Pharmacokinetics of Oxytocin at Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-24

Study Completion Date

2020-02-28

Brief Summary

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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.

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Detailed Description

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In this pilot study the investigators will compare plasma oxytocin concentrations measured in arterial and venous blood, after oxytocin administration at cesarean delivery, in order to assess the validity of venous samples. They will also measure oxytocinase to explore how levels vary around the time of delivery of the placenta and to assess the effect that this may have on the metabolism of oxytocin.

Conditions

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Postpartum Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BMI 20 - 29.9 kg/m2

oxytocin

Intervention Type DRUG

PK measurements of oxytocin

Shore durometer

Intervention Type DEVICE

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 Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery.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

BMI > 30 kg/m2

oxytocin

Intervention Type DRUG

PK measurements of oxytocin

Shore durometer

Intervention Type DEVICE

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.

Interventions

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oxytocin

PK measurements of oxytocin

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Term singleton pregnancy
* Age 18-45 years of age
* ASA classification 2 or 3
* Scheduled cesarean delivery under neuraxial anaesthesia

* Need for general anaesthesia
* Absence of consent
* Inability to communicate in English or other barrier to providing informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes