- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261755
Acupuncture as Pain Relief and Relaxation During Childbirth
Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Aarhus, Denmark, 8200
- Dept Obstetrics, Aarhus University Hospital, Skejby
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture Group
Acupuncture treatment during labor
|
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.
|
Active Comparator: TENS Group
Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
|
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.
|
Active Comparator: Traditional Group
Traditional pain treatment during labor
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The need for conventional analgesic in each group.
Time Frame: during labor
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during labor
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH
Time Frame: from randomization until birth
|
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
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Just before randomization, one hour after randomization and subsequently every two hours until the child was born
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Questionaries filled out by the parturients to investigate satisfactory with analgesic given.
Time Frame: two months after delivery
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two months after delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Akupunktur2001-41-1305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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