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Oxytocic

Oxytocin + Dexmedetomidine 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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

Study Summary

This trial is testing whether the drug dexmedetomidine affects myometrial contractility in pregnant women.

Who is the study for?

This trial is for pregnant women between 37-41 weeks of gestation who are scheduled for their first or second elective cesarean delivery under regional anesthesia. Women with conditions that could affect uterine muscle contractions, those needing emergency C-sections, general anesthesia, or refusing to participate are not eligible.Check my eligibility

What is being tested?

The study is examining how dexmedetomidine affects the contraction of the uterus during childbirth when used alongside oxytocin. Researchers believe dexmedetomidine may increase these contractions in a dose-dependent manner and want to test this on human myometrium tissue.See study design

What are the potential side effects?

While specific side effects related to the uterus aren't detailed here, generally dexmedetomidine can cause low blood pressure, slow heart rate, dry mouth, and nausea. Oxytocin can lead to intense contractions which might result in discomfort.

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

6Treatment groups

Active Control

Group I: Dexmedetomidine + OxytocinActive Control2 Interventions

The myometrial samples are bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M).

Group II: Oxytocin pre-treatment followed by OxytocinActive Control1 Intervention

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM.

Group III: Oxytocin pre-treatment followed by DexmedetomidineActive Control2 Interventions

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).

Group IV: Oxytocin pre-treatment followed by Dexmedetomidine + OxytocinActive Control2 Interventions

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M)

Group V: DexmedetomidineActive Control1 Intervention

The myometrial samples are bathed in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).

Group VI: OxytocinActive Control1 Intervention

The myometrial samples are bathed in oxytocin 20nM.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,209 Total Patients Enrolled

30 Trials studying Postpartum Hemorrhage

1,697 Patients Enrolled for Postpartum Hemorrhage

Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

29 Previous Clinical Trials

1,951 Total Patients Enrolled

22 Trials studying Postpartum Hemorrhage

1,227 Patients Enrolled for Postpartum Hemorrhage

Media Library

Oxytocin (Oxytocic) Clinical Trial Eligibility Overview. Trial Name: NCT05511415 — N/A

Postpartum Hemorrhage Research Study Groups: Dexmedetomidine + Oxytocin, Oxytocin pre-treatment followed by Oxytocin, Oxytocin pre-treatment followed by Dexmedetomidine, Oxytocin pre-treatment followed by Dexmedetomidine + Oxytocin, Dexmedetomidine, Oxytocin

Postpartum Hemorrhage Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT05511415 — N/A

Oxytocin (Oxytocic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05511415 — N/A

Frequently Asked Questions

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

Does my profile fit the criteria for this research project?

"This study seeks 28 participants aged 18 to 50 who have recently experienced postpartum hemorrhaging. Notably, prospective patients should be pregnant and scheduled for elective cesarean delivery under regional anesthesia between 37-41 weeks of gestational age; those having undergone multiple CD will not qualify for the trial due to potential uterine scarring."

Answered by AI

Does this research accommodate the participation of elderly individuals?

"To be considered for entry, patient must meet the age criteria of 18 - 50 years old."

Answered by AI

How many participants are currently enrolled in this trial?

"Correct. The clinicaltrials.gov database indicates that this trial, first published on November 2nd 2022, is presently searching for subjects to enroll. A total of 28 participants need to be recruited from a single location."

Answered by AI

Are there any vacancies for participants in this experiment?

"Affirmative. According to the data on clinicaltrials.gov, this trial has been recruiting since November 2nd 2022 and was last updated on November 10th of that year. The research is attempting to admit 28 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine

2022. "In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05511415.

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