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Oxytocin Pharmacokinetics and Pharmacodynamics
Pharmacokinetics and Pharmacodynamics of Oxytocin in Cesarean Delivery
Who can join
Ages 18 to 50 · Women
Full 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
About the study
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.
What is being tested
- deuterated oxytocin (d5OT) (drug)
Sponsor: Stanford University · Participants: 100 · Started: Jan 1, 2025
Contact the study team
- Naida M Cole, MD · Phone: 773-702-6700
- Somayeh Mohammadi · Phone: 17738343274
Official record on ClinicalTrials.gov — NCT05488457
Locations in the U.S.
| California | Stanford University, Stanford (Not yet recruiting) |
| Illinois | University of Chicago, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.