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Hormone Therapy

Deuterated Oxytocin for Postpartum Hemorrhage

Phase 2
Waitlist Available
Led By Naida M Cole, MD
Research Sponsored by University of Chicago
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 intraoperatively (60 minutes following study drug administration)
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers understand why oxytocin, the first-line drug to prevent uterine atony, sometimes fails. Participants will receive a single dose of deuterium-labeled oxytocin, followed by an infusion of unlabeled oxytocin. Blood samples will be taken to measure plasma concentrations of both oxytocins over time.

Who is the study for?
This trial is for pregnant women aged 18-50, at term (37+ weeks), undergoing a scheduled or unscheduled but non-emergent cesarean delivery. It's not suitable for those with an emergency c-section or allergy to oxytocin, or who cannot consent.
What is being tested?
The study tests deuterated oxytocin (d5OT) to understand its pharmacokinetics and pharmacodynamics in preventing uterine atony after childbirth. Participants will receive d5OT intravenously post-delivery, followed by regular oxytocin, while their uterine contractions are monitored.
What are the potential side effects?
While the side effects aren't detailed here, typical reactions to oxytocin may include nausea, vomiting, and rapid heartbeat. The study aims to monitor how the uterus responds rather than focusing on adverse effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperatively (60 minutes following study drug administration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperatively (60 minutes following study drug administration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
0-10 Uterine Tone Score
Baseline plasma concentrations of deuterated oxytocin
Plasma concentrations of deuterated oxytocin at 1 minute
+8 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oxytocin PK/PD ArmExperimental Treatment1 Intervention
Eligible subjects will receive a single, 1 IU bolus of deuterated oxytocin (d5OT) intra-operatively, followed by an infusion of standard therapeutic d0 oxytocin immediately after placental delivery.

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,472 Previous Clinical Trials
17,501,718 Total Patients Enrolled
6 Trials studying Postpartum Hemorrhage
15,285 Patients Enrolled for Postpartum Hemorrhage
University of ChicagoLead Sponsor
1,055 Previous Clinical Trials
760,609 Total Patients Enrolled
1 Trials studying Postpartum Hemorrhage
100 Patients Enrolled for Postpartum Hemorrhage
Lucile Packard Children's HospitalOTHER
15 Previous Clinical Trials
2,671 Total Patients Enrolled

Media Library

Deuterated Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05488457 — Phase 2
Postpartum Hemorrhage Research Study Groups: Oxytocin PK/PD Arm
Postpartum Hemorrhage Clinical Trial 2023: Deuterated Oxytocin Highlights & Side Effects. Trial Name: NCT05488457 — Phase 2
Deuterated Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488457 — Phase 2
~67 spots leftby Sep 2025
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