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NCT05488457 · ClinicalTrials.gov registry record · Phase 2
Oxytocin Pharmacokinetics and Pharmacodynamics
A Phase 2 study of Postpartum Hemorrhage and Cesarean Section Complications, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT05488457: Recruiting Phase 2 study of Postpartum Hemorrhage and Cesarean Section Complications, sponsored by University of Chicago.
NCT05488457 is a Phase 2 study of Postpartum Hemorrhage and Cesarean Section Complications that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 100 participants, below the 775-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05488457, a Phase 2 study of Postpartum Hemorrhage and Cesarean Section Complications, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus. After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship. The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.
Primary Outcome
The plasma concentration of deuterium labelled oxytocin at baseline
Conditions Studied
Interventions
- DRUG deuterated oxytocin (d5OT)
Study Locations (2)
California
- Stanford University - Stanford
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT05488457 shows while recruiting
NCT05488457 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 775-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Postpartum Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which deuterated oxytocin (d5OT) is the first listed.
NCT05488457 reports a single indexed study location in California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05488457 about?
NCT05488457 is a clinical study titled "Oxytocin Pharmacokinetics and Pharmacodynamics". Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the a...
What is the current status of trial NCT05488457?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-01-01. Estimated completion is 2027-12-31.
What conditions does trial NCT05488457 study?
This clinical trial studies the following conditions: Postpartum Hemorrhage, Cesarean Section Complications, Blood Loss.
What interventions are being tested in trial NCT05488457?
The interventions under investigation include: deuterated oxytocin (d5OT) (DRUG).
Who is sponsoring clinical trial NCT05488457?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05488457 being conducted?
This trial has 2 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05488457's enrollment target sits among peer trials
100 12th of 19 higher than 8 of 19 other Postpartum Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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