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Femom System Compared to the Standard of Care CTG
Sponsor: Biorithm Pte Ltd
Summary
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.
Official title: A Clinical Study Evaluating the Safety and Performance of the Femom System Compared to the Standard of Care CTG for Antepartum Fetal Monitoring.
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2024-07
Completion Date
2025-07
Last Updated
2024-07-08
Healthy Volunteers
Yes