Intrapartum non-invasive electrophysiological monitoring: A prospective observational study.

INTRODUCTION: Doppler ultrasound cardiotocography is a non-invasive alternative that, despite its poor specificity, is often first choice for intrapartum monitoring. Doppler ultrasound suffers from signal loss due to fetal movements and is negatively correlated with maternal body mass index (BMI). Reported accuracy of fetal heart rate monitoring by Doppler ultrasound varies between 10.6 and 14.3 bpm and reliability between 62.4% and 73%. The fetal scalp electrode (FSE) is considered the reference standard for fetal monitoring but can only be applied after membranes have ruptured with sufficient cervical dilatation and is sometimes contra-indicated. A non-invasive alternative that overcomes the shortcomings of Doppler ultrasound, providing reliable information on fetal heart rate, could be the answer. Non-invasive fetal electrocardiography (NI-fECG) uses a wireless electrode patch on the maternal abdomen to obtain both fetal and maternal heart rate signals as well as an electrohysterogram. We aimed to validate a wireless NI-fECG device for intrapartum monitoring in term singleton pregnancies, by comparison with the FSE. MATERIAL AND METHODS: We performed a multicenter cross-sectional observational study at labor wards of 6 hospitals located in the Netherlands, Belgium, and Spain. Laboring women with a healthy singleton fetus in cephalic presentation and gestational age between 36 and 42 weeks were included. Participants received an abdominal electrode patch and FSE after written informed consent. Accuracy, reliability, and success rate of fetal heart rate readings were determined, using FSE as reference standard. Analysis was performed for the total population and measurement period as well as separated by labor stage and BMI class (≤30 and >30 kg/m2 ). RESULTS: We included a total of 125 women. Simultaneous registrations with NI-fECG and FSE were available in 103 women. Overall accuracy is -1.46 bpm and overall reliability 86.84%. Overall success rate of the NI-fECG is around 90% for the total population as well as for both BMI subgroups. Success rate dropped to 63% during second stage of labor, similar results are found when looking at the separate BMI groups. CONCLUSIONS: Performance measures of the NI-fECG device are good in the overall group and the separate BMI groups. Compared with Doppler ultrasound performance measures from the literature, NI-fECG is a more accurate alternative. Especially, when women have a higher BMI, NI-fECG performs well, resembling FSE performance measures.

Acceptance of a new non-invasive fetal monitoring system and attitude for telemedicine approaches in obstetrics: a case-control study.

PURPOSE: Reduction of maternal morbidity and mortality is a major worldwide objective anchored in the millennium goals of the United Nations. To improve fetal and maternal care, a constant attempt to discover groundbreaking technologies is ongoing. One approach is the enhancement of non-invasive fetal ECG devices. Most importantly, acceptance of new technologies by pregnant women is a prerequisite for successful implementation. METHODS: This questionnaire-based study conducted at the University Hospital Heidelberg, Germany between May and June 2017 evaluates pregnant women's attitudes towards a new device for fetal ECG monitoring and its potential home usage. The study population was questioned after exposure to the Parides/Atlantis prototype (Nemo Healthcare, Veldhoven, The Netherlands), whereas the maternal and gestational age-matched control group was left to envision telemedical topics. RESULTS: The prototype and its potential usage in a clinical and telemedical setting was highly accepted, and its comfort and appearance satisfied participants. Its use caused significantly improved telemedical understanding as envision increased (p = 0.0015). Implementation and integration of telemedical devices into antenatal care was significantly preferred by the study group (p = 0.0011), though participants desire more specific features for their personal use. Optional home-based self-monitoring to reduce scheduled doctoral visits (p = 0.0004) as well as self-assessment prior to self-initiated, unscheduled consultation (p < 0.0001) could be affected positively by such a device. Furthermore, it could reduce face-to-face interaction with the care provider (p = 0.0163). CONCLUSIONS: The positive feedback on remote self-monitoring might open options for a more "patient as partners" oriented prenatal care in the future. Safety and reliability remain a major issue. More comprehensive studies with new technologies are needed to diligently ensure quality of care. Finally, results for new technologies must be communicated to pregnant women for their acceptance and usage of new devices.

Normal ranges for fetal electrocardiogram values for the healthy fetus of 18-24 weeks of gestation: a prospective cohort study.

