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Acupuncture as Pain Relief and Relaxation During Childbirth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00261755
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : May 7, 2008
Sponsor:
Collaborators:
Aarhus University Hospital Skejby
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeck Foundation
Manufacturer Mads Clausen Foundation
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns- og Forskningscenter for Alternativ Behandling
DADJ (Den almindelige Danske Jordemoderforening)
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE December 2, 2005
First Posted Date  ICMJE December 5, 2005
Last Update Posted Date May 7, 2008
Study Start Date  ICMJE March 2001
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
The need for conventional analgesic in each group. [ Time Frame: during labor ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2005)
  • The need for conventionel analgesic in each group.
  • visual analogue 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
  • Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH [ Time Frame: from randomization until birth ]
  • 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 ]
  • Questionaries filled out by the parturients to investigate satisfactory with analgesic given. [ Time Frame: two months after delivery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2005)
obstetric outcome: durration of labour, use of oxytocine, incidense of caesarean section, bleeding, apgar score, cord blood pH
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acupuncture Analgesia
  • Natural Childbirth
Intervention  ICMJE
  • Procedure: Acupuncture
    Based on international experiences and experiences from the pilot project 34 specified acupuncture points could be used.Treatment was individualised according to the woman's mobility and localization of pain. Needles were sterile stainless steel acupuncture needles in three lengths: 0.20 x 15 mm, 0.30 x 30 mm and 0.35 x 50 mm. No electric stimulation was used. The duration of needling could vary from 30 minutes to two hours and could be repeated. The needles were removed if the patient felt uncomfortable or in cases with obstetric pathology.
  • Other: TENS
    The Transcutaneous Electric Nerve Stimulation (TENS treatment) was carried out using a B.C - TENS 120Z unit. Two to four electrodes were placed on the skin of the lower back. The units were set in constant mode, initially with a pulse width of 60 micro-seconds and a pulse rate of 100 pulses per second. The treatment lasted from 20 to 45 minutes and could be repeated. The intensity of stimulation could be adjusted by the woman or the midwife.
  • Other: Traditional Group
    All analgesic methods available (Sterile water papules, nitro oxygen, bath tub, pethidine and epidural analgesics (EDA)). A specific analgesic was chosen by the woman and the midwife after informed choice.
    Other Name: Tratitional analgesic
Study Arms  ICMJE
  • Experimental: Acupuncture Group
    Acupuncture treatment during labor
    Intervention: Procedure: Acupuncture
  • Active Comparator: TENS Group
    Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
    Intervention: Other: TENS
  • Active Comparator: Traditional Group
    Traditional pain treatment during labor
    Intervention: Other: Traditional Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2005)
607
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00261755
Other Study ID Numbers  ICMJE Akupunktur2001-41-1305
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lone Hvidman, MD,PhD, Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Aarhus University Hospital Skejby
  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
  • Direktør E. Danielsen og Hustrus Fond
  • Kong Christian den Tiendes Fond
  • Lundbeck Foundation
  • Manufacturer Mads Clausen Foundation
  • Else og Mogens Wedell-Wedellsborgs Fond
  • Hede Nielsen
  • Videns- og Forskningscenter for Alternativ Behandling
  • DADJ (Den almindelige Danske Jordemoderforening)
Investigators  ICMJE
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
PRS Account University of Aarhus
Verification Date May 2008

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