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Antepartum Fetal Assessment

Poster Session 1

(285) Safety and performance of a cloud-based fetal and maternal monitoring system

Tuesday, February 13, 2024
10:30 AM – 12:00 PM  
Location: Prince George's Exhibit Hall CDE, Lower Atrium Level
Objective: To demonstrate the safety and performance of a remote, wireless, cloud-based monitoring system for fetal and maternal heart rate (FHR and MHR). Uterine activity (UA) monitoring was assessed as a secondary objective.

Study Design: A multi-center, single-arm, prospective paired comparison study was conducted to evaluate safety and compare FHR and MHR acquired with a new antenatal monitoring system (M•care System, Marani Health) to simultaneously acquired FHR and MHR measured with a standard cardiotocography (CTG) device and pulse-oximetry, respectively. UA was compared against tocodynamometry (TOCO). Eligible subjects had singleton pregnancies with gestations ≥ 32 weeks and BMI between 15 and 45 kg/m2. Recruitment occurred on Labor and Delivery units, antepartum floors and outpatient settings across three sites. Bland-Altman 95% Limits of Agreement (LoA95) between the M•care System and CTG measures and pulse oximetry were compared against equivalence thresholds of 15 beats per minute (BPM) for FHR and 10 BPM for MHR. Three blinded physicians independently assessed M•care UA in comparison to TOCO.

Results: Performance data was available for 80 subjects. Demographic and clinical characteristics of the study population are displayed (Table). Between device FHR differed by 0.18±4.77 (mean±SD) BPM, with a lower LoA95 [95% CI] of -4.45 [-5.26, -3.61] and upper LoA95 of 6.64 [5.25, 8.45] BPM. Between device MHR differed by 0.28±2.48 (mean±SD) BPM, with a lower LoA95 [95% CI] of 2.26 [-2.74, -1.95] and upper LoA95 of 2.93 [2.52, 3.32] BPM. However, only 57% of TOCO contractions were detected in M•care UA. One mild adverse event occurred, a skin reaction to the exfoliating agent, prior to placement of the study device.

Conclusion: The M•care System is safe and its performance is comparable to CTG and pulse oximetry. It is not sufficiently sensitive to measure UA. This technology could support home-based antenatal maternal and fetal monitoring to enable patients and providers to connect efficiently and potentially reduce patient travel and childcare burden.