Study to Determine the Equivalence of the Monica AN24 Monitor to Predicate Devices for (FHR) and (UC) During Pre-term Labor and Multiples
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- equivalence with predicate device
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
equivalence with predicate device
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported