Randomised ,Single Blind, Placebo Controlled in Meir Medical Center. Study the Potential of Acupuncture Therapy to Reduce the Need for Labor Induction After Postdate (Week 41)
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The number of women who received birth induction after week 41
研究概览
简要总结
In recent years, it is accepted to induce birth at week 41 in order to reduce the risk in surplus pregnancies. It was found that after 41 weeks, there is a significant increase in pregnancy complications including meconium liquor, shoulder dystocia and fetal death in uterus.
Induction at 41 weeks was found to reduce the risk of complications described above, without taking the risk of cesarean section and, therefore, the recommendation of the Israel Society of Maternal Fetal Medicine, is to induce birth for women who completed 41 weeks of pregnancy.
Induction is performed mechanically by entering a balloon to the cervix or by medicated prostaglandins and later, intravenous Pitocin to most women. The process takes two to three days with about 60-70% success rate.
In recent years there has been a growing awareness to use natural methods to start labor.
Many women tend to turn to natural medicine in order to reduce the need for conventional drugs to start labor.
Given the lack of research on the issue and considering the rising demand of the involvement of alternative medicine in labor induction process, the investigators decided to carry out research on this subject.
详细描述
To the study will be recruited women who have completed 40 weeks of pregnancy and have not yet given birth, with proper evaluation of mother and fetus.
Women who are fit to participate and had given their consent, will be computerized randomized to one of three groups.
Research groups:
- Group who receives acupuncture treatment in order to accelerate the development of birth.
- Group who receives sham treatment - non acupuncture treatment, but a similar treatment, so that the patient is unable to know whether she is receiving a real acupuncture treatment, or the similar one, which has no effect on the patient.
- Group who does not receive any treatment and will be reviewed a week later, unless a spontaneous birth will be developed. (Procedure accepted today) The study will be carried out between week 40 and week 41. During the week acupuncture treatment, sham treatment or conservative follow-up will be carried out, depending on the study group differentiation.
All women who will be randomized to the treatment groups, will fill a preliminary questionnaire for acupuncture treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women past their due date (week 40)
- •Proper dating of pregnancy
- •Uncomplicated pregnancy
- •Normal evaluation as part of the mother and fetus routine examination on week 40
- •Singleton pregnancy
- •No contraindication for vaginal birth
- •No significant signs of birth
排除标准
- •Past Cesarean Section
- •Women who have undergone acupuncture treatment during pregnancy
- •Women who did not undergo separation membranes
结局指标
主要结局
The number of women who received birth induction after week 41
时间窗: three weeks
次要结局
- Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).(three weeks)
- Duration of labour(three weeks)
- Number of women who received epidural(three weeks)
- Apgar score after birth(three weeks)
- Type of labour(three weeks)
- Time past from treatment (acupuncture vs. placebo) till labour(three weeks)
- Hg before and after labour(three weeks)