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

No Placebo-Only Group

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.

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.

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

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

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 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 III: 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 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.

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