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| Tracking Information | |||||
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| First Received Date ICMJE | October 26, 2005 | ||||
| Last Updated Date | February 4, 2009 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
In active delivery or not (over or equal to 3 cm) [ Time Frame: 24 hrs ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00245752 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Can Acupuncture be Used as Preparation for Induction of Labour | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Pregnancy Overdue - Week 41+6 | ||||
| Intervention ICMJE | Device: acupuncture | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 125 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00245752 | ||||
| Responsible Party | Jette Modlock, Skejby Hospital | ||||
| Study ID Numbers ICMJE | 20040001 | ||||
| Study Sponsor ICMJE | Skejby Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Skejby Hospital | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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