Birth InjuriesNCT00328796
Acupuncture for Pain Relief During Perineal Repair After Childbirth
A study testing acupuncture in 6 specific points and lidocaine 10mg/ml in people with Birth Injuries and Lacerations, run by Sonderborg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Birth Injuries, Lacerations, Pain
- What is being tested?
- acupuncture in 6 specific points and lidocaine 10mg/ml
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- 1 siteDenmark
- Study dates
- May 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primipara
- Healthy mother and child
- Danish speaking
- Perineal laceration or episiotomy that can be sutured by a midwife.
Who cannot join
- Large perineal lacerations
- Heavy bleeding after childbirth
- No need for pain relief
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Obstetric Departments in the Hospitals of Southern Denmark
Sønderborg, Region Syddanmark
About this study
Official title: Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Birth Injuries, Lacerations, Pain
- Being tested
- acupuncture in 6 specific points, lidocaine 10mg/ml
- Keywords
- Perineal, repair, episiotomies, midwives, pain relief, Episiotomy
- Medical subject headings
- Birth Injuries, Lacerations, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture in 6 specific pointsProcedure or surgery
lidocaine 10mg/mlDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonderborg Hospital
- Sponsor type
- Other government
- Collaborators
- The Danish Midwifery Organization, Aase and Ejnar Danielsens Foundation, The Augustinus Foundation, Denmark.
- Investigators
- Sara Kindberg, PhD Student, Principal investigator, Aarhus University, Perinatal Epidemiological Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328796
- Sponsor's protocol ID
- 11295
- Status last verified
- Sep 2008
- First submitted
- 19 May 2006
- Last updated
- 6 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00328796
- Acronym / sponsor ID
- 11295
- Conditions
- Birth Injuries, Lacerations, Pain
- Keywords
- Perineal, repair, episiotomies, midwives, pain relief, Episiotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Sonderborg HospitalOther government
- Collaborators
- The Danish Midwifery Organization, Aase and Ejnar Danielsens Foundation, The Augustinus Foundation, Denmark.
- Study start
- May 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Primipara
- Healthy mother and child
- Danish speaking
- Perineal laceration or episiotomy that can be sutured by a midwife.
Key exclusion criteria (3 listed)
- Large perineal lacerations
- Heavy bleeding after childbirth
- No need for pain relief
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture in 6 specific points | Procedure or surgery | – |
| lidocaine 10mg/ml | Drug | – |
Primary outcome
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
1 secondary outcome
Patient satisfaction with the given pain relief
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Kindberg, PhD Student principal investigator
Aarhus University, Perinatal Epidemiological Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in 6 specific points and lidocaine 10mg/ml in people with Birth Injuries and Lacerations, run by Sonderborg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for additional pain relief during the perineal repair. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2008.