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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire
Secondary outcome measures
Heart rate
Calculated blood loss
Episodes of bleeding postpartum
+15 more

Trial Design

7Treatment 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 16 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 16 IU/h.
Group V: Oxytocin infusion rate 14 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 14 IU/h.
Group VI: Oxytocin infusion rate 12 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 12 IU/h.
Group VII: 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
127 Previous Clinical Trials
11,207 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,695 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
29 Previous Clinical Trials
1,949 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,225 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 10 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
2022. "Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05290129.
All > Pregnancy > Oxytocin
~8 spots leftby Dec 2024
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