Fetal Heartbeat Tracings Clinical Trial
Official title:
A Study Aimed at Comparing Two Methods of Contractions Monitoring (Electrical Uterine Monitor - EUM vs. Tocodynamometer) for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.
Background:
Identification and measurement of uterine contractions throughout pregnancy and labor is
crucial to the well being of both mother and fetus. Prematurity is one of the major causes
for adverse pregnancy outcomes, and clinical decision-making often relies on uterine
frequency as recorded by a tocodynamometer, as well as on other methods including
sonographic cervical length, pelvic examination.
Objective:
To show that the use of the EUM in preterm labor is effective in establishing true preterm
labor.
Methods:
Currently, three methods of assessing uterine activity exist. The first, tocodynamometry, is
based on mechanical measurement of abdominal wall stiffness by a strain gauge placed
externally on the patient's abdomen. This method mainly displays the presence of a
contraction, its duration and the frequency of contractions. Yet, it fails to reflect the
actual quantity of baseline tone or contraction amplitude due to great variability in
placement and the gravida's body habitus. It is also unable to distinguish between true
contractions or maternal movements or maternal Valsalva maneuver such as in coughing,
straining or sneezing. These are the main reasons this technology is known to be unreliable
in many cases and shows high percentage of false positive and false negative results [1].
Another method for monitoring uterine contractions is an internal measurement of uterine
pressure via an Intra-Uterine Pressure Catheter (IUPC). While it is accurate in recording
intensity, duration and frequency of contractions, as well as uterine basal tone, it has two
principle limitations: the IUPC can only be used after rupture of the membranes, and the
introduction of a foreign object in the uterine cavity may result in chorioamnionitis.
The third method of evaluating uterine activity involves recording of the myometrial
electrical activity [2]. Initially, this was assessed in animal models by means of invasive
uterine EMG [3-6], followed by noninvasive EMG recordings from abdominal surface in humans
[7-10]. Several studies have attempted to correlate between term and preterm labor to
uterine EMG, with limited success [11-17]. However, although most traditional EMG devices
use only 2 electrodes, a multichannel, noninvasive EMG device have been used successfully in
previous studies, both in preterm and term pregnancies, and were proved as both safe and
accurate [18-25]. Recently, reliability studies were published, regarding the comparison to
tocodynamomtery, IUPC and electrical uterine monitoring, using a multichannel EMG, and
demonstrated the multichannel EMG is as good as the IUPC ('Gold Standard') and both
multichannel EMG and IUPC are superior to tocodynamometry in recording uterine activity
[26-27].
Study rational Premature labor and delivery heralds great costs to the healthcare system,
including admission costs, tocolytic treatment and side effects and neonatal treatment of
the preterm neonate. Unfortunately, the accuracy of diagnosing preterm labor is poor, with
less than 10% of women presenting with preterm labor symptoms actually delivering within 7
days of symptoms' onset [28], 30% with resolving symptoms and more than 50% delivering at
term [29]. Since IUPC cannot be used in women with intact membranes and tocodynamometry is
unreliable, with previous reports concluding that multichannel EMG is superior to
tocodynamomtery and comparable to IUPC, our objective is to evaluate the utility of the
multichannel EMG in women with preterm contractions.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02864225 -
To Compare the Efficacy Between 3 Fetal Monitoring Methods (EUM)
|
Phase 3 | |
| Recruiting |
NCT02331888 -
To Compare the Efficacy Between 3 Fetal Monitoring Methods
|
Phase 3 |