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NCT06655675Recruiting

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)

Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
54 (estimated)
First submitted
17 Oct 2024
Start date
30 Oct 2024
Primary completion date
Jan 2026
Lead sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
NCT number
NCT06655675

What you commit to

  • Study type: Interventional
  • Planned participants: 54
  • From 30 Oct 2024 to the primary completion date, Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous back instrumentation

Other

  • Refusal to consent for the study
  • Known spinal deformities
  • Patients with BMI\>50 kg/㎡ due to anticipated technical challenges in Doppler studies

Who the study is looking for

  • Written informed consent
  • Term pregnant patients requesting labor analgesia
  • Singleton pregnancy
  • Term pregnant patients in active labor
  • ASA\<4
  • No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE
  • Patients with and without diagnosed hypertensive disorders of pregnancy

Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Mount Sinai Hospital
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.