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Sponsors and Collaborators: |
Skejby Hospital Skejby Research Fond Ringkjøbing County Research Fond Union of Midwives Research Fond |
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Information provided by: | Skejby Hospital |
ClinicalTrials.gov Identifier: | NCT00245752 |
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.
Condition | Intervention | Phase |
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Pregnancy Overdue - Week 41+6 |
Device: acupuncture |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Randomised Study of the Effect of Acupuncture as Induction of Labour |
Enrollment: | 125 |
Study Start Date: | November 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
in points bilaterally inBL 67, LI 4, SP6, one in GV20.
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Device: acupuncture
acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
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2: Sham Comparator
sham acupuncture
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Device: acupuncture
acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Skejby Hospital ( Jette Modlock ) |
Study ID Numbers: | 20040001 |
Study First Received: | October 26, 2005 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00245752 History of Changes |
Health Authority: | Denmark: Ethics Committee |
post term pregnancy acupuncture induction |
Pregnancy, Prolonged |