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Uterotonics 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
Patients with gestational age 37-41 weeks
Non-laboring patients, not exposed to exogenous oxytocin
Must not have
Patient refusal
Patients who require general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Summary
This trial aims to study different drugs that help the uterus contract after childbirth to prevent excessive bleeding. The researchers will test which drug works best to reduce the risk of bleeding after carbetocin has been
Who is the study for?
This trial is for individuals who have recently given birth and are experiencing postpartum hemorrhage, a condition where the uterus does not contract strongly enough to stop bleeding. The study focuses on those who do not respond adequately to initial treatment with carbetocin.
What is being tested?
The study tests the effectiveness of additional uterotonic drugs (ergonovine, carboprost, oxytocin) after carbetocin has been used. It aims to determine which drug best reduces the risk of continued bleeding in an ex-vivo setting using uterine tissue samples.
What are the potential side effects?
As this is an ex-vivo study involving uterine tissue samples rather than direct patient treatment, participants will not experience side effects from the drugs being tested within this specific trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am pregnant and between 37 to 41 weeks along.
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I have not been given oxytocin for labor induction.
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I am having a cesarean delivery under spinal anesthesia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chosen not to participate in this trial.
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I need general anesthesia for my treatment.
Select...
I have had surgery on my uterus or more than one C-section.
Select...
I am currently in labor or receiving oxytocin to induce labor.
Select...
I have a high BMI (>40) which increases my risk for weak uterine muscles and heavy bleeding after birth.
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
Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: CarbetocinActive Control2 Interventions
Dose-response testing with increasing concentrations of carbetocin in a pattern of 1 log molar increase every 10 min, from 10-5 M to 10-5 M
Group II: OxytocinActive Control2 Interventions
Dose-response testing with increasing concentrations of oxytocin from 10-10 M to 10-5 M.
Group III: ErgometrineActive Control3 Interventions
Dose-response testing with increasing concentrations of ergometrine from 10-10 M to 10-5 M
Group IV: CarboprostActive Control3 Interventions
Dose-response testing with increasing concentrations of carboprost from 10-10 M to 10-5 M
Group V: ControlPlacebo Group2 Interventions
No drug added to physiological salt solution (PSS).
Find a Location
Who is running the clinical trial?
Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,579 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,785 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
30 Previous Clinical Trials
2,099 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,315 Patients Enrolled for Postpartum Hemorrhage