Oxytocin for Complications After Cesarean Delivery
Oxytocin Pharmacokinetics and Pharmacodynamics
Recruiting
Phase 2Interventional Study
Post Partum HemorrhageCesarean Section ComplicationsBlood Loss
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
100 (estimated)
Sponsor
Stanford University · Other
Who this trial is looking for
This trial is looking for women who are having a cesarean delivery and are between 18 and 50 years old. Participants will receive oxytocin right after delivery and provide blood samples to help understand how the drug works.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 50 years old
I am pregnant and have reached term
I am having a non-emergent cesarean delivery
You may not be able to join if
I am allergic to oxytocin
I cannot provide informed consent
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility 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 ox…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.