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Ephedrine, Phenylephrine, and Norepinephrine for Gestational Diabetes

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 of 19-40 years
Patients with gestational age 37-41 weeks
Must not have
Patients who require general anesthesia
Maternal age >45
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how medication used to treat low blood pressure during a Cesarean delivery can affect the uterine muscle tissue and its ability to contract in patients with Type II and gestational

Who is the study for?
This trial is for pregnant individuals with Type II or gestational diabetes who are undergoing an elective Cesarean delivery. They must be willing to provide uterine tissue samples during the procedure. There's no specific exclusion criteria provided, but typically those with conditions that may interfere with study results or pose a risk would not qualify.
What is being tested?
The study investigates how different vasopressors—Ephedrine, Phenylephrine, and Norepinephrine—affect the contraction of uterine muscles when given after childbirth to manage low blood pressure caused by spinal anesthesia in diabetic patients.
What are the potential side effects?
While this study focuses on uterine contractility rather than side effects, vasopressors can generally cause increased heart rate, anxiety, headache, and possible changes in blood flow to the uterus which will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 am having a C-section with spinal anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need general anesthesia for my treatment.
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I am over 45 years old.
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I am willing to sign a consent form for the trial.
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I am currently in labor or receiving oxytocin to induce labor.
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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

8Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) only.
Group II: Phenylephrine + oxytocinActive Control2 Interventions
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine and oxytocin..
Group III: EphedrineActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine.
Group IV: PhenylephrineActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine.
Group V: NorepinephrineActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine.
Group VI: Control + oxytocinActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) and oxytocin.
Group VII: Ephedrine + oxytocinActive Control2 Interventions
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine and oxytocin..
Group VIII: Norepinephrine + oxytocinActive Control2 Interventions
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine and oxytocin..

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,515 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,721 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
30 Previous Clinical Trials
2,035 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,251 Patients Enrolled for Postpartum Hemorrhage
~0 spots leftby Dec 2024
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