DystociaPhase 2NCT00279071
Use of Acupuncture for Stimulation of Labour
A Phase 2 study testing Acupuncture og acupressure when diagnosed with dystocia in people with Dystocia, run by Herning Hospital.
Trial summary
Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia. A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dystocia
- What is being tested?
- Acupuncture og acupressure when diagnosed with dystocia
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Mar 2007
- Phase
- Phase 2
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal pregnancy
- In labour (orificium < 8 cm), 37th week or thereafter
- Ruptured membranes
- Primary or secondary inertia -
Who cannot join
- Pathological pregnancy
- Pathological labour
- Medical diseases
- Women who do not speak and undrestand danish
About this study
Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia.
A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture.
Read more
The women are randomized into to groups.
- Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)
- No treatment
The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial.
Inclusion criteria:
- Normal pregnancy
- In labour (orificium < 8 cm), 37th week or thereafter
- Ruptured membranes
- Primary or secondary inertia
The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization.
The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration.
Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice:
- before the randomization and again 1 hour after randomization.
- Conditions
- Dystocia
- Being tested
- Acupuncture og acupressure when diagnosed with dystocia
- Keywords
- dystocia, stimulation, acupuncture, oxytocin
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture og acupressure when diagnosed with dystociaDevice
Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startOct 2002
- Study completionMar 2007
Why it stopped: exhausted personel after a long recruiting period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystociaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ringkjøbing County Research Fond, Union of Midwives Research Fond
- Investigators
- Kjeld Rasmussen, obst. dr.med, Study chair, Obstetric ward Herning and Holstebro hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279071
- Sponsor's protocol ID
- 1-Modlock
- Other IDs
- NCT00279071
- Status last verified
- Jul 2008
- First submitted
- 18 Jan 2006
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Acupuncture for Stimulation of Labour
- ClinicalTrials.gov ID
- NCT00279071
- Acronym / sponsor ID
- 1-Modlock
- Conditions
- Dystocia
- Keywords
- dystocia, stimulation, acupuncture, oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: exhausted personel after a long recruiting period
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Collaborators
- Ringkjøbing County Research Fond, Union of Midwives Research Fond
- Study start
- Oct 2002
- Study completion
- Mar 2007 (actual)
- First posted
- 19 Jan 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.
Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia.
A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture.
The women are randomized into to groups.
- Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)
- No treatment
The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial.
Inclusion criteria:
- Normal pregnancy
- In labour (orificium < 8 cm), 37th week or thereafter
- Ruptured membranes
- Primary or secondary inertia
The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization.
The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration.
Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice:
- before the randomization and again 1 hour after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Normal pregnancy
- In labour (orificium < 8 cm), 37th week or thereafter
- Ruptured membranes
- Primary or secondary inertia -
Key exclusion criteria (4 listed)
- Pathological pregnancy
- Pathological labour
- Medical diseases
- Women who do not speak and undrestand danish
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 og acupressure when diagnosed with dystociaAcupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67 | Device | – |
Primary outcome
Not reported in the source record.
2 secondary outcomes
use of oxytocin
Time frame: additional need for oxytocin infusion in 1. stage and 2. stage
number of contractions/30 minutes
Time frame: number og contractions in 1st. stage and 2nd. stage
Results and safety
The study was stopped early (reason given: exhausted personel after a long recruiting period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
Related trials for Dystocia
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Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
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Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
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.
Kjeld Rasmussen, obst. dr.med study chair
Obstetric ward Herning and Holstebro hospitals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture og acupressure when diagnosed with dystocia in people with Dystocia, run by Herning Hospital.
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 4 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: stopped early, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: exhausted personel after a long recruiting period). Results are not available in the source record.
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.
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 4 Jul 2008.