Overview

Oxytocin PK/PD in Elective Cesarean Delivery

Status:
Not yet recruiting

Trial end date:
2024-06-30

Target enrollment:
0

Participant gender:
Female

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 (or 'what the body does to the drug') of a single intravenous (IV) dose of deuterium-labeled oxytocin (a novel tracing method to distinguish this dose from pre-existing oxytocin in the body and the standard variable dosing given in cesarean delivery). The second part will measure the pharmacodynamics (or 'what the drug does to the body') 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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Chicago

Treatments:

Oxytocin

Criteria

Inclusion Criteria

- 18-50 years old

- intrauterine pregnancy

- term pregnancy (>/= 37 weeks gestation)

- scheduled or unscheduled non-emergent cesarean delivery

Exclusion Criteria:

- emergent cesarean delivery

- allergy to oxytocin

- inability to provide informed consent