Randomised Study of the Effect of Acupuncture as Induction of Labour
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 主要终点
- In active delivery or not (over or equal to 3 cm)
研究概览
简要总结
The purpose of the study is to evaluate whether acupuncture can be used to ripen cervix before medicinal induction of labor or even be used as method for induction, and thereby eliminating other and more potentially harmful methods.
详细描述
Acupuncture has become a natural part of the range of treatments in obstetric departments in Denmark, but there is only little evidence to the effect of acupuncture.
Many of the induction procedures currently in use in Denmark also have a little risk of side effects. to mention a few: There is a increased risk of maternal and neonatal infection, bleeding, ruptured membranes and placental disruption as result of the use of endocervical balloon catheter. In connection with manual rupture of membranes there is an increased risk of umbilical prolapse, maternal and neonatal infection, affected fetal heart rate, scratches on the scalp and placental bleeding. By using misoprostol there has been seen hyperstimulation of uterus causing affected fetal heart rate.
Many women are asking for alternatives to the existing methods used in obstetric dept.s.
In order to assess the effect, or lack of, acupuncture might have, we want to use acupuncture in the study group on acupuncture points on hands, feet, ankles and back of the head. The control group will get placebo acupuncture needles on same locations. The included women will be treated with the kind of acupuncture that counts for the group to which shes been allocated on gestational age 41+6 at 8:00 am and 2:30 pm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age 41+6
- •Normal pregnancy, expecting a healthy baby
- •Verified due date
排除标准
- •Women who do not speak or understand Danish
- •Multiple pregnancy
- •In active labour
- •Previous sectio
- •Maternal diseases (i.e. Diabetes, preeclampsia, heart diseases)
- •Fetal diseases (i.e. foetus mors, IUGR, hydrocephalus)
- •Previous complicated delivery i.e. low Apgar score
- •Allergic to metal
- •Anticoagulatory treatment
结局指标
主要结局
In active delivery or not (over or equal to 3 cm)
时间窗: 24 hrs
次要结局
- Degree of dilatation of orificium(24 hrs)
- Ruptured membranes or not,(24 hrs)
- Increase in uterine activity or not,(24 hrs)
