Breech PresentationNCT04613778
Correction of Breech Presentation With Laser Acupuncture
A study testing Laser acupuncture in people with Breech Presentation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Acupuncture-type interventions (such as moxibustion and acupuncture) at Bladder 67 (BL67, Zhiyin point) have been proposed to have positive effects on breech presentation. However, the role of laser acupuncture for Breech presentation remains unknown. Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Laser acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2020to 31 Dec 2024
- 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 20 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- breech presentation or non-cephalic presentation
- gestation age 28~34 weeks
- singleton
Who cannot join
- uterus anomaly
- uterus tumors
- risk of preterm labor
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Keelung, 222
YEH YUAN-CHIEH, 24313131 ext. 6321, b9005030@cgmh.org.tw
About this study
Official title: Correction of Breech Presentation With Laser Acupuncture: a Randomized Controlled Trial
Acupuncture-type interventions (such as moxibustion and acupuncture) at Bladder 67 (BL67, Zhiyin point) have been proposed to have positive effects on breech presentation. However, the role of laser acupuncture for Breech presentation remains unknown. The aim of this study is to evaluate the effectiveness and safety of laser acupuncture in correcting breech presentation.
- Conditions
- Breech Presentation
- Being tested
- Laser acupuncture
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureProcedure or surgery
Laser acupuncture is a low-level laser technique with no invasive procedure
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture | Experimental | Laser acupuncture with knee-chest position Receives: Procedure: Laser acupuncture |
| No intervention | No intervention | usual care with knee-chest position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalic presentation at gestation age (GA) of 36 weeks
numbers of cephalic presentation confirmed by ultrasound
Measured: at gestation age (GA) 36 weeks
Secondary outcomes (1)
Cephalic presentation at labor
confirmed by ultrasound
Measured: numbers of cephalic presentation at labor (an average of GA 38 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Jun 2020
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613778
- Sponsor's protocol ID
- 202000341A3
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Breech Presentation With Laser Acupuncture: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04613778
- Acronym / sponsor ID
- 202000341A3
- Conditions
- Breech Presentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Nov 2020 (actual)
- 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.
Acupuncture-type interventions (such as moxibustion and acupuncture) at Bladder 67 (BL67, Zhiyin point) have been proposed to have positive effects on breech presentation. However, the role of laser acupuncture for Breech presentation remains unknown. The aim of this study is to evaluate the effectiveness and safety of laser acupuncture in correcting breech presentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture | Experimental | Procedure: Laser acupunctureLaser acupuncture with knee-chest position |
| No intervention | No intervention | –usual care with knee-chest position |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- breech presentation or non-cephalic presentation
- gestation age 28~34 weeks
- singleton
Key exclusion criteria (3 listed)
- uterus anomaly
- uterus tumors
- risk of preterm labor
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 |
|---|---|---|
| Laser acupunctureLaser acupuncture is a low-level laser technique with no invasive procedure | Procedure or surgery | Laser acupuncture |
Primary outcome
Cephalic presentation at gestation age (GA) of 36 weeks
Time frame: at gestation age (GA) 36 weeks
numbers of cephalic presentation confirmed by ultrasound
1 secondary outcome
Cephalic presentation at labor
Time frame: numbers of cephalic presentation at labor (an average of GA 38 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture in people with Breech Presentation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YEH YUAN-CHIEH (24313131 ext. 6321, b9005030@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cephalic presentation at gestation age (GA) of 36 weeks (time frame: at gestation age (GA) 36 weeks). 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 13 Sep 2023; AzTrials last refreshed its copy on 3 Nov 2026.