NCT00328796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

October 6, 2008

Status Verified

September 1, 2008

Enrollment Period

1.2 years

First QC Date

May 19, 2006

Last Update Submit

October 3, 2008

Conditions

Birth InjuriesLacerationsPain

Keywords

Perinealrepairepisiotomiesmidwivespain reliefEpisiotomy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Patient satisfaction with the given pain relief

Interventions

acupuncture in 6 specific pointsPROCEDURE
lidocaine 10mg/mlDRUG

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primipara
  • Healthy mother and child
  • Danish speaking
  • Perineal laceration or episiotomy that can be sutured by a midwife.

You may not qualify if:

  • Large perineal lacerations
  • Heavy bleeding after childbirth
  • No need for pain relief

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetric Departments in the Hospitals of Southern Denmark

Sønderborg, Region Syddanmark, Denmark

Location

MeSH Terms

Conditions

Birth InjuriesLacerationsPain

Interventions

Acupuncture TherapyLidocaine

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Sara Kindberg, PhD Student

    Aarhus University, Perinatal Epidemiological Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2007

Study Completion

February 1, 2008

Last Updated

October 6, 2008

Record last verified: 2008-09

Locations

DK(1)