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Pharmacokinetics of Oxytocin at Cesarean Delivery

NCT03898882 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-05-07

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

oxytocin

PK measurements of oxytocin

DEVICE

Shore durometer

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 Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery.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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • David T Monks, MBChB · Washington University School of Medicine

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-24
Primary Completion
2020-02-28
Completion
2020-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898882 on ClinicalTrials.gov