Nitrous Oxide for External Cephalic Version
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|ClinicalTrials.gov Identifier: NCT03502915|
Recruitment Status : Completed
First Posted : April 19, 2018
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
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|Condition or disease||Intervention/treatment||Phase|
|External Cephalic Version||Drug: Nitrous Oxide Other: Placebo||Phase 3|
Potential subjects will be identified as they are scheduled to undergo ECV at the UNC Department of Obstetrics and Gynecology. Subjects will be enrolled in the study by one of the study investigators. Details of the study will be reviewed with potential subjects and those wishing to enroll in the study will be consented for the study by one of the study investigators. Once enrolled participants will be randomized to receive either a mixture of 50% nitrous oxide in 50% oxygen or 100% oxygen, both of which will be delivered via the Nitronox apparatus. Demographic variables will be recorded for each participant at the time they are enrolled in the study
The Nitronox apparatus will be set up to deliver either 50% nitrous oxide in 50% oxygen or 100% oxygen by an anesthesia provider covering labor and delivery who is not involved in the study. The Nitronox device will be covered to prevent participants, study investigators and obstetricians performing the procedure from knowing whether nitrous oxide is being delivered. Nitrous oxide is odorless and colorless, so in that way is indistinguishable from oxygen.
Participants will be prepared for ECV according to current protocols for ECV at UNC. IV access will be obtained and tocolytic agents will be given according to current practice and protocols. Monitoring of maternal and fetal vital signs will be done according to current protocols.
Immediately before an ECV attempt participants will breathe through the facemask of the Nitronox device for 30 seconds and will then be free to use the device ad lib during the ECV attempt. Immediately following each attempt, while fetal monitoring is occurring, the participants will be asked to rate their maximum pain score during the previous attempt. They will also be asked to rate their current level of anxiety. This process will be repeated for any further ECV attempts.
At conclusion of all ECV attempts, while fetal monitoring is occurring, the participants will be asked to rate their current level of pain, their satisfaction with the procedure and about any side effects they experienced (nausea, vomiting, dizziness, headache, other). Participants will continue to be monitored on labor and delivery as current protocol dictates, typically 30 minutes of maternal and fetal monitoring if there are no complications and fetal status is reassuring.
Following the procedure, the obstetrician who performed the procedure will be asked to rate how difficult they felt it was to perform the procedure and to rate how much they felt the analgesic provided assisted in performing the procedure. They will also be asked to indicate whether they thought the patient was in the treatment or placebo arm of the study. This will be recorded to address the adequacy of blinding.
All study variables will be assessed and recorded by one of the study investigators to ensure consistency in data collection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The Nitronox device will be covered. The person setting up the device with either 100% oxygen or 50% nitrous/50% oxygen, will not be participating in the study. The patient, investigator and labor and delivery personnel (obstetrician and nursing staff) will be blinded as to the medication being administered during the procedure.|
|Official Title:||Randomized Controlled Trial of Nitrous Oxide Analgesia in External Cephalic Version (ECV)|
|Actual Study Start Date :||January 30, 2017|
|Actual Primary Completion Date :||February 14, 2019|
|Actual Study Completion Date :||February 14, 2019|
Experimental: Nitrous Oxide
Patients will receive nitrous oxide during the version procedure.
Drug: Nitrous Oxide
50% nitrous oxide/50% oxygen via Nitronox delivery device
Other Name: Laughing gas
Placebo Comparator: Oxygen
Patients will receive placebo (100% oxygen) during the version procedure.
100% oxygen via Nitronox delivery device
- Mean Pain Score Experienced During Version [ Time Frame: During each version procedure, a total average of up to approximately 30 minutes ]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.
- Mean Anxiety Score Experienced During Version [ Time Frame: 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.
- Mean Post-procedure Pain Score [ Time Frame: 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.
- Mean Post-procedure Patient Satisfaction Score [ Time Frame: 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.
- Mean Post-procedure Provider Assessed Level of Difficulty Score [ Time Frame: 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Only females will participate because only females can be pregnant.|
|Accepts Healthy Volunteers:||Yes|
- Female 18 years or greater
- Scheduled to undergo external cephalic version due to singleton breech presentation
- Not scheduled to have spinal or epidural anesthesia during the version procedure
- American Society of Anesthesiology (ASA) Physical Status 1, 2 or 3.
- Able to provide informed consent and adhere to study protocol
- Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of exposure to nitrous oxide or complicate the subject's post-procedural course.
- Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502915
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Kathleen A. Smith, MD, FASA||University of North Carolina, Chapel Hill|
Documents provided by University of North Carolina, Chapel Hill:
|Responsible Party:||University of North Carolina, Chapel Hill|
|Other Study ID Numbers:||
|First Posted:||April 19, 2018 Key Record Dates|
|Results First Posted:||October 30, 2019|
|Last Update Posted:||October 30, 2019|
|Last Verified:||March 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||De-identified IPD for all primary and secondary outcome measures will be made available.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||9-36 months after publication|
|Access Criteria:||Approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
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