PregnancyNCT03504189
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
A study testing PregSense™ and Cardiotocopraphy (CTG) in people with Pregnancy, run by Nuvo-Group, Ltd. at 4 sites in 3 countries.
Trial summary
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- PregSense™ and Cardiotocopraphy (CTG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Mar 2018to 8 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age between 18-50
- Gestational age > 32 + 0 weeks
- Singleton gestation
- Ability to understand and sign informed consent
Who cannot join
- BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
- Multiple gestation
- Uncontrolled Hypertension
- Fetal Anomaly
- Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
- Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
- Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
Read the detailed description
PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.
- Conditions
- Pregnancy
- Being tested
- PregSense™, Cardiotocopraphy (CTG)
- Keywords
- Fetal monitoring, Prenatal monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregSense™Device
PregSense™ wearable device will be applied for maternal-fetal monitoring
Cardiotocopraphy (CTG)Device
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
| Study group | Role | What they receive |
|---|---|---|
| PregSense™ | Experimental | PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring Receives: Device: PregSense™; Device: Cardiotocopraphy (CTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Heart Rate
Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)
Measured: 30 Minutes
Maternal Heart Rate
Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)
Measured: 30 MInutes
Secondary outcomes (1)
Uterine Contractions
Compare uterine contractions from Pregsense™ versus CTG.
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Mar 2018
- Primary completion27 Jun 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvo-Group, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504189
- Sponsor's protocol ID
- CLP1000
- Status last verified
- Feb 2020
- First submitted
- 5 Mar 2018
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17.
PubMed 33345967
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
- ClinicalTrials.gov ID
- NCT03504189
- Acronym / sponsor ID
- CLP1000
- Conditions
- Pregnancy
- Keywords
- Fetal monitoring, Prenatal monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Nuvo-Group, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
Detailed description
PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| PregSense™ | Experimental | Device: PregSense™, Device: Cardiotocopraphy (CTG)PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female age between 18-50
- Gestational age > 32 + 0 weeks
- Singleton gestation
- Ability to understand and sign informed consent
Key exclusion criteria (7 listed)
- BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
- Multiple gestation
- Uncontrolled Hypertension
- Fetal Anomaly
- Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
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 |
|---|---|---|
| PregSense™PregSense™ wearable device will be applied for maternal-fetal monitoring | Device | PregSense™ |
| Cardiotocopraphy (CTG)Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring | Device | PregSense™ |
Primary outcome
Fetal Heart Rate
Time frame: 30 Minutes
Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)
Maternal Heart Rate
Time frame: 30 MInutes
Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)
1 secondary outcome
Uterine Contractions
Time frame: 30 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33345967Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17.
- Individual participant dataSharing planned: No
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PregSense™ and Cardiotocopraphy (CTG) in people with Pregnancy, run by Nuvo-Group, Ltd. at 4 sites in 3 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 4 inclusion and 7 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, 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?
Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fetal Heart Rate (time frame: 30 Minutes). 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?
On the ClinicalTrials.gov record for NCT03504189, which also lists 1 linked publication.
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 18 Feb 2020.