Viewing Study NCT06655675



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06655675
Status: RECRUITING
Last Update Posted: None
First Post: 2024-10-17

Brief Title: Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women PART II
Sponsor: None
Organization: None

Study Overview

Official Title: Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women PART I and PART II
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
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 used for many years and is practiced commonly at our institution especially when the patient requests immediate pain relief CSE is not only beneficial for its faster onset of analgesia but also it is favorable in relation to the need for rescue analgesia urinary retention and rate of instrumental delivery compared to the traditional epidural Despite its beneficial effects there is a risk of about 15-30 of developing abnormal fetal heart rate following CSE This is self-resolving with minimal or no intervention Although the cause of fetal bradycardia is not fully elucidated variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations fluid administration maternal hypotension uterine vascular effects of sympathetic block fluctuations in circulating catecholamines and possibly the effect of opioids Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block

Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery UtA and fetal umbilical artery UmA velocity waveforms to detect changes in blood flow The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE Thus the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships

The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE which may be responsible for the occurrence of fetal bradycardia
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None