RecruitingNot ApplicableNCT06655675

Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART II)

Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART I and PART II)


Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Enrollment

54 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is measuring blood flow changes in the uterine and umbilical blood vessels before and after a spinal-epidural pain relief procedure (combined spinal-epidural analgesia, or CSE) during labor, to assess whether the pain relief affects blood flow to the baby. **You may be eligible if...** - You are a pregnant woman at term (full-term pregnancy) in active labor - You are requesting pain relief during labor - You have a single baby - You have no signs of fetal distress before the procedure - You may have a hypertensive disorder of pregnancy (this group is included) **You may NOT be eligible if...** - You are refusing to consent - Your baby shows signs of distress or heart rate abnormalities before the procedure - You have known fetal abnormalities - Your health status is too high risk for epidural analgesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUltrasound

Ultrasound scan of the umbilical artery


Locations(1)

Mount Sinai Hospital

Toronto, Ontario, Canada

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NCT06655675


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