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Oxytocin

Carbetocin vs Oxytocin 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 90 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare two medications, oxytocin and carbetocin, commonly used to prevent excessive uterine bleeding after cesarean delivery. Most previous studies focused on low-risk patients

Who is the study for?
This trial is for women at high risk of heavy bleeding after a cesarean delivery. Risk factors include having twins or more, a large baby, too much amniotic fluid, previous heavy bleeding after birth, obesity (BMI over 40), diabetes, high blood pressure, and placenta previa.
What is being tested?
The study compares two drugs used to prevent excessive bleeding post-cesarean: oxytocin and carbetocin. It specifically looks at their effectiveness in women with higher chances of postpartum hemorrhage due to certain health conditions.
What are the potential side effects?
Possible side effects from both oxytocin and carbetocin may include nausea, vomiting, abdominal pain, headache, feeling flushed or warm. These medications can also cause changes in heart rate or blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of parturients requiring additional uterotonic agents intraoperatively
Secondary study objectives
Additional uterotonics administered up to 24 hours post delivery: questionnaire
Calculated blood loss (CBL)
Number of patients with ICU admission
+21 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Oxytocin 5IUActive Control1 Intervention
IV oxytocin 5 IU diluted in 10 mL normal saline over 1 min followed by continuous infusion of 250 mIU/min over 4 hours.
Group II: Carbetocin 100mcgActive Control1 Intervention
IV carbetocin 100 mcg diluted in 10 mL normal saline over 1 min followed by placebo infusion for 4 hours after the delivery of the fetus.

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,451 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,657 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
30 Previous Clinical Trials
1,971 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,187 Patients Enrolled for Postpartum Hemorrhage
~107 spots leftby Jul 2025
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