Acupuncture for Pain Relief During Perineal Repair After Childbirth

October 3, 2008 updated by: Sonderborg Hospital

Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

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

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Patient satisfaction with the given pain relief

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonderborg Hospital

Collaborators

Aase and Ejnar Danielsens Foundation
The Augustinus Foundation, Denmark.
The Danish Midwifery Organization

Investigators

  • Principal Investigator: Sara Kindberg, PhD Student, Aarhus University, Perinatal Epidemiological Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Estimate)

October 6, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11295 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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