Acupuncture for Pain Relief During Perineal Repair After Childbirth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Birth Injuries Lacerations Pain

Keywords

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Perineal repair episiotomies midwives pain relief Episiotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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acupuncture in 6 specific points

Intervention Type PROCEDURE

lidocaine 10mg/ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Sara Kindberg, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Perinatal Epidemiological Unit

Locations

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Obstetric Departments in the Hospitals of Southern Denmark

Sønderborg, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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11295

Identifier Type: -

Identifier Source: org_study_id