PainNCT01165099
Acupuncture for Pain Relief During Induced Labour in Nulliparae
A study testing acupuncture in people with Pain, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- acupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2005to Jul 2009
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nulliparae
- having labour induced for prolonged pregnancy or mild hypertension
- no previous experience of acupuncture
- give written informed consent
Who cannot join
- all who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture for Pain Relief During Induced Labour in Nulliparae: a Randomised Controlled Study
The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition.
Read the detailed description
The study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. The study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.
- Conditions
- Pain
- Being tested
- acupuncture
- Keywords
- acupuncture, induced labour, labour outcome, nulliparae, pain-relief, epidural during labour
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Also called Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm., Electronic Acupunctuscope AWQ-104L digital.
The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.
| Study group | Role | What they receive |
|---|---|---|
| manual acupuncture | Experimental | Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were manually manipulated during this time. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used. Receives: Procedure: acupuncture |
| electro acupuncture | Experimental | Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were either electronically simulated withm2 Hz pulses of 0.5 msec duration for 30 minutes sufficient to cause non-painful muscle contractions. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used. Receives: Procedure: acupuncture |
| Sham manual or electro acupuncture | Sham comparator | Sterile needles were inserted adjacent to the specific acupuncture sites identified for the manual and electro groups to a depth of 1-1.5mm only and insufficient to provoke an unusual sensation and left in position for a 30-60 minutes. Those randomised to 'sham-manual' received no stimulation and those randomised to 'sham-electro' were connected to the electrical stimulator but the current not activated. Receives: Procedure: acupuncture |
| control group | No intervention | Following randomisation to be control group, no specific treatment was organised at this time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of intrapartum epidural analgesia
epidural analgesia administered during labour
Measured: within 72 hours of trial entry
Secondary outcomes (1)
the outcome of labour
the outcomes of labour included: parenteral analgesia requirement, labour length, delivery mode, neonatal condition and postpartum haemorrhage
Measured: within 72 hours of trial entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startAug 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Mackenzie, University of Oxford
- Investigators
- I Z MacKenzie, FRCOG, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165099
- Sponsor's protocol ID
- 4874
- Status last verified
- Apr 2019
- First submitted
- 15 Jul 2010
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee H, Ernst E. Acupuncture for labor pain management: A systematic review. Am J Obstet Gynecol. 2004 Nov;191(5):1573-9. doi: 10.1016/j.ajog.2004.05.027.
PubMed 15547526Mackenzie IZ, Xu J, Cusick C, Midwinter-Morten H, Meacher H, Mollison J, Brock M. Acupuncture for pain relief during induced labour in nulliparae: a randomised controlled study. BJOG. 2011 Mar;118(4):440-7. doi: 10.1111/j.1471-0528.2010.02825.x. Epub 2011 Jan 18.
PubMed 21244615
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Pain Relief During Induced Labour in Nulliparae: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01165099
- Acronym / sponsor ID
- 4874
- Conditions
- Pain
- Keywords
- acupuncture, induced labour, labour outcome, nulliparae, pain-relief, epidural during labour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Jul 2010 (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.
The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition.
Detailed description
The study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. The study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| manual acupuncture | Experimental | Procedure: acupunctureSterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were manually manipulated during this time. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used. |
| electro acupuncture | Experimental | Procedure: acupunctureSterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were either electronically simulated withm2 Hz pulses of 0.5 msec duration for 30 minutes sufficient to cause non-painful muscle contractions. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used. |
| Sham manual or electro acupuncture | Sham comparator | Procedure: acupunctureSterile needles were inserted adjacent to the specific acupuncture sites identified for the manual and electro groups to a depth of 1-1.5mm only and insufficient to provoke an unusual sensation and left in position for a 30-60 minutes. Those randomised to 'sham-manual' received no stimulation and those randomised to 'sham-electro' were connected to the electrical stimulator but the current not activated. |
| control group | No intervention | –Following randomisation to be control group, no specific treatment was organised at this time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- nulliparae
- having labour induced for prolonged pregnancy or mild hypertension
- no previous experience of acupuncture
- give written informed consent
Key exclusion criteria (1 listed)
- all who do not meet the inclusion criteria
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 |
|---|---|---|
| acupunctureAlso: Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm., Electronic Acupunctuscope AWQ-104L digital.The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups. | Procedure or surgery | Sham manual or electro acupuncture, electro acupuncture, manual acupuncture |
Primary outcome
the rate of intrapartum epidural analgesia
Time frame: within 72 hours of trial entry
epidural analgesia administered during labour
1 secondary outcome
the outcome of labour
Time frame: within 72 hours of trial entry
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 30 Apr 2019.
- Background: PubMed 15547526Lee H, Ernst E. Acupuncture for labor pain management: A systematic review. Am J Obstet Gynecol. 2004 Nov;191(5):1573-9. doi: 10.1016/j.ajog.2004.05.027.
- Results publication: PubMed 21244615Mackenzie IZ, Xu J, Cusick C, Midwinter-Morten H, Meacher H, Mollison J, Brock M. Acupuncture for pain relief during induced labour in nulliparae: a randomised controlled study. BJOG. 2011 Mar;118(4):440-7. doi: 10.1111/j.1471-0528.2010.02825.x. Epub 2011 Jan 18.
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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.
I Z MacKenzie, FRCOG principal investigator
University of Oxford
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 people with Pain, run by University of Oxford at 1 site in United Kingdom.
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 1 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 30 Apr 2019. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
the rate of intrapartum epidural analgesia (time frame: within 72 hours of trial entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165099, which also lists 2 linked publications.
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 30 Apr 2019.