CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03898882
NCT03898882N/ACompleted
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The Pharmacokinetics of Oxytocin in Pregnant Women Undergoing Cesarean Delivery - a Feasibility Pilot Study

Washington University School of Medicine·observational·Posted Apr 2, 2019·Updated May 7, 2020

In Brief

An observational study evaluating oxytocin and Shore durometer for Postpartum Hemorrhage. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The primary objective is to obtain data to inform the design of a population pharmacokinetic study of oxytocin after administration at CD as per standard institutional practice.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Hemorrhage
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 2, 2019
Enrollment StartMay 24, 2019
Primary CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.3 years ago

Interventions

oxytocindrug

PK measurements of oxytocin

Shore durometerdevice

The investigators will take serial readings from a digital durometer at the uterine fundus at 3, 6, 9 and 12 minutes following OXT administration to provide data that will inform an estimate of the timing of peak effect. Shore durometers measure the hardness of materials on a scale of 0-100 Shore Units (SU). Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery. Durometer readings were also shown to correlate positively with the obstetrician's manual assessment of uterine contractility, which is traditionally used to determine the success or failure of uterotonic therapy.