Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 1:18 PM
Study NCT ID:
NCT03797833
Status:
SUSPENDED
Last Update Posted:
2022-10-27
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Anesthesia for External Cephalic Version
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study
Status:
SUSPENDED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow inclusion rate. Central contact person quit for another job.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.
Detailed Description:
Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.
The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.
The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.
The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.
The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: