Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT02666794
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2015-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasmatic Catecholamines: Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Plasmatic Catecholamines After Neuraxial Labor Analgesia: a Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Combined spinal-epidural (CSE) for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, possibly due to asymmetric decrease in catecholamine levels, when compared with epidural analgesia (EP).
Detailed Description:
Background: Combined spinal-epidural technique for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, when compared with epidural analgesia, possibly due to asymmetric decrease in catecholamine levels (epinephrine and norepinephrine) following neuraxial block. However, there are no studies comparing plasmatic catecholamine levels between those two techniques. This study aimed to compare spinal-epidural versus epidural regarding pre and post-analgesia catecholamine levels, uterine tone and fetal heart rate.
Methods: Randomized clinical trial with 47 laboring patients divided in two groups. Primary outcome was plasmatic catecholamine measurements before and after neuraxial block. Secondary outcomes were fetal heart rate changes, uterine hypertonia, hypotension episodes, pain relief and fetal outcomes.
Methods: Randomized clinical trial with 47 laboring patients divided in two groups. Primary outcome was plasmatic catecholamine measurements before and after neuraxial block. Secondary outcomes were fetal heart rate changes, uterine hypertonia, hypotension episodes, pain relief and fetal outcomes.
Study Oversight
Has Oversight DMC:
True
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?: