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Correction of Breech Presentation With Laser Acupuncture

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04613778
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
34.4
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laser acupuncture
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Correction of Breech Presentation With Laser Acupuncture: a Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Apr 15, 2023
Anticipated Study Completion Date :
Apr 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Laser acupuncture

Laser acupuncture with knee-chest position

Procedure: Laser acupuncture
Laser acupuncture is a low-level laser technique with no invasive procedure
No Intervention: No intervention

usual care with knee-chest position

Outcome Measures

Primary Outcome Measures

  1. Cephalic presentation at gestation age (GA) of 36 weeks [at gestation age (GA) 36 weeks]

    numbers of cephalic presentation confirmed by ultrasound

Secondary Outcome Measures

  1. Cephalic presentation at labor [numbers of cephalic presentation at labor (an average of GA 38 weeks)]

    confirmed by ultrasound

Other Outcome Measures

  1. adverse events [through study completion, an average of 6 weeks]

  2. preterm labor [through study completion, an average of 6 weeks]

  3. methods of delivery [at labor, an average of GA 38 weeks]

    C/S or vaginal delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 36 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • breech presentation or non-cephalic presentation

  • gestation age 28~34 weeks

  • singleton

Exclusion Criteria:

  • uterus anomaly

  • uterus tumors

  • risk of preterm labor

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Gung Memorial Hospital Keelung Taiwan 222

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04613778
Other Study ID Numbers:
  • 202000341A3
First Posted:
Nov 3, 2020
Last Update Posted:
Aug 6, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breech Presentation

Study Results

No Results Posted as of Aug 6, 2021