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Etomidate for Postpartum Hemorrhage

N/A
Waitlist Available
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

Summary

Poor uterine tone after the birth of a baby may cause serious bleeding (called postpartum hemorrhage or PPH). This is a major cause of maternal death worldwide. In the developed world the cesarean section rate is increasing. There are two modalities for anesthesia for cesarean section; general and regional (eg. spinal anesthetic). General anesthesia has been associated with increased blood loss compared to regional and the reasons for this may be multifactorial. Some of the anesthesia gases have been studied and there is laboratory evidence to suggest that these gases may reduce the tone of the uterus and therefore cause increased blood loss due to poor uterine tone. To date there has been little study on the intravenous anesthesia agents. These agents are usually administered to anaesthetise the patient at the start of surgery (induction of anesthesia), however they can also be used instead of the gases to keep the patient asleep using a 'total intravenous anesthesia' technique. Laboratory work in rats has suggested that high doses of these intravenous drugs might reduce uterine tone, thus increasing the risk of blood loss. Interestingly, at low doses one of these drugs (ketamine) may actually increase uterine tone. Only one of these drugs has been studied in human uterine tissue. The investigators plan to compare three anaesthesia induction agents on human uterine tissue under physiological conditions in the laboratory. This study will be the first to compare these three drugs on human tissue. The investigators plan to determine the impact of these drugs on spontaneous uterine contractility and also contractilty induced by oxytocin, which is the drug most commonly administered to help contract the uterus after birth. This is important as it will help inform anesthesiologists as to the best drug to use depending on the clinical circumstance. The investigators hypothesize that the intravenous induction agents will cause a dose dependent decrease in spontaneous uterine contractility, similar to what has been described in the rat model. The investigators also expect that exposure to high concentrations of intravenous anesthesia induction agents will cause a blunted contractile response to oxytocin.

Eligible Conditions
  • Postpartum Hemorrhage

Timeline

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

Trial Design

6Treatment groups
Active Control
Group I: EtomidateActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of etomidate (from 10 -7M to 10 -4M)
Group II: Etomidate + oytocinActive Control2 Interventions
The myometrial samples are bathed in an oxytocin solution (20nM) with increasing concentrations of etomidate (from 10 -7M to 10 -4M)
Group III: Propofol + oytocinActive Control2 Interventions
The myometrial samples are bathed in an oxytocin solution (20nM) with increasing concentrations of propofol (from 10 -7M to 10 -4M)
Group IV: PropofolActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of propofol (from 10 -7M to 10 -4M)
Group V: KetamineActive Control1 Intervention
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ketamine (from 10 -7M to 10 -4M)
Group VI: Ketamine + oytocinActive Control2 Interventions
The myometrial samples are bathed in an oxytocin solution (20nM) with increasing concentrations of ketamine (from 10 -7M to 10 -4M)

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
128 Previous Clinical Trials
11,390 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,690 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
29 Previous Clinical Trials
1,950 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,220 Patients Enrolled for Postpartum Hemorrhage
~5 spots leftby Sep 2025