Oxytocin pre-treatment followed by Oxytocin for Postpartum Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mount Sinai Hospital, Toronto, Canada
Postpartum Hemorrhage+1 More
Dexmedetomidine - Drug
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality. It has been noted that an increasing number of PPH is attributed to the increased incidence of uterine atony. Myometrial contraction is affected by the choice of anesthetic technique and medications during cesarean delivery (CD). It has been proven that exposure to oxytocin during labor results in a decrease in myometrial contractions. Dexmedetomidine is a drug which has been used in obstetric practice due to its desirable effects such as decreasing pain, reduced elevation in blood pressure and heart rate, sedation, and diminished anesthetic requirement. It has been used as an adjunct during spinal or epidural anesthesia during CD and even during general anesthesia for some obstetric surgeries. The use of dexmedetomidine has been continuously rising due to its favorable effects. Its use as an adjunct in general anesthesia for obstetrical surgeries has been shown to have promising advantages. During this pandemic, dexmedetomidine has been utilized largely as a sedative in critically ill and intubated patients. This does not exclude critically ill pregnant patients who may also need to deliver urgently. Thus, it is important to investigate its effect on uterine contractility on this particular group of patients. The investigators hypothesize that dexmedetomidine causes a dose-dependent increase in contractility of the pregnant human myometrium, both spontaneous and oxytocin-induced.

Eligible Conditions

  • Postpartum Hemorrhage

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Postpartum Hemorrhage

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 4 hours

4 hours
Amplitude of contraction
Frequency of contraction
Integrated area under response curve (AUC)
Motility index

Trial Safety

Safety Progress

1 of 3

Other trials for Postpartum Hemorrhage

Trial Design

6 Treatment Groups

Oxytocin pre-treatment followed by Oxytocin
1 of 6
Dexmedetomidine + Oxytocin
1 of 6
Oxytocin pre-treatment followed by Dexmedetomidine + Oxytocin
1 of 6
Dexmedetomidine
1 of 6
Oxytocin pre-treatment followed by Dexmedetomidine
1 of 6
Oxytocin
1 of 6
Active Control

28 Total Participants · 6 Treatment Groups

Primary Treatment: Oxytocin pre-treatment followed by Oxytocin · No Placebo Group · N/A

Oxytocin pre-treatment followed by Oxytocin
Drug
ActiveComparator Group · 1 Intervention: Oxytocin · Intervention Types: Drug
Dexmedetomidine + OxytocinActiveComparator Group · 2 Interventions: Dexmedetomidine, Oxytocin · Intervention Types: Drug, Drug
Oxytocin pre-treatment followed by Dexmedetomidine + OxytocinActiveComparator Group · 2 Interventions: Dexmedetomidine, Oxytocin · Intervention Types: Drug, Drug
Dexmedetomidine
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Oxytocin pre-treatment followed by DexmedetomidineActiveComparator Group · 2 Interventions: Dexmedetomidine, Oxytocin · Intervention Types: Drug, Drug
Oxytocin
Drug
ActiveComparator Group · 1 Intervention: Oxytocin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 hours
Closest Location: Mount Sinai Hospital · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2011First Recorded Clinical Trial
29 TrialsResearching Postpartum Hemorrhage
494 CompletedClinical Trials

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
115 Previous Clinical Trials
10,264 Total Patients Enrolled
27 Trials studying Postpartum Hemorrhage
1,461 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
26 Previous Clinical Trials
1,603 Total Patients Enrolled
19 Trials studying Postpartum Hemorrhage
991 Patients Enrolled for Postpartum Hemorrhage

Eligibility Criteria

Age 18 - 65 · Female Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients who are pregnant or are planning to become pregnant will be included in this study.
Patients who are not pregnant or who have a history of uterine fibroids are eligible for this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.