Oxytocin Pharmacokinetics and Pharmacodynamics Study
This study is looking at how oxytocin, a medicine used to help the uterus contract after childbirth, works in the body. Specifically, it's studying deuterated oxytocin (d5OT) in women having a non-emergency C-section. Researchers want to understand how the body processes d5OT (pharmacokinetics) and how different levels of oxytocin in the blood affect uterine contractions (pharmacodynamics). This information could help improve how oxytocin is used to prevent or treat heavy bleeding after delivery (postpartum hemorrhage). The study aims to enroll 100 women between 18 and 50 years old who are having a scheduled or unscheduled C-section.
- Study design
- This is an interventional study with an enrollment of 100 participants. It is not specified if it is randomized, blinded, or what phase it is in.
- What's involved
- You would have an extra IV inserted for blood draws during your C-section. Blood samples will be taken at several time points after receiving deuterated oxytocin and standard oxytocin, and uterine tone will be measured.
- Compensation
- Not stated in the trial record.
- Follow-up
- Blood samples and uterine tone measurements will be taken for up to 60 minutes after the study drug is given.
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Oxytocin Pharmacokinetics and Pharmacodynamics
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Naida M Cole, MD · PRINCIPAL_INVESTIGATOR · University of Chicago
Who to contact
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Inclusion
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What this trial measures
- Baseline plasma concentrations of deuterated oxytocinIntraoperatively (prior to delivery)
The plasma concentration of deuterium labelled oxytocin at baseline
- Plasma concentrations of deuterated oxytocin at 1 minuteIntraoperatively (1 minute following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 1 minute post-study drug
- Plasma concentrations of deuterated oxytocin at 2.5 minutesIntraoperatively (2.5 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 2.5 minutes post-study drug
- Plasma concentrations of deuterated oxytocin at 5 minutesIntraoperatively (5 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 5 minutes post-study drug
- Plasma concentrations of deuterated oxytocin at 10 minutesIntraoperatively (10 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 10 minutes post-study drug
- Plasma concentrations of deuterated oxytocin at 15 minutesIntraoperatively (15 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 15 minutes post-study drug
- Plasma concentrations of deuterated oxytocin at 20 minutesIntraoperatively (20 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 20 minutes post-study drug
- Plasma concentrations of deuterated oxytocin at 30 minutesIntraoperatively (30 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 30 minutes post-study drug
- Plasma concentrations of deuterated oxytocin at 45 minutesIntraoperatively (45 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 45 minutes post-study drug
- Plasma concentrations of deuterated oxytocin at 60 minutesIntraoperatively (60 minutes following study drug administration)
The plasma concentration of deuterium labelled oxytocin at 60 minutes post-study drug
- 0-10 Uterine Tone ScoreIntraoperatively (at the time of study drug administration)
Uterine tone will be ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (1 minute following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (2.5 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (5 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (10 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (15 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (20 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (30 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (45 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.
- 0-10 Uterine Tone ScoreIntraoperatively (60 minutes following study drug administration)
Uterine tone ranked by the obstetrician on a 0-10 scale by palpation of the uterus. A score of 0 will represent 'no tone' and a score of 10 will represent 'perfect tone'. The relationship between plasma concentrations and clinical effect will be determined for pharmacodynamic modeling.