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OpenTrials
Completed

NCT Number: NCT05294211

Safety and Performance of a Fetal Monitoring System

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Primary location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

M•care™ System

Device

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)

Primary outcomes

  1. Fetal Heart Rate (FHR)

    Time frame: Up to 120 minutes

    FHR as measured by the M•care System versus standard of care CTG device

  2. Maternal Heart Rate (MHR)

    Time frame: Up to 120 minutes

    MHR as measured by the M•care System versus standard of care CTG device

Secondary outcomes

  1. Uterine Contractions (UC)

    Time frame: Up to 120 minutes

    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).

Sponsors and collaborators

Lead sponsor

Marani Health

Industry

Registry information

Official study title

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

Acronym: M•CARE SE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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