Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method

Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring

Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.

The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.

Inclusion Criteria:

• Pregnant, age 15-40
• Term gestation (>36 completed weeks)
• Singleton fetus
• Active labor
• Vertex presentation
• Requiring internal monitoring

Exclusion Criteria:

• Clinical contraindication for Intra Uterine Pressure Catheter
• Major fetal malformation