Trial Outcomes & Findings for Nitrous Oxide for External Cephalic Version (NCT NCT03502915)

Last Updated: 2019-10-30

Results Overview

Pain scores will be collected following each version attempt using an 11 point scale (with 0 being no pain at all; 10 being worst pain imaginable), ranging from 0 to 10. Higher scores indicate more pain, lower scores indicate less pain. If more than one attempt, pain scores will be averaged to obtain a single score for the entire procedure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

48 participants

Primary outcome timeframe

During each version procedure, a total average of up to approximately 30 minutes

Results posted on

2019-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Nitrous Oxide Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device
Overall Study STARTED	24	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitrous Oxide for External Cephalic Version

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitrous Oxide n=24 Participants Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen n=24 Participants Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device	Total n=48 Participants Total of all reporting groups
Age, Continuous	32.5 years STANDARD_DEVIATION 4.7 • n=5 Participants	31.8 years STANDARD_DEVIATION 4.3 • n=7 Participants	32.1 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Baby Weight	3631.8 Grams STANDARD_DEVIATION 491.2 • n=5 Participants	3242.4 Grams STANDARD_DEVIATION 416.6 • n=7 Participants	3433.1 Grams STANDARD_DEVIATION 491 • n=5 Participants
Amniotic Fluid Index (AFI)	12.3 centimeters (cm) STANDARD_DEVIATION 4.5 • n=5 Participants	11.1 centimeters (cm) STANDARD_DEVIATION 4.2 • n=7 Participants	11.6 centimeters (cm) STANDARD_DEVIATION 4.3 • n=5 Participants
Gestational Age	37.1 Weeks STANDARD_DEVIATION 0.4 • n=5 Participants	37.2 Weeks STANDARD_DEVIATION 0.4 • n=7 Participants	37.1 Weeks STANDARD_DEVIATION 0.4 • n=5 Participants
BMI	29.3 Kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants	31 Kg/m^2 STANDARD_DEVIATION 6.3 • n=7 Participants	30.2 Kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: During each version procedure, a total average of up to approximately 30 minutes

Outcome measures

Outcome measures
Measure	Nitrous Oxide n=24 Participants Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen n=24 Participants Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device
Mean Pain Score Experienced During Version	5.486 score on a scale Standard Deviation 2.307	5.433 score on a scale Standard Deviation 2.695

SECONDARY outcome

Timeframe: During each version procedure, a total average of up to approximately 30 minutes

Anxiety scores will be collected following each version attempt using an 11 point scale (0 being not at all anxious; 10 being extremely anxious), ranging from 0 to 10. Higher scores indicate more anxiety, lower scores indicate less anxiety. If more than one attempt, anxiety scores will be averaged to obtain a single score for the entire procedure.

Outcome measures

Outcome measures
Measure	Nitrous Oxide n=24 Participants Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen n=24 Participants Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device
Mean Anxiety Score Experienced During Version	4.696 score on a scale Standard Deviation 2.969	4.253 score on a scale Standard Deviation 2.762

SECONDARY outcome

Timeframe: Immediately Post-procedure, within approximately 15 minutes of final version attempt

Pain scores will be collected following completion of the version using an 11 point scale (0 being no pain at all; 10 being worst pain imaginable), ranging from 0 to 10. Higher scores indicate more pain, lower scores indicate less pain.

Outcome measures

Outcome measures
Measure	Nitrous Oxide n=24 Participants Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen n=24 Participants Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device
Mean Post-procedure Pain Score	1 score on a scale Standard Deviation 1.155	0.88 score on a scale Standard Deviation 1.394

SECONDARY outcome

Timeframe: Immediately Post-procedure, within approximately 15 minutes of final version attempt

Satisfaction will be assessed following the procedure using an 11 point scale (0 being not at all satisfied; 10 being extremely satisfied), ranging from 0 to 10. Higher scores indicate more satisfaction, lower scores indicate less satisfaction.

Outcome measures

Outcome measures
Measure	Nitrous Oxide n=24 Participants Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen n=24 Participants Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device
Mean Post-procedure Patient Satisfaction Score	4.286 score on a scale Standard Deviation 4.027	6.920 score on a scale Standard Deviation 3.593

SECONDARY outcome

Timeframe: Immediately Post-procedure, within approximately 15 minutes of final version attempt

Following the procedure, the obstetric provider performing the procedure will rate the ease of procedure on a 1-10 scale (1 being very easy and 10 being extremely difficult), ranging from 1 to 10. Higher scores indicate more difficulty, lower scores indicate less difficulty. A 10 point scale was used for this outcome, while an 11 point scale was used for the other 4 outcome measures (pain, anxiety, post-procedure pain and satisfaction).

Outcome measures

Outcome measures
Measure	Nitrous Oxide n=24 Participants Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen n=24 Participants Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device
Mean Post-procedure Provider Assessed Level of Difficulty Score	6.136 score on a scale Standard Deviation 2.21	6.080 score on a scale Standard Deviation 3.187

Adverse Events

Nitrous Oxide

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Oxygen

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nitrous Oxide n=24 participants at risk Patients will receive nitrous oxide during the version procedure. Nitrous Oxide: 50% nitrous oxide/50% oxygen via Nitronox delivery device	Oxygen n=24 participants at risk Patients will receive placebo (100% oxygen) during the version procedure. Placebo: 100% oxygen via Nitronox delivery device
Gastrointestinal disorders Nausea	8.3% 2/24 • During each version procedure (or attempt), a total average of up to approximately 30 minutes and through approximately 15 minutes post-procedure following the final version attempt.	8.3% 2/24 • During each version procedure (or attempt), a total average of up to approximately 30 minutes and through approximately 15 minutes post-procedure following the final version attempt.
General disorders Transient headache	4.2% 1/24 • During each version procedure (or attempt), a total average of up to approximately 30 minutes and through approximately 15 minutes post-procedure following the final version attempt.	0.00% 0/24 • During each version procedure (or attempt), a total average of up to approximately 30 minutes and through approximately 15 minutes post-procedure following the final version attempt.
Nervous system disorders Dizziness	8.3% 2/24 • During each version procedure (or attempt), a total average of up to approximately 30 minutes and through approximately 15 minutes post-procedure following the final version attempt.	4.2% 1/24 • During each version procedure (or attempt), a total average of up to approximately 30 minutes and through approximately 15 minutes post-procedure following the final version attempt.

Additional Information

Kathleen A. Smith, MD

University of North Carolina at Chapel Hill

Phone: 9199665136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place