Acupuncture as Pain Relief and Relaxation During Childbirth - Tabular View

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Acupuncture as Pain Relief and Relaxation During Childbirth

This study has been completed.
Information provided by University of Aarhus

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Acupuncture as Pain Relief and Relaxation During Childbirth

Official Title ^†

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

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 Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

The need for conventional analgesic in each group. [ Time Frame: during labor ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH [ Time Frame: from randomization until birth ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Questionaries filled out by the parturients to investigate satisfactory with analgesic given. [ Time Frame: two months after delivery ] [ Designated as safety issue: Yes ]

Condition ^†

Acupuncture Analgesia
Natural Childbirth

Intervention ^†

Procedure: Acupuncture
Other: TENS
Other: Traditional Group

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

607

Start Date ^†

March 2001

Completion Date

May 2004

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.

Gender

Female

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Denmark

Administrative Information Fields

NCT ID ^†

NCT00261755

Organization ID

Akupunktur2001-41-1305

Secondary IDs ^††

Study Sponsor ^†

University of Aarhus

Collaborators ^††

Skejby Hospital
Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeckfonden
Fabrikant Mads Clausens Fond
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns og forskningscenter for alternativ behandling (VIFAB )
DADJ (Den almindelige Danske Jordemoderforening)

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

Information Provided By

University of Aarhus

Verification Date

May 2008

First Received Date ^†

December 2, 2005

Last Updated Date

May 6, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.