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Acupuncture as Pain Relief and Relaxation During Childbirth
This study has been completed.
Study NCT00261755   Information provided by University of Aarhus
First Received: December 2, 2005   Last Updated: May 6, 2008   History of Changes

December 2, 2005
May 6, 2008
March 2001
February 2004   (final data collection date for primary outcome measure)
The need for conventional analgesic in each group. [ Time Frame: during labor ] [ Designated as safety issue: Yes ]
  • The need for conventionel analgesic in each group.
  • visual analog scale is used to evaluate subjective effect on pain.
  • Questionnarie filled out two months after delivery by the parturients to investigate satisfactory with analgesic given.
Complete list of historical versions of study NCT00261755 on ClinicalTrials.gov Archive Site
  • 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 ]
obstetric outcome: durration of labour, use of oxytocine, incidense of caesarean section, bleeding, apgar score, cord blood pH
 
Acupuncture as Pain Relief and Relaxation During Childbirth
Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study

The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Acupuncture Analgesia
  • Natural Childbirth
  • Procedure: Acupuncture
  • Other: TENS
  • Other: Traditional Group
  • Experimental: Acupuncture treatment during labor
  • Active Comparator: Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
  • Active Comparator: Traditional pain treatment during labor
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
607
May 2004
February 2004   (final data collection date for primary outcome measure)

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.
Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00261755
Lone Hvidman, MD,PhD, Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
Akupunktur2001-41-1305
University of Aarhus
  • Skejby Hospital
  • Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
  • Direktør E. Danielsen og Hustrus Fond
  • Kong Christian den Tiendes Fond
  • Lundbeck Foundation
  • Fabrikant Mads Clausens Fond
  • Else og Mogens Wedell-Wedellsborgs Fond
  • Hede Nielsen
  • Videns og forskningscenter for alternativ behandling (VIFAB )
  • DADJ (Den almindelige Danske Jordemoderforening)
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
University of Aarhus
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP