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Correction of Breech Presentation With Laser Acupuncture

Primary Purpose

Breech Presentation

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation

Eligibility Criteria

20 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • uterus anomaly
  • uterus tumors
  • risk of preterm labor

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser acupuncture

No intervention

Arm Description

Laser acupuncture with knee-chest position

usual care with knee-chest position

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cephalic presentation at labor
confirmed by ultrasound

Full Information

First Posted
October 28, 2020
Last Updated
September 10, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04613778
Brief Title
Correction of Breech Presentation With Laser Acupuncture
Official Title
Correction of Breech Presentation With Laser Acupuncture: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture
Arm Type
Experimental
Arm Description
Laser acupuncture with knee-chest position
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
usual care with knee-chest position
Intervention Type
Procedure
Intervention Name(s)
Laser acupuncture
Intervention Description
Laser acupuncture is a low-level laser technique with no invasive procedure
Primary Outcome Measure Information:
Title
Cephalic presentation at gestation age (GA) of 36 weeks
Description
numbers of cephalic presentation confirmed by ultrasound
Time Frame
at gestation age (GA) 36 weeks
Secondary Outcome Measure Information:
Title
Cephalic presentation at labor
Description
confirmed by ultrasound
Time Frame
numbers of cephalic presentation at labor (an average of GA 38 weeks)
Other Pre-specified Outcome Measures:
Title
adverse events
Time Frame
through study completion, an average of 6 weeks
Title
preterm labor
Time Frame
through study completion, an average of 6 weeks
Title
methods of delivery
Description
C/S or vaginal delivery
Time Frame
at labor, an average of GA 38 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YEH YUAN-CHIEH
Phone
24313131
Ext
6321
Email
b9005030@cgmh.org.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
222
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YEH YUAN-CHIEH
Phone
24313131
Ext
6321
Email
b9005030@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Correction of Breech Presentation With Laser Acupuncture

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