NCT04613778

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 13, 2023

Status Verified

August 1, 2023

Enrollment Period

4.4 years

First QC Date

October 28, 2020

Last Update Submit

September 10, 2023

Conditions

Breech Presentation

Outcome Measures

Primary Outcomes (1)

  • Cephalic presentation at gestation age (GA) of 36 weeks

    numbers of cephalic presentation confirmed by ultrasound

    at gestation age (GA) 36 weeks

Secondary Outcomes (1)

  • Cephalic presentation at labor

    numbers of cephalic presentation at labor (an average of GA 38 weeks)

Other Outcomes (3)

  • adverse events

    through study completion, an average of 6 weeks

  • preterm labor

    through study completion, an average of 6 weeks

  • methods of delivery

    at labor, an average of GA 38 weeks

Study Arms (2)

Laser acupuncture

EXPERIMENTAL

Laser acupuncture with knee-chest position

Procedure: Laser acupuncture

No intervention

NO INTERVENTION

usual care with knee-chest position

Interventions

Laser acupuncturePROCEDURE

Laser acupuncture is a low-level laser technique with no invasive procedure

Laser acupuncture

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • uterus anomaly
  • uterus tumors
  • risk of preterm labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, 222, Taiwan

RECRUITING

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

YEH YUAN-CHIEH

CONTACT

24313131b9005030@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 3, 2020

Study Start

June 1, 2020

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

September 13, 2023

Record last verified: 2023-08

Locations

TW(1)