ClinConnect ClinConnect Logo
Search / Trial NCT06655675

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

Launched by SAMUEL LUNENFELD RESEARCH INSTITUTE, MOUNT SINAI HOSPITAL · Oct 22, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Combined Spinal Epidural (Cse) Fetal Bradycardia Ultrasound Velocimetric Index Hypertension

ClinConnect Summary

This clinical trial is investigating how a specific type of pain relief called combined spinal-epidural (CSE) affects blood flow in pregnant women during labor. CSE is commonly used for quick pain relief, but it can sometimes lead to changes in the baby's heart rate. Researchers want to understand if CSE reduces blood flow in the mother's uterine artery and the baby's umbilical artery, which might explain why some babies experience a slower heart rate after this type of pain relief.

To participate in this study, women must be at least 18 years old, be in active labor with a single baby due for delivery, and be requesting pain relief. They should not have any major health issues or fetal problems before receiving the CSE. Participants will be monitored using a special ultrasound that checks blood flow before and after the CSE is given. This research aims to help doctors understand how CSE affects both the mother and the baby during labor, providing better care for mothers and their newborns.

Gender

FEMALE

Eligibility criteria

  • 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

About Samuel Lunenfeld Research Institute, Mount Sinai Hospital

The Samuel Lunenfeld Research Institute at Mount Sinai Hospital is a leading biomedical research facility dedicated to advancing our understanding of human health and disease. Renowned for its innovative research programs, the institute focuses on areas such as cancer, genetics, and reproductive health, fostering collaboration among top-tier scientists and clinicians. With a commitment to translating research findings into clinical applications, the Samuel Lunenfeld Research Institute plays a pivotal role in the development of novel therapies and interventions, thereby contributing to improved patient outcomes and the advancement of medical science.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported