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| Name | Class |
|---|---|
| The Danish Midwifery Organization | UNKNOWN |
| Aase and Ejnar Danielsens Foundation | OTHER |
| The Augustinus Foundation, Denmark. | OTHER |
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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture in 6 specific points | Procedure | |||
| lidocaine 10mg/ml | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with the given pain relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Kindberg, PhD Student | Aarhus University, Perinatal Epidemiological Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetric Departments in the Hospitals of Southern Denmark | Sønderborg | Region Syddanmark | Denmark |
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| ID | Term |
|---|---|
| D001720 | Birth Injuries |
| D022125 | Lacerations |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D000083 | Acetanilides |
| D000813 | Anilides |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |