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 action of oxytocin at
| Condition(s) | Post Partum Hemorrhage, Cesarean Section Complications, Blood Loss |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Lead sponsor | University of Chicago |
| Locations | Stanford, California, United States; Chicago, Illinois, United States |
| Start date | 2025-01-01 |
| NCT ID | NCT05488457 |
| Official listing | https://clinicaltrials.gov/study/NCT05488457 |