Nitrous Oxide for External Cephalic Version

NCT03502915 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 16-1569
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine the effectiveness of nitrous oxide in reducing the anxiety and pain associated with external cephalic version (ECV); a maneuver to turn the fetus from breech to cephalic position.

Conditions

External Cephalic Version

Keywords

breech presentation; nitrous oxide; analgesia; pregnancy

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score Experienced During Version

  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.

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

Secondary Outcomes (4)

• Mean Anxiety Score Experienced During Version

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

• Mean Post-procedure Pain Score

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

• Mean Post-procedure Patient Satisfaction Score

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

• Mean Post-procedure Provider Assessed Level of Difficulty Score

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

Study Arms (2)

Nitrous Oxide

EXPERIMENTAL

Patients will receive nitrous oxide during the version procedure.

Drug: Nitrous Oxide

Oxygen

PLACEBO COMPARATOR

Patients will receive placebo (100% oxygen) during the version procedure.

Other: Placebo

Interventions

Nitrous Oxide DRUG

50% nitrous oxide/50% oxygen via Nitronox delivery device

Also known as: Laughing gas

Nitrous Oxide

Placebo OTHER

100% oxygen via Nitronox delivery device

Oxygen

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females will participate because only females can be pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (11)

• Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83. doi: 10.1016/s0140-6736(00)02840-3.

  PMID: 11052579 BACKGROUND

• ACOG Committee on Obstetric Practice. ACOG Committee Opinion No. 340. Mode of term singleton breech delivery. Obstet Gynecol. 2006 Jul;108(1):235-7. doi: 10.1097/00006250-200607000-00058.

  PMID: 16816088 BACKGROUND

• Fok WY, Chan LW, Leung TY, Lau TK. Maternal experience of pain during external cephalic version at term. Acta Obstet Gynecol Scand. 2005 Aug;84(8):748-51. doi: 10.1111/j.0001-6349.2005.00505.x.

  PMID: 16026399 BACKGROUND

• Lavoie A, Guay J. Anesthetic dose neuraxial blockade increases the success rate of external fetal version: a meta-analysis. Can J Anaesth. 2010 May;57(5):408-14. doi: 10.1007/s12630-010-9278-4. Epub 2010 Feb 3.

  PMID: 20127530 BACKGROUND

• Weiniger CF, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. doi: 10.1097/01.AOG.0000295605.38175.7b.

  PMID: 18055730 BACKGROUND

• Likis FE, Andrews JC, Collins MR, Lewis RM, Seroogy JJ, Starr SA, Walden RR, McPheeters ML. Nitrous oxide for the management of labor pain: a systematic review. Anesth Analg. 2014 Jan;118(1):153-67. doi: 10.1213/ANE.0b013e3182a7f73c.

  PMID: 24356165 BACKGROUND

• Rosen MA. Nitrous oxide for relief of labor pain: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S110-26. doi: 10.1067/mob.2002.121259.

  PMID: 12011877 BACKGROUND

• Creeley CE, Olney JW. The young: neuroapoptosis induced by anesthetics and what to do about it. Anesth Analg. 2010 Feb 1;110(2):442-8. doi: 10.1213/ANE.0b013e3181c6b9ca. Epub 2009 Dec 2.

  PMID: 19955510 BACKGROUND

• Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.

  PMID: 12574416 BACKGROUND

• Schnabel A, Hahn N, Broscheit J, Muellenbach RM, Rieger L, Roewer N, Kranke P. Remifentanil for labour analgesia: a meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2012 Apr;29(4):177-85. doi: 10.1097/EJA.0b013e32834fc260.

  PMID: 22273829 BACKGROUND

• Munoz H, Guerra S, Perez-Vaquero P, Valero Martinez C, Aizpuru F, Lopez-Picado A. Remifentanil versus placebo for analgesia during external cephalic version: a randomised clinical trial. Int J Obstet Anesth. 2014 Feb;23(1):52-7. doi: 10.1016/j.ijoa.2013.07.006. Epub 2014 Jan 3.

  PMID: 24388737 BACKGROUND

Related Links

• Lancet 2000 CD versus breech VD
• ACOG committee opinion 340
• Neuraxial for version
• Neuraxial for version
• Nitrous for labor pain
• nitrous for labor pain
• Neuroapoptosis
• anesthetic gases and apoptosis
• remi for labor analgesia

MeSH Terms

Conditions

Breech Presentation; Agnosia

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Kathleen A. Smith, MD
• Organization: University of North Carolina at Chapel Hill

ksmith@aims.unc.edu

9199665136

Study Officials

• Kathleen A. Smith, MD, FASA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: January 30, 2017
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.

Locations

US (1)