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

Monica Healthcare

Status: Completed

Conditions: Pregnancy; Habitual Aborter; Weeks of Gestation 37 or More

Treatments: Device: Monica AN24 (K101081); Device: Philips 50XM

Study type: Interventional

Funder types: Industry

Identifiers

NCT01280357

MHL101801

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: Female

Ages: 15 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Monitor Philips 50XM (K954351)

Active Comparator group

Description:

CTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM

Treatment:

Device: Philips 50XM

Monica AN24 (K101801)

Experimental group

Description:

EHG Fetal Monitor

Treatment:

Device: Monica AN24 (K101081)