Acupuncture as Pain Relief and Relaxation During Childbirth
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| First Received Date ICMJE | December 2, 2005 | ||||||||||||||||
| Last Updated Date | May 6, 2008 | ||||||||||||||||
| Start Date ICMJE | March 2001 | ||||||||||||||||
| Primary Completion Date | February 2004 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
The need for conventional analgesic in each group. [ Time Frame: during labor ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00261755 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
obstetric outcome: durration of labour, use of oxytocine, incidense of caesarean section, bleeding, apgar score, cord blood pH | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Acupuncture as Pain Relief and Relaxation During Childbirth | ||||||||||||||||
| Official Title ICMJE | Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study | ||||||||||||||||
| Brief Summary | The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth. |
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| Detailed Description | The purpose of this study is to investigate the effect of acupuncture for pain relief an relaxation during childbirth. In a controlled study 607 healthy patients in active labor at term are randomly assigned to receive either acupuncture, TENS or traditional analgesia. Pharmacological analgesia is provided on request. The treatment is administered by midwives trained in acupuncture and TENS. The objective parameter of outcome is the need for conventional analgesia in each group. Visual analogue scale assessments are used to evaluate participants perception of pain before, during and after treatment. Questionnaires filled out two months after delivery is used to investigate the patients experience and satisfaction with delivery and analgesia. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 607 | ||||||||||||||||
| Completion Date | May 2004 | ||||||||||||||||
| Primary Completion Date | February 2004 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||||||
| Ages | Not Provided | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Denmark | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00261755 | ||||||||||||||||
| Other Study ID Numbers ICMJE | Akupunktur2001-41-1305 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Lone Hvidman, MD,PhD, Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark | ||||||||||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||||||||||
| Verification Date | May 2008 | ||||||||||||||||
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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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