Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies

Monica Healthcare Ltd8 enrolled

Overview

The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.

Clinical Investigation for a non-inferiority/equivalence study that aims to determine the acceptable performance of the Monica AN24 during the first and when possible the second stages of labor by determining whether the Monica AN24 fetal heart rate (FHR) and uterine contractions (UC) monitoring device is non-inferior/equivalent to Doppler FHR and tocodynamometer UC using direct fetal scalp electrode (FSE) FHR and intrauterine pressure catheter (IUPC) UC as a reference, either collected simultaneously with the Monica and Doppler FHR/tocodynamometer UC data, or from previous studies to define the expected accuracy and success rate when comparing Monica FHR and UC with Doppler FHR and tocodynamometer UC respectively

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pre Term Labor Multiple Pregnancy

Eligibility

Sex: FEMALEMin age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * She is \>=24weeks 0days but less than 36 completed weeks, with a singleton pregnancy or \>=34weeks 0days with a multiple pregnancy and has been admitted to the Labor and Delivery Unit * She is in the latent phase of spontaneous labor, or has been admitted for induction of labor * She has given her informed consent to participate as a subject * She has none of the exclusion criteria Exclusion Criteria: * Known major fetal malformation or chromosome abnormality * Involvement in another clinical trial currently or previously in this pregnancy * Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, sensitivity to adhesives) * Significant medical or obstetric problem that in the investigator's opinion would make the woman incapable of taking part in the study

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

equivalence with predicate device

Time frame: 12 months

Data from ClinicalTrials.gov

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