Investigating how oxytocin works during cesarean deliveries
Pharmacokinetics and Pharmacodynamics of Oxytocin in Cesarean Delivery
PHASE2 · University of Chicago · NCT05488457
This study is testing how oxytocin works during scheduled cesarean deliveries to see if it helps prevent complications like uterine atony in new mothers.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Chicago (other) |
| Locations | 2 sites (Stanford, California and 1 other locations) |
| Trial ID | NCT05488457 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to understand the pharmacokinetics and pharmacodynamics of oxytocin in parturients undergoing non-emergent cesarean deliveries. Participants will receive a bolus of deuterated oxytocin followed by a standard oxytocin infusion after the delivery of the fetus. Blood samples will be collected at various time points to analyze the concentration of oxytocin and its effect on uterine contraction. The study will help clarify how oxytocin functions in preventing uterine atony, a condition affecting many postpartum women.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-50 with a term intrauterine pregnancy undergoing a scheduled or unscheduled cesarean delivery.
Not a fit: Patients with allergies or contraindications to oxytocin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of postpartum hemorrhage by optimizing oxytocin use during cesarean deliveries.
How similar studies have performed: Other studies have explored oxytocin's role in postpartum care, but this specific pharmacokinetic and pharmacodynamic approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 18-50 years old * intrauterine pregnancy * term (\>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy * non-emergent (scheduled or unscheduled) cesarean delivery Exclusion Criteria: * allergy or contraindication to oxytocin * inability to provide informed consent
Where this trial is running
Stanford, California and 1 other locations
- Stanford University — Stanford, California, United States (NOT_YET_RECRUITING)
- University of Chicago — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Naida M Cole, MD — University of Chicago
- Study coordinator: Naida M Cole, MD
- Email: nmcole@bsd.uchicago.edu
- Phone: 773-702-6700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Partum Hemorrhage, Cesarean Section Complications, Blood Loss, Oxytocin, pharmacokinetics and Pharmacodynamics, Uterine Tone, Postpartum, Elective C-Section