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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pre Term Labor Multiple Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

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

Minimum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes