Acupuncture as Pain Relief and Relaxation During Childbirth - Tabular View

Tracking Information

First Received Date ^ICMJE

December 2, 2005

Last Updated Date

May 6, 2008

Start Date ^ICMJE

March 2001

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

The need for conventionel analgesic in each group.
visual analog scale is used to evaluate subjective effect on pain.
Questionnarie filled out two months after delivery by the parturients to investigate satisfactory with analgesic given.

Change History

Complete list of historical versions of study NCT00261755 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

obstetric outcome: durration of labour, use of oxytocine, incidense of caesarean section, bleeding, apgar score, cord blood pH

Descriptive Information

Brief Title ^ICMJE

Acupuncture as Pain Relief and Relaxation During Childbirth

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Acupuncture Analgesia
Natural Childbirth

Intervention ^ICMJE

Procedure: Acupuncture
Other: TENS
Other: Traditional Group

Study Arms / Comparison Groups

Experimental: Acupuncture treatment during labor
Active Comparator: Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
Active Comparator: Traditional pain treatment during labor

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

607

Completion Date

May 2004

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00261755

Responsible Party

Lone Hvidman, MD,PhD, Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark

Study ID Numbers ^ICMJE

Akupunktur2001-41-1305

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Skejby Hospital
Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeck Foundation
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 ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP