Recruiting

Combined Spinal-epidural Analgesia

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06655675

Conditions

Labor Pain

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Ultrasound

Study Details

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.

Conditions

Labor Pain

Study ID

NCT06655675

Start date

Oct 30, 2024

Status verified date

Jul, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Ultrasound - patients without hypertensive disorders of pregnancy

Ultrasound will be used to measure velocimetric index of the umbilical artery.

experimental: Ultrasound - patients with diagnosed hypertensive disorders of pregnancy

Ultrasound will be used to measure velocimetric index of the umbilical artery.

Interventions

Ultrasound

Ultrasound scan of the umbilical artery

Primary outcome measure

  • Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes [ Time Frame: 10 minutes ]
  • Umbilical artery velocimetric index - pulsatility index (PI) at 10 minutes [ Time Frame: 10 minutes ]
  • Umbilical artery velocimetric index - resistance index (RI) at 10 minutes [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Jul 11, 2025

Last verified

Jul, 2025

Keywords

  • combined spinal epidural (CSE)
  • fetal bradycardia
  • ultrasound
  • velocimetric index
  • hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2025-07-11.