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Procedure

Spinal-Epidural Analgesia for Labor Pain

N/A
Recruiting
Led By Mrinalini Balki, MD
Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ASA<4
Be between 18 and 65 years old
Must not have
Previous back instrumentation
Known spinal deformities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study the effects of combined spinal-epidural (CSE) for labor pain relief on maternal and fetal blood flow. CSE is known for providing quick pain relief during labor

Who is the study for?
This trial is for laboring women experiencing pain during childbirth. It's not specified who can't participate, but typically those with certain medical conditions or risks might be excluded.
What is being tested?
The study investigates how combined spinal-epidural analgesia affects blood flow in the uterine and umbilical arteries using Doppler ultrasound. The goal is to understand if this procedure impacts fetal heart rate by changing blood flow.
What are the potential side effects?
While not detailed here, common side effects of CSE may include a drop in maternal blood pressure, headache, backache, or temporary breathing difficulties for the baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My health is stable enough for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery on my back involving metal rods or screws.
Select...
I have a known spinal deformity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Umbilical artery velocimetric index - pulsatility index (PI) at 10 minutes
Umbilical artery velocimetric index - resistance index (RI) at 10 minutes
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes
Secondary study objectives
Apgar score at 1 minute
Apgar score at 5 minutes
Bradycardia: heart rate less than 70% of baseline
+31 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ultrasound - patients without hypertensive disorders of pregnancyExperimental Treatment1 Intervention
Ultrasound will be used to measure velocimetric index of the umbilical artery.
Group II: Ultrasound - patients with diagnosed hypertensive disorders of pregnancyExperimental Treatment1 Intervention
Ultrasound will be used to measure velocimetric index of the umbilical artery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~4090

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,557 Total Patients Enrolled
20 Trials studying Labor Pain
1,314 Patients Enrolled for Labor Pain
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
30 Previous Clinical Trials
2,077 Total Patients Enrolled
2 Trials studying Labor Pain
428 Patients Enrolled for Labor Pain
~36 spots leftby Jun 2025
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