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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
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
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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Who is running the clinical trial?
Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,561 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,767 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
30 Previous Clinical Trials
2,081 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,297 Patients Enrolled for Postpartum Hemorrhage
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant, planning a C-section at 37-41 weeks, and will have regional anesthesia.I have chosen not to participate in certain treatments or procedures.I am on medication that affects muscle contractions in my uterus.I will be put to sleep for surgery.I am undergoing my first or second surgery for Crohn's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Dexmedetomidine + Oxytocin
- Group 2: Oxytocin pre-treatment followed by Dexmedetomidine
- Group 3: Oxytocin pre-treatment followed by Oxytocin
- Group 4: Oxytocin pre-treatment followed by Dexmedetomidine + Oxytocin
- Group 5: Dexmedetomidine
- Group 6: Oxytocin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.