Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

• Sponsor: OB-Tools Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05782296
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 21.2
• Patients Per Site: 50
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

A clinical study designed to validate the TrueLabor™ device in monitoring Fetal Heart Rate and Uterine Activity during labor, vs. current standard of care

Condition or Disease	Intervention/Treatment	Phase
Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor (Diagnosis); Uterine Contractions; Obstetric Complication	Device: TrueLabor

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate: TrueLabor™, A New External Monitoring Device: Prospective Observational Study
• Actual Study Start Date: Feb 24, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cohort Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications	Device: TrueLabor; Non invasive monitoring device

Outcome Measures

Primary Outcome Measures

1. Positive percent agreement (PPA) compared to Gold Standard [Through labor, until delivery]

   A positive percent agreement ("PPA") with Gold Standard

2. Sensitivity and specificity compared to Gold Standard [Through labor, until delivery]

   Sensitivity and Specificity compared to Gold Standard

Secondary Outcome Measures

1. Effect of BMI [Through labor, until delivery]

   Accuracy per BMI subgroup

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467
2	Meir Medical Center	Kfar Saba		Israel

Sponsors and Collaborators

• OB-Tools Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• OB Tools website

Publications

None provided.

• Responsible Party: OB-Tools Ltd.
• ClinicalTrials.gov Identifier: NCT05782296
• Other Study ID Numbers: CL-00002
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by OB-Tools Ltd.: Fetal Heart Rate; Uterine Activity; TrueLabor; OB Tools; Non invasive monitoring
• Additional relevant MeSH terms: Congenital Abnormalities; Disease

Study Results

No Results Posted as of Mar 23, 2023