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Sympathomimetic Agent

Vasopressors for Low Blood Pressure

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
Patients undergoing caesarean delivery under spinal anesthesia
Patients of 19-40 years
Must not have
Patients on medications that could affect myometrial contractility, such as insulin, nifedipine, labetolol or magnesium sulfate
Patients who require general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the effects of ephedrine, phenylephrine, and norepinephrine on the contractility of pregnant myometrium and umbilical arteries.

Who is the study for?
This trial is for non-laboring patients aged 19-40, undergoing elective primary or first repeat cesarean delivery under spinal anesthesia at a gestational age of 37-41 weeks. They must consent to participate and not have had previous uterine surgery beyond one cesarean, nor be on medications affecting myometrial contractility.
What is being tested?
The study tests the effects of vasopressors—Ephedrine, Phenylephrine, Norepinephrine, and Vasopressin—on the muscle contractions of the uterus (myometrium) and umbilical vessels in vitro. It aims to understand how these drugs can manage low blood pressure during cesarean deliveries without harming mother or baby.
What are the potential side effects?
Potential side effects may include changes in heart rate or blood pressure for mothers. Since it's an in-vitro study (outside a living body), direct side effects are not applicable to participants but will inform potential risks in clinical use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a C-section with spinal anesthesia.
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I am between 19 and 40 years old.
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I am pregnant and between 37 to 41 weeks along.
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I have not been given oxytocin for labor induction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication that could affect muscle contractions in my uterus.
Select...
I need general anesthesia for my treatment.
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I refuse to sign the consent form for the trial.
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I had an emergency C-section while in labor.
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I am currently in labor or receiving oxytocin to start labor.
Select...
I have had surgery on my uterus or more than one C-section.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Motility index
Secondary study objectives
Amplitude of contraction
Frequency of contraction

Awards & Highlights

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

Trial Design

12Treatment groups
Experimental Treatment
Group I: Umbilical vein + VasopressinExperimental Treatment1 Intervention
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of vasopressin
Group II: Umbilical vein + PhenylephrineExperimental Treatment1 Intervention
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine
Group III: Umbilical vein + NorepinephrineExperimental Treatment1 Intervention
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine
Group IV: Umbilical vein + EphedrineExperimental Treatment1 Intervention
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine
Group V: Umbilical artery + VasopressinExperimental Treatment1 Intervention
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of vasopressin
Group VI: Umbilical artery + PhenylephrineExperimental Treatment1 Intervention
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine
Group VII: Umbilical artery + NorepinephrineExperimental Treatment1 Intervention
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine
Group VIII: Umbilical artery + EphedrineExperimental Treatment1 Intervention
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine
Group IX: Myometrium + VasopressinExperimental Treatment1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of vasopressin
Group X: Myometrium + PhenylephrineExperimental Treatment1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine
Group XI: Myometrium + NorepinephrineExperimental Treatment1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine
Group XII: Myometrium + EphedrineExperimental Treatment1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vasopressin
2014
Completed Phase 4
~24780
Ephedrine
2016
Completed Phase 4
~26810
Norepinephrine
2014
Completed Phase 4
~1780
Phenylephrine
2014
Completed Phase 4
~2040

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,467 Total Patients Enrolled
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
30 Previous Clinical Trials
1,987 Total Patients Enrolled

Media Library

Ephedrine (Sympathomimetic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04053478 — N/A
Low Blood Pressure Research Study Groups: Myometrium + Vasopressin, Umbilical artery + Vasopressin, Umbilical vein + Ephedrine, Myometrium + Ephedrine, Umbilical vein + Vasopressin, Umbilical vein + Norepinephrine, Umbilical vein + Phenylephrine, Myometrium + Norepinephrine, Umbilical artery + Ephedrine, Umbilical artery + Norepinephrine, Umbilical artery + Phenylephrine, Myometrium + Phenylephrine
Low Blood Pressure Clinical Trial 2023: Ephedrine Highlights & Side Effects. Trial Name: NCT04053478 — N/A
Ephedrine (Sympathomimetic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04053478 — N/A
~0 spots leftby Dec 2024
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