Laboring Women With Ultrasound and FSE Monitoring
Conditions
Keywords
Ultrasound, FSE, IUPC
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
OBMedical Company
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Rate Interpretability | 2 hours | The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electrode Sensor, FSE, Ultrasound Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and Ultrasound | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | Electrode Sensor, FSE, Ultrasound |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Region of Enrollment United States | 71 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
Fetal Heart Rate Interpretability
The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrode Sensor, FSE | Fetal Heart Rate Interpretability | 83.4 percentage of time the signals are inter | Standard Deviation 15.4 |
| Electrode Sensor, Ultrasound | Fetal Heart Rate Interpretability | 62.4 percentage of time the signals are inter | Standard Deviation 26.7 |