Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498908
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Intracervical Balloon Placement With Nitrous Oxide Administration
Sponsor:
Maimonides Medical Center
Organization:
Maimonides Medical Center
Study Overview
Official Title:
Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration A Randomized Control Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled trial aims to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor
Detailed Description:
This is a single center randomized controlled trial aimed to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor Pregnant women requiring labor induction will be randomly assigned to receive either nitrous oxide or oxygen during the Foley balloon placement The primary outcome measured will be the success rate of the Foley balloon placement with secondary outcomes including patient comfort pain levels during the procedure and any adverse effects The study seeks to determine if nitrous oxide can improve the success rate of Foley balloon placement compared to oxygen and to evaluate the overall patient experience and safety associated with its use in this context
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None