Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

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

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-24

Study Completion Date

2024-06-05

Brief Summary

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A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.

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Detailed Description

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Conditions

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Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor Uterine Contractions Obstetric Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications

TrueLabor

Intervention Type DEVICE

Non invasive monitoring device

Interventions

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TrueLabor

Non invasive monitoring device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women who are on \>=37w0d of gestation
* Maternal age \> 18 years old
* Singleton pregnancy
* Cephalic presentation
* Patient requiring internal monitoring for obstetric indications
* Informed consent

Exclusion Criteria

* Major fetal anomalies
* Patients with implanted electronic devices of any kind
* Patients using exterior electronic devices of any kind during the procedure
* Patients with irritated skin or open wound on the abdominal wall

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No