Acupuncture for Pain Relief During Perineal Repair After Childbirth

This study has been completed.
Sponsor:
Collaborators:
The Danish Midwifery Organization
Aase and Ejnar Danielsens Foundation
The Augustinus Foundation, Denmark.
Information provided by:
Sonderborg Hospital
ClinicalTrials.gov Identifier:
NCT00328796
First received: May 19, 2006
Last updated: October 3, 2008
Last verified: September 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial

Resource links provided by NLM:


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:

  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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Obstetric Departments in the Hospitals of Southern Denmark
Sønderborg, Region South Denmark, Denmark
Sponsors and Collaborators
Sonderborg Hospital
The Danish Midwifery Organization
Aase and Ejnar Danielsens Foundation
The Augustinus Foundation, Denmark.
Investigators
Principal Investigator: Sara Kindberg, PhD Student Aarhus University, Perinatal Epidemiological Unit
  More Information

No publications provided

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

Keywords provided by Sonderborg Hospital:
Perineal
repair
episiotomies
midwives
pain relief
Episiotomy

Additional relevant MeSH terms:
Birth Injuries
Lacerations
Wounds and Injuries
Infant, Newborn, Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014