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Completed

NCT Number: NCT00328796

Acupuncture for Pain Relief During Perineal Repair After Childbirth

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.

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Key information

Conditions

Birth Injuries Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Lacerations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

15 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetric Departments in the Hospitals of Southern Denmark

Sønderborg, Region Syddanmark, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture in 6 specific points

Procedure

lidocaine 10mg/ml

Drug

Primary outcomes

  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

Secondary outcomes

  1. Patient satisfaction with the given pain relief

Sponsors and collaborators

Lead sponsor

Sonderborg Hospital

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
May 22, 2006
Registry last updated
Oct 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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