Acupuncture as Pain Relief and Relaxation During Childbirth

This study has been completed.
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
Fabrikant Mads Clausens Fond
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns og forskningscenter for alternativ behandling (VIFAB )
DADJ (Den almindelige Danske Jordemoderforening)
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00261755
First received: December 2, 2005
Last updated: May 6, 2008
Last verified: May 2008

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
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acupuncture Analgesia
  • Natural Childbirth
  • 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 Name: Acupuncture
  • 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 Name: TENS
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00261755
Akupunktur2001-41-1305
No
Lone Hvidman, MD,PhD, Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
University of Aarhus
  • 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
  • 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