RECRUITING

Oxytocin Pharmacokinetics and Pharmacodynamics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-01-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05488457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * allergy or contraindication to oxytocin
  2. * inability to provide informed consent

Contacts and Locations

Study Contact

Naida M Cole, MD
CONTACT
773-702-6700
nmcole@bsd.uchicago.edu
Somayeh Mohammadi
CONTACT
17738343274
mohammadis@bsd.uchicago.edu

Principal Investigator

Naida M Cole, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States
University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Naida M Cole, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Oxytocin
  • pharmacokinetics and Pharmacodynamics
  • Uterine Tone
  • Postpartum
  • Elective C-Section
  • Parturients

Additional Relevant MeSH Terms

  • Post Partum Hemorrhage
  • Cesarean Section Complications
  • Blood Loss