Acupuncture for Pain Relief During Perineal Repair After Childbirth
Primary Purpose
Birth Injuries, Lacerations, Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
acupuncture in 6 specific points
lidocaine 10mg/ml
Sponsored by
About this trial
This is an interventional treatment trial for Birth Injuries focused on measuring Perineal, repair, episiotomies, midwives, pain relief, Episiotomy
Eligibility 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
Sites / Locations
- Obstetric Departments in the Hospitals of Southern Denmark
Outcomes
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
Full Information
NCT ID
NCT00328796
First Posted
May 19, 2006
Last Updated
October 3, 2008
Sponsor
Sonderborg Hospital
Collaborators
The Danish Midwifery Organization, Aase and Ejnar Danielsens Foundation, The Augustinus Foundation, Denmark.
1. Study Identification
Unique Protocol Identification Number
NCT00328796
Brief Title
Acupuncture for Pain Relief During Perineal Repair After Childbirth
Official Title
Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sonderborg Hospital
Collaborators
The Danish Midwifery Organization, Aase and Ejnar Danielsens Foundation, The Augustinus Foundation, Denmark.
4. Oversight
5. Study Description
Brief Summary
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Injuries, Lacerations, Pain
Keywords
Perineal, repair, episiotomies, midwives, pain relief, Episiotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
acupuncture in 6 specific points
Intervention Type
Drug
Intervention Name(s)
lidocaine 10mg/ml
Primary Outcome Measure Information:
Title
Need for additional pain relief during the perineal repair
Title
Pain experienced during perineal repair reported 1 day after delivery
Title
Wound healing evaluated 1 and 14 days after delivery
Secondary Outcome Measure Information:
Title
Patient satisfaction with the given pain relief
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Kindberg, PhD Student
Organizational Affiliation
Aarhus University, Perinatal Epidemiological Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetric Departments in the Hospitals of Southern Denmark
City
Sønderborg
State/Province
Region South Denmark
Country
Denmark
12. IPD Sharing Statement
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Acupuncture for Pain Relief During Perineal Repair After Childbirth
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