (after 37 weeks of amenorrhea)
- •patients delivering a fetus in cephalic presentation
- •patients speaking and understanding French.
排除标准
- •patients suspected of having a fetal macrosomy (greater than the 97th percentile) on the last ultrasound
- •patients with twin pregnancies
- •excised patients
- •patient who has made an acupuncture preparation during pregnancy
- •patients with fetal death in utero
- •patients requiring medical termination of pregnancy
研究组 & 干预措施
puncture of the RP6 point
The acupuncturist midwife, who does not perform the delivery herself, punctures the RP6 point at the time of the expulsive efforts.
干预措施: Puncture of the RP6 point (Other)
puncture of the placebo point
The acupuncturist midwife, who does not perform the delivery herself, punctures the placebo point at the time of the expulsive efforts.
干预措施: Puncture of the placebo point (Other)
结局指标
主要结局
Rate of intact perineum after childbirth
时间窗: immediately after childbirth
Rate of intact perineum after childbirth
次要结局
- Rate of episiotomies performed(immediately after childbirth)
- Rate of complete perineal tears(immediately after childbirth)
- Rate of complicated complete perineal tears(immediately after childbirth)
- Rate of simple perineal tears(immediately after childbirth)