Oxytocin Pharmacokinetics and Pharmacodynamics

Part of paid clinical trials in Stanford, California.

Sponsor
University of Chicago
Study ID
NCT05488457
Phase
PHASE2
Status
Recruiting
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Conditions

  • Blood Loss
  • Cesarean Section Complications
  • Post Partum Hemorrhage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • deuterated oxytocin (d5OT) — DRUG
    Subjects will receive a 1 IU bolus of deuterated oxytocin (d5OT) intraoperatively during their nonemergent cesarean delivery.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Oxytocin PK/PD Arm
    Eligible subjects will receive a single, 1 IU bolus of deuterated oxytocin (d5OT) intra-operatively, followed by an infusion of standard therapeutic d0 oxytocin immediately after placental delivery.

Primary Outcome Measure

Baseline plasma concentrations of deuterated oxytocin [ Time Frame: Intraoperatively (prior to delivery) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Brendan Carvalho, MD
650-723-6415
University of ChicagoChicagoIllinois60637
Naida M Cole, MD
[email protected]
773-702-6700
Somayeh Mohammadi
[email protected]
17738343274

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