Actively Recruiting
Pharmacokinetics and Pharmacodynamics of Oxytocin in Cesarean Delivery
Led by University of Chicago · Updated on 2025-10-03
100
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how oxytocin works in women undergoing cesarean delivery to better understand why some experience uterine atony that does not respond to oxytocin. Oxytocin is commonly used to help the uterus contract after delivery and prevent excessive bleeding. This phase 2 study aims to measure both how the body processes oxytocin and how it affects uterine contraction strength in parturients. During the cesarean delivery, participants will receive a single intravenous bolus of deuterium-labeled oxytocin followed by an infusion of standard oxytocin after the placenta is delivered. Blood samples will be collected at multiple time points within one hour after delivery to measure oxytocin levels. Simultaneously, uterine tone scores from 0 to 10 will be recorded to evaluate uterine contraction strength and correlate with oxytocin concentrations. Participants will have an extra intravenous catheter placed to allow study blood draws during surgery. Researchers will analyze blood samples and uterine tone scores to understand the relationship between oxytocin levels and uterine contraction. The study's main outcomes include plasma oxytocin concentrations and uterine tone measured at multiple intervals up to 60 minutes after administration. The research will help identify factors behind oxytocin treatment failure and improve care during cesarean delivery.
CONDITIONS
Brief Title
Oxytocin Pharmacokinetics and Pharmacodynamics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 50 years old
- Intrauterine pregnancy
- Term pregnancy (greater than 39 weeks or 37-39 weeks with medical indication for delivery)
- Non-emergent (scheduled or unscheduled) cesarean delivery
You will not qualify if you...
- Allergy or contraindication to oxytocin
- Unable to provide informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 hour on the day of cesarean delivery
Participants receive a single 1 IU bolus of deuterated oxytocin (d5OT) intraoperatively during their cesarean delivery, followed by a standard oxytocin infusion after placental delivery. Blood samples and uterine tone scores are collected during the surgery to measure drug levels and effects.
1 intraoperative visit
Trial Site Locations
Total: 2 locations
1
Stanford University
Stanford, California, United States, 94305
Not Yet Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
N
Naida M Cole, MD
S
Somayeh Mohammadi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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