Pregnancy Related Clinical Trial
Official title:
Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions
Patients receiving oxytocin for induction or augmentation of labor will be studied with uterine EMG. The results of the EMG will be converted to an oxytocin-associated uterine stimulation index (uSI), which is intended to guide decisions for changing the dose of oxytocin. An expert panel will review the results of the oxytocin dosing actions, then assigned optimized actions throughout the labor. The uSI will be correlated with the optimal dosing actions.
Background. Oxytocin stimulates the uterus, increases the strength and frequency of uterine
contractions and facilitates delivery. The "dose" of oxytocin is the rate of IV infusion. In
a typical labor where oxytocin is used, many dosing adjustments are performed over many
hours. Finding the correct dose for a given patient is challenging because some women respond
rapidly to low doses of oxytocin, others require high doses. The correct dose is important
because the risks of adverse outcomes increase when doses are either too low or excessive.
The dosing actions increase, hold, decrease or stop are typically performed every 30 minutes
during oxytocin administration.
Dosing actions are performed based on the current level of simulation caused by the current
dose. To assess the level of stimulation, current methods rely heavily on the output of the
fetal monitor, which produces contraction frequency and fetal heart rate. Additional
information for dosing decisions is obtained from subjective assessments such uterine
palpation. Subjective measures are used because there is no objective method available to
reliably guide a dosing action. Subjectivity is a major contributor to the long duration of
labor for inductions and the high rate of excessive uterine stimulation with any oxytocin
use.
The uterine stimulation index (uSI) is an objective measure of the current level of
stimulation caused by the current dose of oxytocin in individual patients and can be used to
guide oxytocin dosing actions. uSI is based on an electromyography (EMG) signal that is
proportional to the effects of oxytocin on the uterine muscle. uSI is calculated from
multichannel EMG to obtain a representative sampling of the effects of oxytocin on entire
uterus. The range of values for uSI is from 0 (no oxytocin effects) to 10 (maximal oxytocin
effects). Low values of uSI guide the end-user to increase the current dose of oxytocin.
Intermediate values of uSI guide the end-user to hold the current dose. High values of uSI
guide the end-user to decrease the current dose.
The purpose of this study is to establish the ranges of uSI values that correspond to the
dosing actions increase, hold and decrease. To establish these ranges, 51 subjects will
undergo current methods of dosing while having multichannel EMG recorded. uSI values will not
be available to end-users, so all subjects will receive dosing actions determined by standard
of care using current method. After delivery, a panel of experts will retrospectively assess
each dosing action based on the outcome of the dosing action. These "optimized dosing
actions" will then be correlated with the uSI value obtained at that time. This process
produces paired data of optimized actions and uSI values. From the clustering of the uSI
values, the ranges of uSI can be matched to the dosing actions increase, hold and decrease.
As a second goal, human factors will be studied with questionnaires and end-user interviews
to improve the methods used for recording multichannel EMG during labor.
Procedure. Patients receiving oxytocin for clinical indications will be approached for
participation. After obtaining consent, up to 8 proprietary EMG sensors will be placed over
the subject's abdomen, spanning most of the surface of the uterus. Additionally, one ground
sensor and one noise rejection sensor will be placed. Multichannel EMG recordings will be
obtained throughout the labor, although the results of the EMG will not be available to the
obstetrical providers. Subjects will be managed using current methods of monitoring and
standard of care for oxytocin dosing decisions.
At the conclusion of the recording, the EMG sensors will be removed from the subject. Data
will be analyzed after delivery, producing uSI values as a function of time for the duration
of the labor.
An expert panel will be assembled, composed of clinicians trained in the art of obstetrics
and managing oxytocin. The progress of labor will be assessed by examining the fetal monitor
strip (i.e. uterine contractile activity and the fetal heart rate over time), cervical
changes, and the dosing actions performed. No less than 72 hours after delivery the neonate's
and subject's medical records will be reviewed to identify complications of the delivery that
may have occurred.
The expert panel will assess each dosing action as optimal or not optimal. An example of a
not optimal action would be increasing the dose and causing uterine tachysytole. In this
example, "hold" will be assigned as the optimized dosing action. Each subject will have a
list of optimized dosing actions and the time they were performed. Optimized dosing actions
will then be linked with uSI values observed at that time, creating a paired data set of uSI
values and optimal dosing actions.
The optimized dosing actions increase, hold and decrease will be correlated with uSI values
and the range of uSI values that correspond with each dosing action will be established.
End-users will be interviewed 1 to 72 hours after delivery of the baby. The interview will
identify barriers to EMG recording may influence the effectiveness of the information
provided by the multichannel EMG recording.
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