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Clinical Trials/NCT00261755
NCT00261755
Completed
Phase 1

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

University of Aarhus1 site in 1 country607 target enrollmentMarch 2001

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acupuncture Analgesia
Sponsor
University of Aarhus
Enrollment
607
Locations
1
Primary Endpoint
The need for conventional analgesic in each group.
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2001
End Date
May 2004
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The need for conventional analgesic in each group.

Time Frame: during labor

Secondary Outcomes

  • Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH(from randomization until birth)
  • 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)
  • Questionaries filled out by the parturients to investigate satisfactory with analgesic given.(two months after delivery)

Study Sites (1)

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