Oxytocin Pharmacokinetics and Pharmacodynamics

Trial ID or NCT#

NCT05488457

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Pharmacokinetics and Pharmacodynamics of Oxytocin in Cesarean Delivery

Eligibility Criteria

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Exclusion Criteria:
  1. * allergy or contraindication to oxytocin* inability to provide informed consent

Investigator(s)

Brendan Carvalho
Brendan Carvalho
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics) and, by courtesy, of Obstetrics and Gynecology (Maternal Fetal Medicine)