Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

OB-Tools

Status: Completed

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

Treatments: Device: TrueLabor

Study type: Observational

Funder types: Industry

Identifiers

NCT05782296

CL-00002

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Cohort

Description:

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

Treatment:

Device: TrueLabor