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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Motility index
Secondary outcome measures
Amplitude of contraction
Frequency of contraction
Integrated area under response curve (AUC)

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
~2050

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
127 Previous Clinical Trials
11,093 Total Patients Enrolled
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
29 Previous Clinical Trials
1,835 Total Patients Enrolled

Media Library

Ephedrine (Sympathomimetic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04053478 — N/A
Low Blood Pressure Research Study Groups: Myometrium + Ephedrine, Myometrium + Vasopressin, Umbilical vein + Vasopressin, Umbilical vein + Norepinephrine, Umbilical artery + Vasopressin, Umbilical vein + Ephedrine, 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

Frequently Asked Questions

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

What qualifications are necessary for a person to be accepted into this medical experiment?

"This clinical trial is open to individuals between the ages of 19 and 40 who suffer from hypotension; up to 144 participants are eligible for inclusion."

Answered by AI

Is recruitment for this trial still ongoing?

"According to the data hosted on clinicaltrials.gov, enrollment for this study is currently in progress. It was first made public on July 8th 2019 and has since been updated as recently as October 24th 2022."

Answered by AI

How many participants are receiving treatment through this clinical examination?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this scientific endeavour, which was initially posted on July 8th 2019, is actively seeking participants. Approximately 144 individuals need to be enrolled from a single medical centre."

Answered by AI

Are elderly patients able to participate in this trial?

"As stated in the guidelines for this investigation, participants must be between 19 and 40 years old."

Answered by AI

What medical conditions is Ephedrine generally employed to treat?

"Ephedrine is often an effective remedy for dilated pupils, catarrh, and rhinorrhoea."

Answered by AI

What precedent has been established by previous experiments involving Ephedrine?

"At present, researchers are conducting 39 clinical trials on the efficacy of ephedrine. Among those studies, 8 have made it to Phase 3 status and are based primarily in Salt Lake City; however there are 66 total trial locations for this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study
2019. "Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04053478.
~16 spots leftby Dec 2024
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