Treatment for Bloodloss

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Chicago, Chicago, IL
Bloodloss+4 More
Eligibility
18 - 65
Female
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Study Summary

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 (or 'what the body does to the drug') of a single intravenous (IV) dose of deuterium-labeled oxytocin (a novel tracing method to distinguish this dose from pre-existing oxytocin in the body and the standard variable dosing given in cesarean delivery). The second part will measure the pharmacodynamics (or 'what the drug does to the body') 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.

Eligible Conditions

  • Bloodloss
  • Complications; Cesarean Section
  • Postpartum Haemorrhage (PPH)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: Intraoperatively (at the time of clamping of the umbilical cord)

Intraoperatively (1 minute following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 1 minute
Intraoperatively (10 minutes following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 10 minutes
Intraoperatively (15 minutes following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 15 minutes
Intraoperatively (2.5 minutes following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 2.5 minutes
Intraoperatively (20 minutes following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 20 minutes
Intraoperatively (30 minutes following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 30 minutes
Intraoperatively (45 minutes following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 45 minutes
Intraoperatively (5 minutes following clamping of the umbilical cord)
Plasma concentrations of deuterated oxytocin at 5 minutes
Intraoperatively (60 minutes following clamping of the umbilical cord)
0-10 Uterine Tone Score
Plasma concentrations of deuterated oxytocin at 60 minutes
Intraoperatively (at the time of clamping of the umbilical cord)
Baseline plasma concentrations of deuterated oxytocin

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

0 Treatment Group

100 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 2

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperatively (at the time of clamping of the umbilical cord)
Closest Location: University of Chicago · Chicago, IL
Photo of University of Chicago  1Photo of University of Chicago  2Photo of University of Chicago  3
2004First Recorded Clinical Trial
1 TrialsResearching Bloodloss
705 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.