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Completed

NCT Number: NCT00261755

Acupuncture as Pain Relief and Relaxation During Childbirth

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

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Key information

Conditions

Acupuncture Analgesia Natural Childbirth

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dept Obstetrics, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

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.

TENS

Other

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.

Traditional Group

Other

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 names: Tratitional analgesic

Primary outcomes

  1. The need for conventional analgesic in each group.

    Time frame: during labor

Secondary outcomes

  1. Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH

    Time frame: from randomization until birth

  2. 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

  3. Questionaries filled out by the parturients to investigate satisfactory with analgesic given.

    Time frame: two months after delivery

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital Skejby
  • DADJ (Den almindelige Danske Jordemoderforening)
  • Direktør E. Danielsen og Hustrus Fond
  • Else og Mogens Wedell-Wedellsborgs Fond
  • Kong Christian den Tiendes Fond
  • Lundbeck Foundation
  • Manufacturer Mads Clausen Foundation
  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
  • The Hede Nielsen Family Foundation
  • Videns- og Forskningscenter for Alternativ Behandling

Registry information

Official study title

Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Dec 5, 2005
Registry last updated
May 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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