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Oxytocin

Oxytocin 5IU 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 90 minutes

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 minutes

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of parturients requiring additional uterotonic agents intraoperatively

Secondary outcome measures

Calculated blood loss (CBL)

Number of patients with ICU admission

Number of patients with bradycardia defined as heart rate less than 70% of baseline

+20 more

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,077 Total Patients Enrolled

30 Trials studying Postpartum Hemorrhage

1,565 Patients Enrolled for Postpartum Hemorrhage

Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

29 Previous Clinical Trials

1,819 Total Patients Enrolled

22 Trials studying Postpartum Hemorrhage

1,095 Patients Enrolled for Postpartum Hemorrhage

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities for individuals to participate in this ongoing medical study?

"The information available on clinicaltrials.gov indicates that the recruitment phase for this particular trial has concluded. The trial was first listed on March 1, 2024, with its latest update noted on March 22, 2024. While this study is no longer enrolling participants, it's noteworthy that there are currently 370 other trials actively seeking eligible candidates."

Answered by AI

Do I meet the criteria to participate in this research project?

"Individuals aged between 18 and 50 suffering from postpartum hemorrhage are eligible to participate in this research trial, which aims to enroll approximately 160 subjects."

Answered by AI