Date

2024-11-11

Protocol

Protocol changed

Item Changed

Primary outcome(s)

Previous Version

Agreement between Paxxy FHR with CTG and Paxxy MHR with pulse oximetry MHR will be analysed. The correlation and mean difference (95% confidence interval [CI]) between Paxxy and CTG measures of FHR and between PXXY and pulse oximeter measured MHR will be calculated. Bland Altman plots will be generated to show the agreement between the two monitoring methods. This will be done by plotting the difference in measurement between the two methods vs the average in measurement of the two methods. [Initial monitoring for 20 minutes with a standard CTG will be done after admission to ward. After about 5 minutes of mobilisation of the mother Paxxy monitoring and pulse oxymeter monitoring will be done for further 20 minutes.]

Next Version

Simultaneous Heart Rate Monitoring The FDA emphasized that the fetal and maternal heart rate assessments via CTG and Paxxy should be conducted simultaneously. Initially, our proposal suggested sequential monitoring due to technical limitations of the device. However, the Paxxy device has since been refined, enabling simultaneous operation with the CTG device without signal interference. This change will enhance the scientific validity of our study by allowing direct comparison on the same time scale. This also reduces the study duration and the discomfort for the patients. Patients will not have to spend any additional time being on a monitor just for the study.