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Acupuncture as Pain Relief and Relaxation During Childbirth

This study has been completed.
Information provided by University of Aarhus

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Descriptive Information Fields
Brief Title  Acupuncture as Pain Relief and Relaxation During Childbirth
Official Title  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.

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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  The need for conventional analgesic in each group. [ Time Frame: during labor ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH [ Time Frame: from randomization until birth ] [ Designated as safety issue: Yes ]
visual analogue scale is used to evaluate subjective effect on pain. [ Time Frame: Just before randomization, one hour after randomization and subsequently every two hours until the child was born ] [ Designated as safety issue: Yes ]
Questionaries filled out by the parturients to investigate satisfactory with analgesic given. [ Time Frame: two months after delivery ] [ Designated as safety issue: Yes ]
Condition  Acupuncture Analgesia
Natural Childbirth
Intervention  Procedure: Acupuncture
Other: TENS
Other: Traditional Group
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  607
Start Date  March 2001
Completion Date May 2004
Eligibility Criteria 

Inclusion Criteria:

  • Healthy, Danish speaking women with a normal singleton pregnancy giving birth at term 37 - 42 weeks) with a fetus in cephalic presentation.

Exclusion Criteria:

  • Women with medical diseases or complicated pregnancy. Women who has already received conventional analgesia during labor.
Gender Female
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Denmark
Administrative Information Fields
NCT ID  NCT00261755
Organization ID Akupunktur2001-41-1305
Secondary IDs ††
Study Sponsor  University of Aarhus
Collaborators †† Skejby Hospital
Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeckfonden
Fabrikant Mads Clausens Fond
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns og forskningscenter for alternativ behandling (VIFAB )
DADJ (Den almindelige Danske Jordemoderforening)
Investigators 
Study Chair:     Lone Hvidman, MD,PhD     Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark    
Study Chair:     Morten Hedegaard, MD, PhD     Department Obstetrics, Rigshospitalet, Denmark    
Principal Investigator:     Lissa Borup, Midwife     Department of Obstetrics, Aarhus University Hospital, Skejby    
Principal Investigator:     Winnie M. Wurlitzer, Midwife     Department of obstetrics, Aarhus University Hospital, Skejby    
Information Provided By University of Aarhus
Verification Date May 2008
First Received Date  December 2, 2005
Last Updated Date May 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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