Acupuncture as Pain Relief and Relaxation During Childbirth

Natural Childbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261755
• Other study ID #: Akupunktur2001-41-1305
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 2, 2005
• Last updated: May 6, 2008
• Start date: March 2001
• Est. completion date: May 2004

Study information

• Verified date: May 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 607
• Est. completion date: May 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acupuncture Analgesia
• Natural Childbirth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Dept Obstetrics, Aarhus University Hospital, Skejby	Aarhus

Sponsors (11)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital Skejby, DADJ (Den almindelige Danske Jordemoderforening), Direktør E. Danielsen og Hustrus Fond, Else og Mogens Wedell-Wedellsborgs Fond, Fabrikant Mads Clausens Fond, Hede Nielsen, Kong Christian den Tiendes Fond, Lundbeck Foundation, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, Videns- og Forskningscenter for Alternativ Behandling

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The need for conventional analgesic in each group.		during labor	Yes
Secondary	Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH		from randomization until birth	Yes
Secondary	visual analogue scale is used to evaluate subjective effect on pain.		Just before randomization, one hour after randomization and subsequently every two hours until the child was born	Yes
Secondary	Questionaries filled out by the parturients to investigate satisfactory with analgesic given.		two months after delivery	Yes