BACKGROUND: The fetal anomaly ultrasound only detects 65 to 81 % of the patients with congenital heart disease, making it the most common structural fetal anomaly of which a significant part is missed during prenatal life. Therefore, we need a reliable non-invasive diagnostic method which improves the predictive value for congenital heart diseases early in pregnancy. Fetal electrocardiography could be this desired diagnostic method. There are multiple technical challenges to overcome in the conduction of the fetal electrocardiogram. In addition, interpretation is difficult due to the organisation of the fetal circulation in utero. We want to establish the normal ranges and values of the fetal electrocardiogram parameters in healthy fetuses of 18 to 24 weeks of gestation. METHODS/DESIGN: Women with an uneventful singleton pregnancy between 18 and 24 weeks of gestation are asked to participate in this prospective cohort study. A certified and experienced sonographist performs the fetal anomaly scan. Subsequently, a fetal electrocardiogram recording is performed using dedicated signal processing methods. Measurements are performed at two institutes. We will include 300 participants to determine the normal values and 95 % confidence intervals of the fetal electrocardiogram parameters in a healthy fetus. We will evaluate the fetal heart rate, segment intervals, normalised amplitude and the fetal heart axis. Three months postpartum, we will evaluate if a newborn is healthy through a questionnaire. DISCUSSION: Fetal electrocardiography could be a promising tool in the screening program for congenital heart diseases. The electrocardiogram is a depiction of the intimate relationship between the cardiac nerve conduction pathways and the structural morphology of the fetal heart, and therefore particularly suitable for the detection of secondary effects due to a congenital heart disease (hypotrophy, hypertrophy and conduction interruption).

The electrical heart axis of the fetus between 18 and 24 weeks of gestation: A cohort study.

INTRODUCTION: A fetal anomaly scan in mid-pregnancy is performed, to check for the presence of congenital anomalies, including congenital heart disease (CHD). Unfortunately, 40% of CHD is still missed. The combined use of ultrasound and electrocardiography might boost detection rates. The electrical heart axis is one of the characteristics which can be deduced from an electrocardiogram (ECG). The aim of this study was to determine reference values for the electrical heart axis in healthy fetuses around 20 weeks of gestation. MATERIAL AND METHODS: Non-invasive fetal electrocardiography was performed subsequent to the fetal anomaly scan in pregnant women carrying a healthy singleton fetus between 18 and 24 weeks of gestation. Eight adhesive electrodes were applied on the maternal abdomen including one ground and one reference electrode, yielding six channels of bipolar electrophysiological measurements. After removal of interferences, a fetal vectorcardiogram was calculated and then corrected for fetal orientation. The orientation of the electrical heart axis was determined from this normalized fetal vectorcardiogram. Descriptive statistics were used on normalized cartesian coordinates to determine the average electrical heart axis in the frontal plane. Furthermore, 90% prediction intervals (PI) for abnormality were calculated. RESULTS: Of the 328 fetal ECGs performed, 281 were included in the analysis. The average electrical heart axis in the frontal plane was determined at 122.7° (90% PI: -25.6°; 270.9°). DISCUSSION: The average electrical heart axis of healthy fetuses around mid-gestation is oriented to the right, which is, due to the unique fetal circulation, in line with muscle distribution in the fetal heart.

The Noninvasive Fetal Electrocardiogram During Labor: A Review of the Literature.

IMPORTANCE: The introduction of the cardiotocogram (CTG) during labor has not been found to improve neonatal outcome. The search for a more reliable, less invasive, and patient-friendly technique is ongoing. The noninvasive fetal electrocardiogram (NI-fECG) has been proposed as one such alternative. OBJECTIVES: The aim of this study was to review the literature on the performance of NI-fECG for fetal monitoring during labor. Following the PRISMA guidelines, a systematic search in MEDLINE, EMBASE, and Cochrane Library was performed. Studies involving original research investigating the performance of NI-fECG during labor were included. Animal studies and articles in languages other than English, Dutch, or German were excluded. The QUADAS-2 checklist was used for quality assessment. A descriptive analysis of the results is provided. RESULTS: Eight articles were included. Pooled analysis of the results of the separate studies was not possible due to heterogeneity. All studies demonstrate that it is possible to apply NI-fECG during labor. Compared with Doppler ultrasound, NI-fECG performs equal or better in most studies. CONCLUSIONS AND RELEVANCE: NI-fECG for fetal monitoring is a promising noninvasive and patient-friendly technique that provides accurate information. Future studies should focus on signal quality throughout labor, with the aim to further optimize technical development of NI-fECG.

