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Acupuncture for Pain Relief During Perineal Repair After Childbirth

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00328796
Enrollment
207
Registered
2006-05-22
Start date
2006-05-31
Completion date
2008-02-29
Last updated
2008-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Injuries, Lacerations, Pain

Keywords

Perineal, repair, episiotomies, midwives, pain relief, Episiotomy

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: 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. 4. Patient satisfaction with the given pain relief.

Interventions

PROCEDUREacupuncture in 6 specific points

Sponsors

The Danish Midwifery Organization
CollaboratorUNKNOWN
Aase and Ejnar Danielsens Foundation
CollaboratorOTHER
The Augustinus Foundation, Denmark.
CollaboratorOTHER
Sonderborg Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
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

Design outcomes

Primary

MeasureTime 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

Secondary

MeasureTime frame
Patient satisfaction with the given pain relief

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026