Can Acupuncture be Used as Preparation for Induction of Labour

Phase 2

Completed

• Conditions: Pregnancy Overdue - Week 41+6
• Interventions: Device: acupuncture

• Registration Number: NCT00245752
• Lead Sponsor: Aarhus University Hospital Skejby

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-28
• Study Start: 2005-11
• Primary Completion: 2008-07
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-04
• Last Update Posted: 2009-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	acupuncture	in points bilaterally inBL 67, LI 4, SP6, one in GV20.
2	acupuncture	sham acupuncture

Primary Outcome Measures

Name	Time	Method
In active delivery or not (over or equal to 3 cm)	24 hrs

Secondary Outcome Measures

Name	Time	Method
Degree of dilatation of orificium	24 hrs
Ruptured membranes or not,	24 hrs
Increase in uterine activity or not,	24 hrs