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Spinal-Epidural Analgesia for Labor Pain

Q: What are the aims of this clinical research?

This experiment is designed to measure the Umbilical artery velocimetric index-resistance index (PI) at 10 minutes as its primary outcome within a 5 minute window. Secondary outcomes include <a href="https://www.withpower.com/clinical-trials/pain">Pain</a> score, Hypotension level, and Fetal heart rate which are <a href="https://www.withpower.com/clinical-trials/all">all</a> recorded every 5 minutes up until 30 minutes post combined spinal epidural injection.

Q: How many participants are accepted for this clinical investigation?

Affirmative. Clinicaltrials.gov details that as of October 24th 2022, this trial is still recruiting participants from a single location to make up the total of 24 enrollees. The study was first posted on September 14th 2022.

Q: Does this clinical trial accept anyone over the age of sixty as a participant?

The conditions of participant inclusion necessitate that prospective participants must lie between 18 and 50 years old.

Q: Are there any remaining vacancies for participants in this trial?

Per the information listed on clinicaltrials.gov, this medical study is enlisting participants with its most recent edits made on October 24th 2022 since first being posted in September 14th 2022.

Q: May I partake in this experiment?

This trial is enrolling 24 participants in the 18-50 age range that are currently enduring labor pains and meet the following qualifications: Written informed consent, Term pregnant patients requesting labor analgesia, Singleton <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a>, Patients with no evidence of fetal anomalies or decelerations prior to CSE and an ASA&#x3C;4.

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 minute2

Awards & highlights

Study Summary

This trial looks at the combined spinal-epidural (CSE) technique for labor pain relief. It aims to investigate how it affects maternal and fetal blood flow and its relationship to fetal bradycardia (slowed heart rate).

Who is the study for?

This trial is for term pregnant women in active labor who want pain relief and have no prior fetal complications or spinal issues. They must consent to the study, have a single pregnancy without congenital anomalies, be relatively healthy (ASA<4), and not severely overweight (BMI under 50 kg/m2).Check my eligibility

What is being tested?

The study tests how combined spinal-epidural analgesia affects blood flow in maternal uterine and fetal umbilical arteries during labor. It uses Doppler ultrasound to monitor changes before and after CSE administration, aiming to understand its link with fetal bradycardia.See study design

What are the potential side effects?

While CSE is generally beneficial for pain relief during labor, there's a small chance it can cause abnormal fetal heart rates that usually resolve on their own with little or no intervention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 minute2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 minute2

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minute2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Umbilical artery velocimetric index - pulsatility index (PI) at 10 minutes

Umbilical artery velocimetric index - pulsatility index (PI) at 30 minutes

Umbilical artery velocimetric index - pulsatility index (PI) at baseline

+15 more

Secondary outcome measures

Apgar score at 1 minute

Apgar score at 5 minutes

Bradycardia: heart rate less than 70% of baseline

+16 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: UltrasoundExperimental Treatment1 Intervention

Ultrasound will be used to measure velocimetric indices of both right and left uterine arteries and umbilical artery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound

2013

Completed Phase 1

~1950

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,213 Total Patients Enrolled

18 Trials studying Labor Pain

1,102 Patients Enrolled for Labor Pain

Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

29 Previous Clinical Trials

1,955 Total Patients Enrolled

1 Trials studying Labor Pain

398 Patients Enrolled for Labor Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the aims of this clinical research?

"This experiment is designed to measure the Umbilical artery velocimetric index-resistance index (PI) at 10 minutes as its primary outcome within a 5 minute window. Secondary outcomes include Pain score, Hypotension level, and Fetal heart rate which are all recorded every 5 minutes up until 30 minutes post combined spinal epidural injection."

Answered by AI

How many participants are accepted for this clinical investigation?

"Affirmative. Clinicaltrials.gov details that as of October 24th 2022, this trial is still recruiting participants from a single location to make up the total of 24 enrollees. The study was first posted on September 14th 2022."

Answered by AI

Does this clinical trial accept anyone over the age of sixty as a participant?

"The conditions of participant inclusion necessitate that prospective participants must lie between 18 and 50 years old."

Answered by AI

Are there any remaining vacancies for participants in this trial?

"Per the information listed on clinicaltrials.gov, this medical study is enlisting participants with its most recent edits made on October 24th 2022 since first being posted in September 14th 2022."

Answered by AI

May I partake in this experiment?

"This trial is enrolling 24 participants in the 18-50 age range that are currently enduring labor pains and meet the following qualifications: Written informed consent, Term pregnant patients requesting labor analgesia, Singleton pregnancy, Patients with no evidence of fetal anomalies or decelerations prior to CSE and an ASA<4."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05512065.

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