96 Participants NeededMy employer runs this trial

Ephedrine, Phenylephrine, and Norepinephrine for Gestational Diabetes

Mrinalini Balki, MD profile photo
Overseen ByMrinalini Balki, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Must be taking: Vasopressors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain medications, used to manage low blood pressure during C-sections, affect the uterine muscles' ability to contract in women with Type II and gestational diabetes. The focus is on three medications: ephedrine, phenylephrine, and norepinephrine, which commonly manage blood pressure. Researchers aim to determine how these drugs might impact the risk of postpartum hemorrhage (excessive bleeding after delivery), especially in diabetic patients. Women with Type II or gestational diabetes planning an elective C-section under spinal anesthesia might be suitable for this study.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how these medications affect diabetic patients during C-sections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past research has studied the safety of ephedrine, phenylephrine, and norepinephrine during pregnancy and childbirth.

For ephedrine, studies have shown no increased risk of major birth defects when used by pregnant women. It is considered safe for both mothers and babies during childbirth, especially compared to similar medications.

Phenylephrine is also considered safe for use during pregnancy. However, some concerns—though not proven—suggest it might reduce blood flow to the placenta, which provides nutrients to the baby.

Norepinephrine has been found to be as effective and safe as phenylephrine for managing low blood pressure in mothers during childbirth. No significant negative effects on mothers or babies have been reported.

Overall, these medications are generally well-tolerated and do not pose major risks during childbirth based on existing studies.12345

Why are researchers excited about this trial?

Unlike the standard treatments for gestational diabetes, which often involve insulin or oral medications to manage blood sugar levels, these investigational treatments—ephedrine, phenylephrine, and norepinephrine—work differently. Researchers are excited about these treatments because they target the blood flow and vascular dynamics, potentially improving uterine relaxation and fetal health without directly altering blood sugar. Additionally, when combined with oxytocin, these treatments may enhance uterine contractility in a more controlled manner, which could be beneficial during labor. This unique approach could offer an alternative for managing complications associated with gestational diabetes, focusing on the vascular system rather than just glucose control.

What evidence suggests that this trial's treatments could be effective for gestational diabetes?

This trial will evaluate the effects of ephedrine, phenylephrine, and norepinephrine on gestational diabetes. Research has shown that these medications effectively raise blood pressure during procedures like cesarean deliveries. Participants may receive ephedrine, which stabilizes the mother's blood pressure but can also increase heart rate. Others may receive phenylephrine, which effectively prevents low blood pressure during spinal anesthesia and usually affects heart rate less than ephedrine. Another group will receive norepinephrine, which also manages low blood pressure well; some studies suggest it works similarly to phenylephrine. All three medications increase blood pressure by acting on blood vessels, which is crucial during cesarean deliveries to prevent complications like heavy bleeding after birth.16789

Who Is on the Research Team?

MB

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients who have given consent to participate in the study
I am between 19 and 40 years old.
Patients requiring elective primary or first repeat caesarean delivery
See 6 more

Exclusion Criteria

I need general anesthesia for my treatment.
I am over 45 years old.
Emergency caesarean delivery in labor
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Uterine tissue samples are collected from the incision site following cesarean delivery for laboratory experiments

Immediate post-delivery
1 visit (in-person)

In-vitro Experimentation

Myometrial samples are bathed in physiological salt solution with varying concentrations of vasopressors and oxytocin to study contractility

4 hours

Follow-up

Participants are monitored for safety and effectiveness after sample collection and experimentation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ephedrine
  • Norepinephrine
  • Phenylephrine

Trial Overview

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.

How Is the Trial Designed?

8

Treatment groups

Active Control

Group I: ControlActive Control1 Intervention
Group II: Phenylephrine + oxytocinActive Control2 Interventions
Group III: EphedrineActive Control1 Intervention
Group IV: PhenylephrineActive Control1 Intervention
Group V: NorepinephrineActive Control1 Intervention
Group VI: Control + oxytocinActive Control1 Intervention
Group VII: Ephedrine + oxytocinActive Control2 Interventions
Group VIII: Norepinephrine + oxytocinActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials
132
Recruited
11,400+

Citations

Pharmacometric Analysis of Cafedrine/Theodrenaline ...

Maximum HR (MAXHR) was 15% higher after ephedrine than after C/T (p < 0.001). BMI and spinal block height significantly influenced maternal hemodynamics (both p ...

Dissecting Vasopressor Efficacy in the Management of...

Interventions were intermittent bolus phenylephrine, norepinephrine, or ephedrine, with outcomes on maternal hemodynamics, neonatal status, and adverse events.

Pharmacometric Analysis of Cafedrine/Theodrenaline ...

Maximum HR (MAXHR) was 15% higher after ephedrine than after C/T (p < 0.001). BMI and spinal block height significantly influenced maternal ...

Review Phenylephrine vs ephedrine in cesarean delivery ...

We conducted a meta-analysis to compare phenylephrine versus ephedrine in cesarean delivery under spinal anesthesia. •. Phenylephrine and ephedrine were both ...

Perinatal Outcomes After the Use of Kampo Medicines ... - PMC

No statistically significant association was seen between the use of Kampo medicines containing ephedra during pregnancy and an increased risk ...

Ephedrine Use During Pregnancy

Risk summary: Available data from studies and reports on the use of this drug in pregnant women have not identified a drug-associated risk of major birth ...

Randomized Trial of Bolus Ephedrine or Mephentermine for...

... ephedrine has a better safety profile than mephentermine. However, our study showed that both drugs were equally safe in terms of fetal outcome. With regard ...

208289Orig1s000

Overall, clinical trials in the publications submitted to support the efficacy of Akovaz demonstrated ephedrine's ability to increase blood ...

Dissecting Vasopressor Efficacy in the Management of ...

To evaluate the safety and effectiveness of intermittent bolus administration of ephedrine, norepinephrine, and phenylephrine in the treatment ...