Acupuncture for Pain Relief During Perineal Repair After Childbirth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00328796|
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : October 6, 2008
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 or disease||Intervention/treatment||Phase|
|Birth Injuries Lacerations Pain||Procedure: acupuncture in 6 specific points Drug: lidocaine 10mg/ml||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||February 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328796
|Obstetric Departments in the Hospitals of Southern Denmark|
|Sønderborg, Region South Denmark, Denmark|
|Principal Investigator:||Sara Kindberg, PhD Student||Aarhus University, Perinatal Epidemiological Unit|