The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation \> 32+0 weeks of pregnancy. The main questions it aims to answer are to assess the agreement between femom data collection (FHR, MHR, UA), and values measured via the standard of care used for prenatal monitoring (i.e. CTG). The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces. Participants will have the femom device and CTG attached to their abdomen. The femom device will be attached for about 30 minutes while they are wearing the device for the NST.
Study Type
OBSERVATIONAL
Enrollment
120
FHR
The 95% confidence limits for the 95% limits of agreement (LoA) for FHR are within -10 and 10 bpm
Time frame: From 32 weeks gestation to labour
MHR
The 95% confidence limits for the 95% limits of agreement (LoA) for MHR are within -8 and 8 bpm
Time frame: From 32 weeks gestation to labour
PPA
The positive percentage agreement (PPA) for UA using femom with respect to Tocodynamometry (TOCO).
Time frame: From 32 weeks gestation to labour
Femom NST vs NST
To test concordance in clinical interpretability of femom NST traces and the standard of care CTG traces.
Time frame: From 32 weeks gestation to labour
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