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Hormone Therapy

Oxytocin infusion rate 16 IU/h 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 24 hours
Awards & highlights

Summary

This study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. The aim of oxytocin is to reduce the amount of blood that might be lost. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. If the uterus contracts well, this is considered satisfactory and the next patient will receive the same dose. If the uterus does not contract well, this is considered unsatisfactory and the next patient will receive a higher dose. The dose for the next patient will be determined based on the results of the uterine contraction of the previous patient. The investigators hypothesize that the ED90 of an oxytocin infusion rate to maintain a satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower than that found in previous studies without an initial bolus (less than 16 IU/h).

Eligible Conditions
  • Postpartum Hemorrhage

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 upon discharge from the post anesthetic care unit (PACU): questionnaire
Secondary study objectives
Heart rate
Calculated blood loss
Episodes of bleeding postpartum
+17 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

Trial Design

8Treatment 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 2 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 2 IU/h.
Group V: Oxytocin infusion rate 16 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 16 IU/h.
Group VI: Oxytocin infusion rate 14 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 14 IU/h.
Group VII: Oxytocin infusion rate 12 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 12 IU/h.
Group VIII: 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
128 Previous Clinical Trials
11,383 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,683 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
29 Previous Clinical Trials
1,943 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,213 Patients Enrolled for Postpartum Hemorrhage
~10 spots leftby Sep 2025