Can Acupuncture be Used as Preparation for Induction of Labour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-12-31

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.

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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.

Conditions

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Pregnancy Overdue - Week 41+6

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

in points bilaterally inBL 67, LI 4, SP6, one in GV20.

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type DEVICE

acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.

2

sham acupuncture

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type DEVICE

acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.

Interventions

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acupuncture

acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.

Intervention Type DEVICE

Other Intervention Names

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Seirin Steel needles and Park Sham needles

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes