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NCT05488457 · ClinicalTrials.gov registry record · Phase 2
Oxytocin Pharmacokinetics and Pharmacodynamics
A Phase 2 study of Cesarean Section Complications and Blood Loss, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT05488457 is a Phase 2 study of Cesarean Section Complications and Blood Loss that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 100 participants, below the 762-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05488457, a Phase 2 study of Cesarean Section Complications and Blood Loss, 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05488457
The ClinicalTrials.gov registry entry for NCT05488457 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 762-participant average among 9 other Cesarean Section Complications trials with a reported enrollment target (87% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cesarean Section Complications appearing as the primary indexed condition, and to 1 intervention - of which deuterated oxytocin (d5OT) is the first listed.
NCT05488457 reports 2 study locations spanning 2 distinct geographic areas - top geographies include 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: Cesarean Section Complications, Blood Loss, Post Partum Hemorrhage.
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.
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