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 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperatively (60 minutes following study drug administration)

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.

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