NCT05488457 Oxytocin Pharmacokinetics and Pharmacodynamics
| NCT ID | NCT05488457 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Post Partum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria * 18-50 years old * intrauterine pregnancy * term (\>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy * non-emergent (scheduled or unscheduled) cesarean delivery Exclusion Criteria: * allergy or contraindication to oxytocin * inability to provide informed consent
Contact & Investigator
Naida M Cole, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT05488457 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Post Partum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05488457 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05488457 currently recruiting?
Yes, NCT05488457 is actively recruiting participants. Contact the research team at nmcole@bsd.uchicago.edu for enrollment information.
Where is the NCT05488457 trial being conducted?
This trial is being conducted at Stanford, United States, Chicago, United States.
Who is sponsoring the NCT05488457 clinical trial?
NCT05488457 is sponsored by Stanford University. The principal investigator is Naida M Cole, MD at University of Chicago. The trial plans to enroll 100 participants.