Actively Recruiting
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART I and PART II)
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2025-07-11
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how combined spinal-epidural (CSE) analgesia affects blood flow in the uterine and umbilical arteries of women in labor. This study focuses on understanding the possible causes of fetal heart rate changes, such as fetal bradycardia, which can occur in 15-30% of cases after CSE. The aim is to evaluate maternal and fetal blood flow changes before and after CSE, using ultrasound measurements of velocimetric indices. The study involves using ultrasound scans to measure blood flow in the umbilical artery at various times before and after CSE analgesia during labor. Participants include women in active labor with singleton pregnancies, both with and without hypertensive disorders. The blood flow will be monitored at baseline, and then at 5, 10, 20, and 30 minutes after CSE administration. The study is non-randomized and open-label. Participants will undergo ultrasound evaluations to assess blood flow changes and complete pain score questionnaires at set intervals during labor. Researchers will monitor fetal heart rate, uterine contractions, maternal blood pressure, and oxygen levels. Neonatal outcomes like weight and Apgar scores will also be recorded. The study will last up to 24 hours after delivery, with follow-up assessments focused on maternal and fetal circulation and pain control during labor.
CONDITIONS
Brief Title
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Term pregnant patients requesting labor analgesia
- Singleton pregnancy
- Term pregnant patients in active labor
- ASA less than 4
- No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE
- Patients with and without diagnosed hypertensive disorders of pregnancy
You will not qualify if you...
- Refusal to consent for the study
- Known spinal deformities
- Previous back instrumentation
- Patients with BMI greater than 50 kg/m² due to anticipated technical challenges in Doppler studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 minutes during active labor
Participants undergo ultrasound scans to measure velocimetric indices of the umbilical artery before and after combined spinal-epidural analgesia during labor.
1 to 2 visits depending on labor progression
Duration - Up to 24 hours post-delivery
Participants are observed for neonatal outcomes and delivery mode within 24 hours after delivery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
M
Mrinalini Balki, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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