Can Acupuncture be Used as Preparation for Induction of Labour

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomised Study of the Effect of Acupuncture as Induction of Labour

Conditions
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Pregnancy Overdue - Week 41+6

Intervention / Treatment
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* Device: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age 41+6 Normal pregnancy, expecting a healthy baby Verified due date Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>in points bilaterally inBL 67, LI 4, SP6, one in GV20. | Device: acupuncture<br>* acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.<br>* Other names: and Park Sham needles;|
| Sham Comparator: 2<br>sham acupuncture | Device: acupuncture<br>* acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.<br>* Other names: and Park Sham needles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In active delivery or not (over or equal to 3 cm) |  | 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of dilatation of orificium |  | 24 hrs | 
| Ruptured membranes or not, |  | 24 hrs | 
| Increase in uterine activity or not, |  | 24 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post term pregnancy, acupuncture, induction