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Phenylephrine + oxytocin for Postpartum Hemorrhage

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

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

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..

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,219 Total Patients Enrolled

30 Trials studying Postpartum Hemorrhage

1,701 Patients Enrolled for Postpartum Hemorrhage

Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

29 Previous Clinical Trials

1,961 Total Patients Enrolled

22 Trials studying Postpartum Hemorrhage

1,231 Patients Enrolled for Postpartum Hemorrhage

Frequently Asked Questions

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

Is the process of enrolling participants currently underway for this clinical trial?

"Per clinicaltrials.gov, recruitment for this trial is closed. The trial was initially listed on 2/1/2024 and most recently updated on 2/22/2024. Although this specific study is no longer enrolling participants, it's worth noting that there are currently 463 other active trials seeking candidates."

Answered by AI

Is there an opportunity for me to participate in this clinical study?

"To qualify for enrollment in this research, participants must present with postpartum hemorrhage and fall within the age bracket of 19 to 40 years. The study aims to recruit a total of 24 individuals."

Answered by AI

Is there an age restriction for participants in this medical trial, specifically excluding those under the age of 30?

"To be considered for participation in this research endeavor, individuals aged between 19 and 40 are sought. There are 52 trials dedicated to those under the age of 18 and a substantial number of 346 studies targeting participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

2024. "Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285396.

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