Acupuncture for Pain Relief During Perineal Repair After Childbirth - Full Text View

Sponsors and Collaborators:	Sonderborg Hospital The Danish Midwifery Organisation. Aase and Ejnar Danielsens Foundation The Augustinus Foundation, Denmark.
Information provided by:	Sonderborg Hospital
ClinicalTrials.gov Identifier:	NCT00328796

Purpose

Midwives and obstetricians are currently using acupuncture for several health problems during pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used as pain relief during the repair of lacerations in the female pelvic floor following childbirth.

Three acupuncture points in the ear have been reported highly effective for perineal pain relief. A scientific trial will compare acupuncture with traditional local anaesthetics when midwives conduct perineal repair just after delivery in the hospitals of Southern Denmark.

Condition	Intervention
Birth Injuries Lacerations Pain	Procedure: acupuncture in 6 specific points Drug: lidocaine 10mg/ml

MedlinePlus related topics: Acupuncture Anesthesia

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial

Further study details as provided by Sonderborg Hospital:

Primary Outcome Measures:

Need for additional pain relief during the perineal repair
Pain experienced during perineal repair reported 1 day after delivery
Wound healing evaluated 1 and 14 days after delivery

Secondary Outcome Measures:

Patient satisfaction with the given pain relief

Enrollment:	207
Study Start Date:	May 2006
Study Completion Date:	February 2008
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Detailed Description:

A randomised trial has been initiated. 226 healthy primipara are invited to participate if they deliver a child after gestation week 36 and sustain a perineal laceration or an episiotomy during childbirth.

The randomisation is done using a computer-controlled voice response system and the compared treatments are:

A: Acupuncture in Shen Men, GV20, BL36 and 2 needles in the upper ear.

B: Local anaesthetics (lidocaine 10 ml/mg) directly in the wound area.

Primary outcomes are:

Need for additional pain relief during the perineal repair.
Pain experienced during perineal repair reported 1 day after delivery.
Wound healing evaluated 1 and 14 days after delivery.
Patient satisfaction with the given pain relief.

Eligibility

Ages Eligible for Study:	15 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primipara
Healthy mother and child
Danish speaking
Perineal laceration or episiotomy that can be sutured by a midwife.

Exclusion Criteria:

Large perineal lacerations
Heavy bleeding after childbirth
No need for pain relief

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328796

Locations

Denmark, Region South Denmark
Obstetric Departments in the Hospitals of Southern Denmark
Sønderborg, Region South Denmark, Denmark

Sponsors and Collaborators

Sonderborg Hospital

The Danish Midwifery Organisation.

Aase and Ejnar Danielsens Foundation

The Augustinus Foundation, Denmark.

Investigators

Principal Investigator:

Sara Kindberg, PhD Student

Aarhus University, Perinatal Epidemiological Unit

More Information

Additional Information:

Home page for the clinical trial This link exits the ClinicalTrials.gov site

Home page for the Research Department in Southern Denmark This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	11295
Study First Received:	May 19, 2006
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00328796 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Sonderborg Hospital:

Perineal
repair
episiotomies

midwives
pain relief
Episiotomy

Study placed in the following topic categories:

Lacerations
Birth Injuries
Lidocaine
Wounds and Injuries
Anesthetics

Disorders of Environmental Origin
Infant, Newborn, Diseases
Pain
Anesthetics, Local

Additional relevant MeSH terms:

Lacerations
Birth Injuries
Wounds and Injuries
Disorders of Environmental Origin
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 07, 2009