Trial Outcomes & Findings for Moxibustion in a Randomized Trial for Version of Breech Position From Week 32 (NCT NCT02251886)

NCT ID: NCT02251886

Last Updated: 2017-03-03

Results Overview

Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2017-03-03

Participant Flow

Participant milestones

Measure	Moxibustion in Primiparae Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae	Moxibustion in Multiparae Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae	Control Primiparae No intervention. Routine control schedule for primiparae with midwife	Control Multiparae No intervention. Routine control schedule for multiparae with midwife
Overall Study STARTED	48	54	44	54
Overall Study COMPLETED	48	54	44	54
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Moxibustion in a Randomized Trial for Version of Breech Position From Week 32

Baseline characteristics by cohort

Measure	Moxibustion in Primiparae n=48 Participants Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae	Moxibustion in Multiparae n=54 Participants Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae	Control Primiparae n=44 Participants No intervention. Routine control schedule for primiparae with midwife	Control Multiparae n=54 Participants No intervention. Routine control schedule for multiparae with midwife	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	54 Participants n=7 Participants	44 Participants n=5 Participants	54 Participants n=4 Participants	200 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	28 years STANDARD_DEVIATION 4 • n=5 Participants	31 years STANDARD_DEVIATION 3 • n=7 Participants	29 years STANDARD_DEVIATION 4 • n=5 Participants	31 years STANDARD_DEVIATION 3 • n=4 Participants	30 years STANDARD_DEVIATION 4 • n=21 Participants
Gender Female	48 Participants n=5 Participants	54 Participants n=7 Participants	44 Participants n=5 Participants	54 Participants n=4 Participants	200 Participants n=21 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Denmark	48 participants n=5 Participants	54 participants n=7 Participants	44 participants n=5 Participants	54 participants n=4 Participants	200 participants n=21 Participants
Weight	76 kg STANDARD_DEVIATION 14 • n=5 Participants	78 kg STANDARD_DEVIATION 14 • n=7 Participants	75 kg STANDARD_DEVIATION 12 • n=5 Participants	74 kg STANDARD_DEVIATION 15 • n=4 Participants	76 kg STANDARD_DEVIATION 14 • n=21 Participants
Gestational age	229 days STANDARD_DEVIATION 6 • n=5 Participants	230 days STANDARD_DEVIATION 6 • n=7 Participants	230 days STANDARD_DEVIATION 7 • n=5 Participants	231 days STANDARD_DEVIATION 7 • n=4 Participants	230 days STANDARD_DEVIATION 6 • n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment

Outcome measures

Measure	Moxibustion in Primiparae n=48 Participants Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae	Moxibustion in Multiparae n=54 Participants Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae	Control Primiparae n=44 Participants No intervention. Routine control schedule for primiparae with midwife	Control Multiparae n=54 Participants No intervention. Routine control schedule for multiparae with midwife
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment	34 participants	25 participants	34 participants	25 participants

Adverse Events

Moxibustion in Primiparae

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moxibustion in Multiparae

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Primiparae

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Multiparae

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Finn Lauszus

Herning Hospital

Phone: +45 78434614

Email: finlau@rm.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place