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Hormone Therapy

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 24 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to find the least amount of oxytocin needed to keep the uterus contracted during cesarean delivery, to help reduce blood loss.

Who is the study for?
This trial is for women in labor who are having a cesarean delivery under neuraxial anesthesia and have been exposed to oxytocin for at least 3 hours. It's not suitable for those with hypertension, severe heart issues, allergies to oxytocin, contraindications to neuraxial anesthesia, or if general anesthesia becomes necessary during surgery.
What is being tested?
The study aims to find the lowest effective dose of oxytocin infusion needed after an initial bolus dose during cesarean delivery. The dosage will be adjusted up or down based on the previous patient's uterine response, aiming for better control of blood loss post-delivery.
What are the potential side effects?
Oxytocin can cause side effects such as nausea, vomiting, and headaches. In some cases, it might lead to increased bleeding or changes in blood pressure and heart rate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire
Secondary study objectives
Heart rate
Calculated blood loss
Episodes of bleeding postpartum
+15 more

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

Awards & Highlights

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

Trial Design

17Treatment groups
Experimental Treatment
Group I: Oxytocin infusion rate 8 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 8 IU/h.
Group II: Oxytocin infusion rate 6 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 6 IU/h.
Group III: Oxytocin infusion rate 4 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 4 IU/h.
Group IV: Oxytocin infusion rate 36 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 36 IU/h.
Group V: Oxytocin infusion rate 34 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 34 IU/h.
Group VI: Oxytocin infusion rate 32 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 32 IU/h.
Group VII: Oxytocin infusion rate 30 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 30 IU/h.
Group VIII: Oxytocin infusion rate 28 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 28 IU/h.
Group IX: Oxytocin infusion rate 26 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 26 IU/h.
Group X: Oxytocin infusion rate 24 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 24 IU/h.
Group XI: Oxytocin infusion rate 22 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 22 IU/h.
Group XII: Oxytocin infusion rate 20 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 20 IU/h.
Group XIII: Oxytocin infusion rate 18 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 18 IU/h.
Group XIV: Oxytocin infusion rate 16 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 16 IU/h.
Group XV: Oxytocin infusion rate 14 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 14 IU/h.
Group XVI: Oxytocin infusion rate 12 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 12 IU/h.
Group XVII: Oxytocin infusion rate 10 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 10 IU/h.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,571 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,777 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
30 Previous Clinical Trials
2,091 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,307 Patients Enrolled for Postpartum Hemorrhage

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05290129 — N/A
Postpartum Hemorrhage Research Study Groups: Oxytocin infusion rate 16 IU/h, Oxytocin infusion rate 14 IU/h, Oxytocin infusion rate 12 IU/h, Oxytocin infusion rate 22 IU/h, Oxytocin infusion rate 28 IU/h, Oxytocin infusion rate 10 IU/h, Oxytocin infusion rate 26 IU/h, Oxytocin infusion rate 30 IU/h, Oxytocin infusion rate 36 IU/h, Oxytocin infusion rate 34 IU/h, Oxytocin infusion rate 18 IU/h, Oxytocin infusion rate 24 IU/h, Oxytocin infusion rate 20 IU/h, Oxytocin infusion rate 32 IU/h, Oxytocin infusion rate 4 IU/h, Oxytocin infusion rate 6 IU/h, Oxytocin infusion rate 8 IU/h
Postpartum Hemorrhage Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT05290129 — N/A
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05290129 — N/A
~8 spots leftby Jul 2025
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