Correction of Breech Presentation With Laser Acupuncture | NCT04613778

Studies
Correction of Breech Presentation With Laser Acupuncture

NCT04613778

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Breech Presentation

Interventions

Laser acupuncture

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 28, 2020

First Submission Date that Met QC Criteria

Nov 1, 2020

First Posted Date

Nov 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The aim of this study is to evaluate the effectiveness and safety of laser acupuncture in correcting breech presentation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser acupuncture	Experimental	Laser acupuncture with knee-chest position	Procedure: Laser acupuncture
No intervention	No Intervention	usual care with knee-chest position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser acupuncture	Procedure	Laser acupuncture is a low-level laser technique with no invasive procedure	Laser acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cephalic presentation at gestation age (GA) of 36 weeks	numbers of cephalic presentation confirmed by ultrasound	at gestation age (GA) 36 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cephalic presentation at labor	confirmed by ultrasound	numbers of cephalic presentation at labor (an average of GA 38 weeks)

Other Outcomes

Measure	Description	Time Frame
adverse events		through study completion, an average of 6 weeks
preterm labor		through study completion, an average of 6 weeks
methods of delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breech presentation or non-cephalic presentation
gestation age 28~34 weeks
singleton

Exclusion Criteria:

uterus anomaly
uterus tumors
risk of preterm labor

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

36 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YEH YUAN-CHIEH	Contact	24313131	6321	b9005030@cgmh.org.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital	Recruiting	Keelung		222	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001946	Breech Presentation

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided