None listed
Conditions
Brief summary
The fetal heart rate device (HEARD) is a novel device developed by BIORITHM, a medical technology company, to assess fetal heart rate. For the following study, the current phase entails a proof of concept in women antenatally to assess the quality of signals obtained on HEARD. Aims 1. Examine the signal quality of fetal electrocardiogram signals obtained on various electrodes 2. Elicit patient opinion about utilising HEARD ( i.e. What do patients think?) Research design The following study is a cross sectional survey with a cohort design. Methods Primary outcomes: 1. Quantifying signal quality across various electrodes utilising HEARD 2. Correlation between signal quality and placental location, fetal back position and amniotic fluid index Secondary Outcomes 1. Patient views on HEARD (i.e pros, cons, will they recommend it)
Interventions
Patients will have an ultrasound prior to applying the fetal heart rate device (HEARD) to obtain information on location of the fetal back, placental location and amniotic fluid index.
Patients will then have HEARD attached to their abdomen to monitor the fetal hear rate through a number of electrodes to acquire signals using adbominal fetal electrocardiogram. This will take approximately 15 minutes
Sponsors
Monash University Department of Obstetrics and Gynaecology
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Should be above 24 weeks of pregnancy Should have a valid indication for antenatal fetal hear rate monitoring as part of their pregnancy management
Exclusion criteria
Women below 18 years of age Patients with an intellectual or mental impairment People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process People highly dependent on medical care
Outcome results
None listed