The standardized 12-lead fetal electrocardiogram of the healthy fetus in mid-pregnancy: A cross-sectional study.

INTRODUCTION: The examination of the fetal heart in mid-pregnancy is by ultrasound examination. The quality of the examination is highly dependent on the skill of the sonographer, fetal position and maternal body mass index. An additional tool that is less dependent on human experience and interpretation is desirable. The fetal electrocardiogram (ECG) could fulfill this purpose. We aimed to show the feasibility of recording a standardized fetal ECG in mid-pregnancy and explored its possibility to detect congenital heart disease (CHD). MATERIALS AND METHODS: Women older than 18 years of age with an uneventful pregnancy, carrying a healthy singleton fetus with a gestational age between 18 and 24 weeks were included. A fetal ECG was performed via electrodes on the maternal abdomen. After removal of interferences, a vectorcardiogram was constructed. Based on the ultrasound assessment of the fetal orientation, the vectorcardiogram was rotated to standardize for fetal orientation and converted into a 12-lead ECG. Median ECG waveforms for each lead were calculated. RESULTS: 328 fetal ECGs were recorded. 281 were available for analysis. The calculated median ECG waveform showed the electrical heart axis oriented to the right and inferiorly i.e. a negative QRS deflection in lead I and a positive deflection in lead aVF. The two CHD cases show ECG abnormalities when compared to the mean ECG of the healthy cohort. DISCUSSION: We have presented a method for estimating a standardized 12-lead fetal ECG. In mid-pregnancy, the median electrical heart axis is right inferiorly oriented in healthy fetuses. Future research should focus on fetuses with congenital heart disease.

The influence of betamethasone on fetal heart rate variability, obtained by non-invasive fetal electrocardiogram recordings.

BACKGROUND: Betamethasone is widely used to enhance fetal lung maturation in case of threatened preterm labour. Fetal heart rate variability is one of the most important parameters to assess in fetal monitoring, since it is a reliable indicator for fetal distress. AIM: To describe the effect of betamethasone on fetal heart rate variability, by applying spectral analysis on non-invasive fetal electrocardiogram recordings. STUDY DESIGN: Prospective cohort study. SUBJECTS: Patients that require betamethasone, with a gestational age from 24 weeks onwards. OUTCOME MEASURES: Fetal heart rate variability parameters on day 1, 2, and 3 after betamethasone administration are compared to a reference measurement. RESULTS: Following 68 inclusions, 12 patients remained with complete series of measurements and sufficient data quality. During day 1, an increase in absolute fetal heart rate variability values was seen. During day 2, a decrease in these values was seen. All trends indicate to return to pre-medication values on day 3. Normalised high- and low-frequency power show little changes during the study period. CONCLUSIONS: The changes in fetal heart rate variability following betamethasone administration show the same pattern when calculated by spectral analysis of the fetal electrocardiogram, as when calculated by cardiotocography. Since normalised spectral values show little changes, the influence of autonomic modulation seems minor.

A systematic review of prenatal screening for congenital heart disease by fetal electrocardiography.

BACKGROUND: Congenital heart disease (CHD) is the most common severe congenital anomaly worldwide. Diagnosis early in pregnancy is important, but the detection rate by two-dimensional ultrasonography is only 65%-81%. OBJECTIVES: To evaluate existing data on CHD and noninvasive abdominal fetal electrocardiography (ECG). SEARCH STRATEGY: A systematic review was performed through a search of the Cochrane Library, PubMed, and Embase for studies published up to April 2016 using the terms "congenital heart disease," "fetal electrocardiogram," and other similar keywords. SELECTION CRITERIA: Primary articles that described changes in fetal ECG among fetuses with CHD published in English were included. DATA COLLECTION AND ANALYSIS: Outcomes of interest were changes in fetal ECG parameters observed for fetuses with congenital heart disease. Findings were reported descriptively. MAIN RESULTS: Only five studies described changes observed in the fetal electrocardiogram for fetuses with CHD, including heart rate, heart rate variability, and PR, QRS, and QT intervals. Fetal ECG reflects the intimate relationship between the cardiac nerve conduction system and the structural morphology of the heart. It seems particularly helpful in detecting the electrophysiological effects of cardiac anatomic defects (e.g. hypotrophy, hypertrophy, and conduction interruption). CONCLUSIONS: Fetal ECG might be a promising clinical tool to complement ultrasonography in the screening program for CHD.