None listed
Conditions
Brief summary
During pregnancy, one modality of ensuring the well-being of the fetus is by measuring the heart rate. At present, the mainstay of such fetal surveillance is carried out by utilising cardiotocography (CTG). The CTG utilises Doppler ultrasound to approximate the FHR by detecting the movement of cardiac structures, which requires signal modulation and auto correlation to provide accurate quality recordings of FHR (Smith et al. 2018). Some of the main limitations with CTG are its inability to support mobile, ambulatory and accurate FHR monitoring. This is particularly worse in women with obesity, where there is the need for clinician oversight during its placement so as to ensure that the maternal heart rate (MHR) is not wrongly monitored over the FHR and that an interpretable trace is obtained. The limitations of CTG use prompted a Singapore based medical technology company, Biorithm, to investigate new methods of fetal monitoring using fetal ECG. This subsequently led to the prototyping of a new device, Femom, which can obtain and analyse fetal heart rate patterns in an outpatient setting. The output from the device will mirror available CTG technology and will therefore be interpreted in line with pre-existing available CTG guidelines. Femom utilises trans-abdominal electrocardiogram (ECG) to measure the fetal and maternal heart rates. Routine data collection at the National University Hospital in Singapore and Monash Medical Centre in Melbourne supports the ability of Femom to collect FHR patterns and contractions. No adverse effects were reported. This study will pilot a clinical trial aiming to examine the efficacy of Femom. Similar technology has also been previously used to monitor the fetus of women in clinical populations with no documented adverse effects (Reinhard et al., 2012). The device presently comprises of 5 electrodes which will be attached to the woman’s abdomen. Our primary research focus encompasses pilot testing the efficacy of Femom in comparison to traditional CTG monitoring to evaluate the quality of tracing obtained. The aims of the project are: 1. to assess the similarity between fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA) measured by Femom vs CTG, and 2. to assess whether there are any differences in fetal heart short term variation (STV) measured by Femom versus CTG 3. to pilot and inform the design of a future confirmatory study
Interventions
Non invasive monitoring of pregnant women of at least 28 weeks' gestation with a new device known as 'Femom' which utilises abdominal electrocardiogram as a basis for operation. For data collection, the device connects to 5 wet-gel electrodes which will be attached to the abdomen of the participating pregnant woman. The device will measure maternal and fetal physiologic parameters and uterine activity, on one occasion per women, for a minimum of 20 minutes.
Participating women will be concomita
Non invasive monitoring of pregnant women of at least 28 weeks' gestation with a new device known as 'Femom' which utilises abdominal electrocardiogram as a basis for operation. For data collection, the device connects to 5 wet-gel electrodes which will be attached to the abdomen of the participating pregnant woman. The device will measure maternal and fetal physiologic parameters and uterine activity, on one occasion per women, for a minimum of 20 minutes. Participating women will be concomitantly monitored with the cardiotocograph (CTG), currently standard care. The intervention will be administered by registered midwives employed by the clinical site (Royal North Shore Hospital) to conduct fetal monitoring as deemed necessary by treating obstetricians at the site. The intervention will be delivered in the Day Assessment Unit at the Royal North Shore Hospital where women routinely receive fetal monitoring during pregnancy.
Sponsors
University of Technology Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Singleton pregnancy At or above 28 weeks' gestation. Able to understand English or have access to an interpreter Able to provide informed consent
Exclusion criteria
Multiple pregnancy Below 18 years of age Intellectual impairment Known allergy or sensitivity to ECG gel electrodes In labour, experiencing painful contractions Known fetal cardiac or genetic abnormality Pacemaker
Outcome results
None listed