PregnancyM•CARE SENCT05294211

Safety and Performance of a Fetal Monitoring System

A study testing M•care™ System and Cardiotocography (CTG) in people with Pregnancy, run by Marani Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pregnancy
What is being tested?: M•care™ System and Cardiotocography (CTG)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 31 Aug 2022to 24 Jan 2023
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to provide informed consent and follow study instructions
18 years of age or older
Pregnant subjects ≥ 32 weeks' gestation
Singleton pregnancy
BMI ≥15, pre-pregnancy
BMI ≤45, pre-pregnancy
Belly circumference ≥80 cm and ≤ 130 cm

Who cannot join

Known major fetal malformation or chromosome abnormality
Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation
Participants with implanted electronic devices (pacemakers, defibrillator, etc.)
Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
Medical or obstetric problem that in the investigator's opinion would make the participant incapable of taking part in the study
In the investigator's opinion, the participant is not likely to be available for the minimum 60 minutes of the monitoring session
History of skin allergies to cosmetics and lotions
Known allergies to silver, nylon, or polyester

Trial locations and contacts

1 site in 1 country.

United States1 site

NorthShore University Health System
Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study

The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.

Conditions: Pregnancy
Being tested: M•care™ System, Cardiotocography (CTG)
Keywords: antenatal monitoring, fetal monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

M•care™ SystemDevice
The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Cardiotocography (CTG)Device
A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)

Study groups in NCT05294211
Study group	Role	What they receive
M•care™ System + CTG	Experimental	The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring Receives: Device: M•care™ System; Device: Cardiotocography (CTG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Fetal Heart Rate (FHR)
FHR as measured by the M•care System versus standard of care CTG device
Measured: Up to 120 minutes
Maternal Heart Rate (MHR)
MHR as measured by the M•care System versus standard of care CTG device
Measured: Up to 120 minutes

Secondary outcomes (1)

Uterine Contractions (UC)
UC sensitivity as measured by the M•care System versus standard of care CTG device, where sensitivity is defined as the proportion of UC events identified by standard of care that are simultaneously identified by the M•care System (positive agreement).
Measured: Up to 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202224 Jan 2023

First posted24 Mar 2022
Study start31 Aug 2022
Primary completion24 Jan 2023
Study completion24 Jan 2023

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.
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
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05294211
Sponsor's protocol ID: MH-001
Acronym: M•CARE SE
Status last verified: Jan 2024
First submitted: 15 Mar 2022
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study
ClinicalTrials.gov ID: NCT05294211
Acronym / sponsor ID: M•CARE SE / MH-001
Conditions: Pregnancy
Keywords: antenatal monitoring, fetal monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Marani HealthIndustry (pharma, biotech, devices)
Study start: 31 Aug 2022 (actual)
Primary completion: 24 Jan 2023 (actual)
Study completion: 24 Jan 2023 (actual)
First posted: 24 Mar 2022 (actual)
Results: Posted 23 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
M•care™ System + CTG	Experimental	Device: M•care™ System, Device: Cardiotocography (CTG)The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Able to provide informed consent and follow study instructions
18 years of age or older
Pregnant subjects ≥ 32 weeks' gestation
Singleton pregnancy
BMI ≥15, pre-pregnancy

Key exclusion criteria (8 listed)

Known major fetal malformation or chromosome abnormality
Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation
Participants with implanted electronic devices (pacemakers, defibrillator, etc.)
Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
Medical or obstetric problem that in the investigator's opinion would make the participant incapable of taking part in the study

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
M•care™ SystemThe M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)	Device	M•care™ System + CTG
Cardiotocography (CTG)A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)	Device	M•care™ System + CTG

Primary outcome

Fetal Heart Rate (FHR)
Time frame: Up to 120 minutes
FHR as measured by the M•care System versus standard of care CTG device
Maternal Heart Rate (MHR)
Time frame: Up to 120 minutes
MHR as measured by the M•care System versus standard of care CTG device

1 secondary outcome

Uterine Contractions (UC)
Time frame: Up to 120 minutes

Results and safety

Results posted to the registry on 23 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M•Care™ System + CTG	120	80

Primary outcome: Fetal Heart Rate (FHR)

Time frame: Up to 120 minutes. Mean (Standard Deviation). Unit: BPM

Measure	M•Care™ System n = 79	Cardiotocography (CTG) n = 79
Value	140.1 (11.4)	140.0 (10.7)

Population analysed: The performance evaluable population was defined as the population of subjects who had at least one minute of concurrent data collection with both devices (M•care and CTG) and did not have any major protocol violations. Of the 80 subjects in the performance evaluable population, no FHR data are available for one subject.

Primary outcome: Maternal Heart Rate (MHR)

Time frame: Up to 120 minutes. Mean (Standard Deviation). Unit: BPM

Measure	M•Care™ System n = 79	Cardiotocography (CTG) n = 79
Value	83.4 (12.0)	83.1 (12.1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
M•Care™ System + CTG	0 of 120 (0%)	1 of 120 (0.8%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing M•care™ System and Cardiotocography (CTG) in people with Pregnancy, run by Marani Health at 1 site in United States.

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 7 inclusion and 8 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 23 May 2024). 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 (FHR) (time frame: Up to 120 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 NCT05294211.

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 23 May 2024.