Acupuncture for Pain Relief During Perineal Repair After Childbirth
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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 |
- 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
| 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) |
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 |
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| Denmark | |
| Obstetric Departments in the Hospitals of Southern Denmark | |
| Sønderborg, Region South Denmark, Denmark | |
| 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 Infant, Newborn, Diseases Wounds and Injuries 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 May 16, 2013