Pregnancy
Conditions
Keywords
Maternal Fetal Monitoring
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.
Interventions
DEVICEElectrode-based Sensor
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
Sponsors
Convergent Engineering, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women between the ages of 18 and 50 years old * \>/= 34 weeks gestation * Single viable fetus in cephalic presentation
Exclusion criteria
* Bleeding or uterine scarring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC | Stage I and II Labor | Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnthony Gregg, PhD
University of Florida
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Primary |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants |
| Sex/Gender, Customized Pregnant Women | 101 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 15 / 103 |
| serious Total, serious adverse events | 0 / 103 |
Outcome results
Primary
Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC
Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.
Time frame: Stage I and II Labor
Population: Pregnant women between the ages of 18-50 with a single viable fetus in stages I and/or II of labor
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electrode Sensor, TOCO and IUPC | Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC | TOCO patient group | 2.98 seconds | Standard Deviation 3.28 |
| Electrode Sensor, TOCO and IUPC | Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC | Electrode Sensor patient group | 3.95 seconds | Standard Deviation 2.65 |
Comparison: All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for TOCO and IUPC. Agreement between TOCO and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.95% CI: [1.7, 4.27]
Comparison: All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for the electrode sensor and IUPC. Agreement between electrode sensor and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.95% CI: [2.98, 4.92]