Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/13/2015 |
| Start Date: | November 2013 |
The specific goal of the proposed research is to develop a reliable, non-invasive fetal and
maternal heart rate and contraction monitor that is unaffected by obesity and requires less
nursing intervention than the tocodynamometer and Doppler ultrasound.
maternal heart rate and contraction monitor that is unaffected by obesity and requires less
nursing intervention than the tocodynamometer and Doppler ultrasound.
The majority of obstetric deliveries in the US undergo electronic monitoring and continuous
uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically,
external transducers are employed, the reliability of which depends on their proper
positioning, which may be disturbed by patient or fetal movement. The tocodynamometer
(strain gauge, toco for short) provides frequency and timing of contractions, but requires
transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an
external Doppler ultrasound transducer. The reliability of this monitor depends on the
ability to obtain a window to the fetal heart.
In some patients, particularly the obese, the toco and ultrasound may fail to monitor
consistently. In others both transducers require frequent repositioning by the nursing
staff, and the Doppler may erroneously report maternal heart rate instead of fetal.
The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which
is placed through the cervical os in the adequately dilated patient with ruptured membranes.
While this monitor usually provides a more reliable signal than the toco, as well as
quantitative information regarding intrauterine pressure, it is invasive and there is an
increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE),
which is applied transvaginally to the fetal presenting part, also requiring adequate
cervical dilation and ruptured membranes. While the FSE usually provides a more reliable
signal, it is similarly invasive and increases risk of infection.
Maternal obesity (defined as BMI at presentation ≥ 30) is an ever-increasing problem in the
US, and is even more prominent in the obstetric suite. Meanwhile, obese women have an
increased risk for labor problems, infections and other complications. Noninvasive labor
monitoring, while preferable to reduce the infection risk, is particularly unreliable in
this population.
uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically,
external transducers are employed, the reliability of which depends on their proper
positioning, which may be disturbed by patient or fetal movement. The tocodynamometer
(strain gauge, toco for short) provides frequency and timing of contractions, but requires
transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an
external Doppler ultrasound transducer. The reliability of this monitor depends on the
ability to obtain a window to the fetal heart.
In some patients, particularly the obese, the toco and ultrasound may fail to monitor
consistently. In others both transducers require frequent repositioning by the nursing
staff, and the Doppler may erroneously report maternal heart rate instead of fetal.
The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which
is placed through the cervical os in the adequately dilated patient with ruptured membranes.
While this monitor usually provides a more reliable signal than the toco, as well as
quantitative information regarding intrauterine pressure, it is invasive and there is an
increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE),
which is applied transvaginally to the fetal presenting part, also requiring adequate
cervical dilation and ruptured membranes. While the FSE usually provides a more reliable
signal, it is similarly invasive and increases risk of infection.
Maternal obesity (defined as BMI at presentation ≥ 30) is an ever-increasing problem in the
US, and is even more prominent in the obstetric suite. Meanwhile, obese women have an
increased risk for labor problems, infections and other complications. Noninvasive labor
monitoring, while preferable to reduce the infection risk, is particularly unreliable in
this population.
Inclusion Criteria:
- Parturients presenting to Labor & Delivery for labor at term (>36 weeks completed
gestation)
- Single viable fetus in cephalic presentation
- With FSE or IUPC for obstetric indications
Exclusion Criteria:
- Multi fetal gestation
- Contraindication to FSE or IUPC placement
- Insufficient abdominal space for all required sensors
We found this trial at
1
site
Click here to add this to my saved trials
