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| Descriptive Information Fields | |||||
| Brief Title † | Can Acupuncture be Used as Preparation for Induction of Labour | ||||
| Official Title † | Randomised Study of the Effect of Acupuncture as Induction of Labour | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | In active delivery or not (over or equal to 3 cm) [ Time Frame: 24 hrs. ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Degree of dilatation of orificium [ Time Frame: 24 hrs ] [ Designated as safety issue: No ] Ruptured membranes or not, [ Time Frame: 24 hrs ] [ Designated as safety issue: No ] Increase in uterine activity or not, [ Time Frame: 24 hrs ] [ Designated as safety issue: No ] |
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| Condition † | Pregnancy Overdue - Week 41+6 | ||||
| Intervention † | Device: acupuncture | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 124 | ||||
| Start Date † | November 2005 | ||||
| Completion Date | September 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | Denmark | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00245752 | ||||
| Organization ID | 20040001 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Skejby Hospital | ||||
| Collaborators †† | Skejby Research Fond Ringkjøbing County Research Fond Union of Midwives Research Fond |
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| Investigators † |
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| Information Provided By | Skejby Hospital | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | October 26, 2005 | ||||
| Last Updated Date | July 1, 2008 | ||||