Acupuncture as Pain Relief and Relaxation During Childbirth

Phase 1

Completed

• Conditions: Acupuncture Analgesia; Natural Childbirth
• Interventions: Procedure: Acupuncture; Other: TENS; Other: Traditional Group

• Registration Number: NCT00261755
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2004-02
• Study Completion: 2004-05
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-05
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 607

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Group	Acupuncture	Acupuncture treatment during labor
TENS Group	TENS	Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
Traditional Group	Traditional Group	Traditional pain treatment during labor

Primary Outcome Measures

Name	Time	Method
The need for conventional analgesic in each group.	during labor

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept Obstetrics, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark