Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During LaborNCT05782296
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate
An observational study of Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor and Uterine Contractions, run by OB-Tools Ltd. at 3 sites in 2 countries.
Trial summary
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions, Obstetric Complication
- What is being tested?
- TrueLabor
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Feb 2022to 5 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women (age>18 y/o) in active labor following rupture of membranes and placement of an IUPC and/or FSE.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology
Hoffman Estates, Illinois, 60169
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate: TrueLabor™, A New External Monitoring Device: Prospective Observational Study
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
- Conditions
- Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions, Obstetric Complication
- Being tested
- TrueLabor
- Keywords
- Fetal Heart Rate, Uterine Activity, TrueLabor, OB Tools, Non invasive monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrueLaborDevice
Non invasive monitoring device
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications Receives: Device: TrueLabor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate
This will be performed using a Performance Goal
Measured: Through labor, until delivery
Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity
This will be performed using a Performance Goal
Measured: Through labor, until delivery
Secondary outcomes (1)
Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2)
Effect of BMI on the performance measures
Measured: Through labor, until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start24 Feb 2022
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- OB-Tools Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782296
- Sponsor's protocol ID
- CL-00002
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate: TrueLabor™, A New External Monitoring Device: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05782296
- Acronym / sponsor ID
- CL-00002
- Conditions
- Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions, Obstetric Complication
- Keywords
- Fetal Heart Rate, Uterine Activity, TrueLabor, OB Tools, Non invasive monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- OB-Tools Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Device: TrueLaborWomen in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women (age>18 y/o) in active labor following rupture of membranes and placement of an IUPC and/or FSE.
Key inclusion criteria (6 listed)
- Women who are on >=37w0d of gestation
- Maternal age > 18 years old
- Singleton pregnancy
- Cephalic presentation
- Patient requiring internal monitoring for obstetric indications
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrueLaborNon invasive monitoring device | Device | Cohort |
Primary outcome
Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate
Time frame: Through labor, until delivery
This will be performed using a Performance Goal
Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity
Time frame: Through labor, until delivery
This will be performed using a Performance Goal
1 secondary outcome
Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2)
Time frame: Through labor, until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- OB Tools websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor and Uterine Contractions, run by OB-Tools Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate (time frame: Through labor, until delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.