Date

2024-11-11

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

• All term mothers (37+0 - 41+7) presenting to the professorial unit of De Soysa Hospital for Women; • Have clinical indications for fetal monitoring; • Age 18-45 years.

Next Version

Lower cutoff of 32 weeks. The PregSense protocol used as a reference by the FDA includes participants from 32 weeks of gestation onward. To align with this, we propose modifying our inclusion criteria to recruit mothers from 32 weeks of gestation instead of 37 weeks. This adjustment will provide valuable insights into the Paxxy device's performance across various gestational ages, making our findings more comprehensive.